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Wang, D., E. Heath, A. Powell, T. Chaperon, F. LaGrone, and P. LoRusso. "Barriers to phase I clinical trial protocol IRB approval at KCI." Journal of Clinical Oncology 25, no. 18_suppl (2007): 9080. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.9080.
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9080 Phase I oncology clinical trials are critical in the oncology drug development process. To protect human subjects, every phase 1 protocol must be approved by an institutional review board (IRB) to assure safety before patient accrual. As the volume and complexity of phase 1 trials have increased, the amount of time spent on IRB protocol reviews have also increased for various reasons. Objectives: 1) Determine the average time spent on protocol approval by IRB at KCI/WSU; 2) Identify potential issues raised by IRB resulting in approval delays; 3) Identify the redundancies for which “standard language” implementation could facilitate future IRB applications thereby expediting approval. Methods: 96 Phase 1 research IRB applications at KCI/WSU between 8/1/2005 and 10/31/2006 were reviewed. These applications were stratified based on submission (new protocol versus amendment) and IRB approval (tabled, provisional or approved) status. Concerns frequently brought up by the IRB were identified. Results: The average and median time spent from initial submission to final approval of all 96 applications were 41.4 days and 43 days, respectively. Forty eight of 96 applications (50%) were provisionally approved from the initial review. Average and median time of obtaining final approval were 52.5 days and 52 days. Nine of 96 (9.4%) protocols were tabled with their average approval 83 days. The most common concerns raised by IRB were risks/benefit issues. These concerns were an even greater approval barrier when protocols involved specialized technologies of molecular therapeutics or complicated study designs. Regulatory policy changes issued by oversight organizations also required “real-time” updates into protocols and consent form amendments. Areas of “standard language” for future IRB applications are being compiled and will be discussed upon presentation. Conclusion: Phase 1 clinical trials are essential to anti-cancer drug development. The complicated ethical issues and science warrant an ongoing constructive collaboration of both parties. Identification of commonalities that delay IRB approval will lead to more expeditious IRB approval not only at our institution, but could also benefit other institutions. No significant financial relationships to disclose.
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Rodriguez, Emily, Challace Pahlevan-lbrekic, and Elaine L. Larson. "Facilitating Timely Institutional Review Board Review: Common Issues and Recommendations." Journal of Empirical Research on Human Research Ethics 16, no. 3 (2021): 255–62. http://dx.doi.org/10.1177/15562646211009680.
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Review of clinical research by institutional review boards (IRBs) is integral to the protection of human subjects and necessary for the conduct of legal and ethical research. Because such review is time and resource intensive, it is critical to identify common issues that contribute to delayed review and approval of research. Hence, the aim of this quality improvement project was to identify factors associated with long delays in IRB approval and identify potential strategies to streamline the review process. In collaboration with the human subjects research protection program at a large academic health center in the northeastern United States, we conducted a content analysis of minutes of convened IRB meetings for every new protocol (initial submission) approved between January and September 2019 that required greater than or equal to two full board reviews prior to approval ( n = 33). We also examined characteristics of new protocols that were reviewed less than twice at convened meetings during the same time frame ( n = 244). Using χ2 or Fisher's exact tests, the characteristics of protocols with multiple reviews by the convened IRBs were compared with those protocol submissions reviewed by the convened IRBs only once. Three factors significantly associated with increased delays were researcher conflict of interest (30% vs. 12%, respectively, p < .01), need for radiation safety evaluation (36% vs. 20%, respectively, p = .03), and protocols that were clinical trials (73% vs. 60%, respectively, p < .01). Other factors associated with delayed IRB approval were excessive technical jargon (93.94%, n = 31), inadequate description of data security or inability to meet data security requirements of the institution (75.76%, n = 25), protocol design affecting patient safety (57.58%, n = 19), and lack of clarity regarding compensation and payment or study duration ( n = 18, 54.54% each). Approaches to mitigate delays in approval and increase the efficiency and efficacy of the IRB process are recommended.
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Camacho, Luis H., Lisa Marubio, Michelle A. Purdom, et al. "Improving the Institutional Submission and Approval Process for Clinical Research Protocols in Oncology." Journal of Clinical Oncology 25, no. 12 (2007): 1632–33. http://dx.doi.org/10.1200/jco.2006.09.5422.
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Fortner, Clarence L., and Paul J. Vilk. "Aspects of Investigational Antineoplastic Agents." Journal of Pharmacy Practice 4, no. 1 (1991): 64–71. http://dx.doi.org/10.1177/089719009100400107.
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Investigational drugs are regulated by the Food and Drug Administration (FDA) and are not available for widespread patient use. They are screened and evaluated extensively before they are administered to humans in clinical trials. The clinical development process is divided into three phases: phase I, II, and III. Protocols for the investigational agent in each of these phases must be approved by an institutional review board and the patient must be informed of the risks of the study and sign an informed consent document. Once adequate clinical data are collected and analyzed, the information is submitted to the FDA for their review and approval for marketing. Prior to that approval, the FDA may approve broader distribution of the drug for specific indications under a Treatment Investigational New Drug (IND) or the National Cancer Institute's (NCI) group C mechanism. Pharmacists can play a unique role during development of the Treatment IND by contributing to design of the protocol and screening patient qualifications. The investigator of the clinical trial has responsibility for the conduct of the clinical trial and must comply with FDA regulations and sponsor policies. This is a US government work. There are no restrictions on its use.
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Dietrich, Martin Frederik, Ning Ning, Jingsheng Yan, Xian-Jin Xie, and David E. Gerber. "Institutional scientific review of cancer clinical research protocols: Impact of requirement on activation timelines." Journal of Clinical Oncology 35, no. 15_suppl (2017): e18224-e18224. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e18224.
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e18224 Background: The National Cancer Institute (NCI) requirement that clinical trials at NCI-designated cancer centers undergo institutional scientific review in addition to Institutional Review Board review is unique among medical specialties. We evaluated the impact of this process on protocol activation timelines. Methods: We analyzed oncology clinical trials that underwent full board review by the Harold C. Simmons Comprehensive Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We analyzed associations between trial characteristics, PRMC decisions, protocol modifications, and process timelines using Chi-square test, Fisher’s exact test, Wilcoxon rank-sum test, Kruskal-Wallis test, and logistic regression. Results: A total of 226 trials were analyzed. Of these, 77% were industry-sponsored and 23% were investigator-initiated. While only 40% of trials were approved initially, 97% of trials were eventually approved after a mean of 0.6 protocol changes were requested and a mean of 0.5 protocol changes were implemented. Protocol changes were more likely to be requested ( P< 0.001) and implemented ( P= 0.008) for investigator-initiated trials. Median time from submission to PRMC approval was 55 days. The longest component interval was from submission initiation to completion of required documents by the study team (median 29 days). Total process duration depended on approval timing: median 35 days for first review, 68 days (2nd review), and 116 days (3rd review) ( P< 0.001). Similarly, process duration was also associated with the number of changes/clarifications requested: median 39 days for none, 64 days for 1-3, and 73 days for ≥4) ( P< 0.001). Requested changes/clarifications had greater impact on timelines for industry-sponsored trials than for investigator-initiated trials. Conclusions: NCI-mandated institutional scientific review of cancer clinical trials contributes substantially to protocol activation timelines. Further evaluation of this process and the value added to research quality is warranted.
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Ning, Ning, Jingsheng Yan, Martin F. Dietrich, Xian-Jin Xie, and David E. Gerber. "Institutional Scientific Review of Cancer Clinical Research Protocols: A Unique Requirement That Affects Activation Timelines." Journal of Oncology Practice 13, no. 12 (2017): e982-e991. http://dx.doi.org/10.1200/jop.2017.024299.
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Purpose: The National Cancer Institute (NCI) requirement that clinical trials at NCI-designated cancer centers undergo institutional scientific review in addition to institutional review board evaluation is unique among medical specialties. We sought to evaluate the effect of this process on protocol activation timelines. Methods: We analyzed oncology clinical trials that underwent full board review by the Harold C. Simmons Comprehensive Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We analyzed associations between trial characteristics, PRMC decisions, protocol modifications, and process timelines using the χ2 test, Fisher’s exact test, Wilcoxon rank sum test, Kruskal-Wallis test, and logistic regression. Results: A total of 226 trials were analyzed. Of these, 77% were industry sponsored and 23% were investigator initiated. The median time from submission to PRMC approval was 55 days. The length of review was associated with trial phase, timing of approval, and number of committee changes/clarifications requested. The median process time was 35 days for those approved at first decision, 68 days for second decision, and 116 days for third decision ( P < .001). The median process time was 39 days if no changes/clarifications were requested, 64 days for one to three changes/clarifications, and 73 days for four or more changes/clarifications ( P < .001). Requested changes/clarifications had a greater effect on industry-sponsored trials than on investigator-initiated trials. Conclusion: NCI-mandated institutional scientific review of oncology clinical trials contributes substantially to protocol activation timelines. Further evaluation of this process and the value added to research quality is warranted.
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Aziz, Kaiser Jay. "Gene Therapy: Development, Design of Studies, and Approval Process." Journal of Biotechnology & Bioinformatics Research 3, no. 3 (2021): 1–4. http://dx.doi.org/10.47363/jbbr/2021(3)134.
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Genome editing can be applied to various areas of medical diagnosis and treatments. Gene therapy pre-market applications comprise of systematically assessing a product’s design controls, manufacturing process controls, and proposed protocols for post-marketing surveillance. Quality risk management principles have been described in various FDA regulatory guidances for several aspects of good manufacturing practices (GMPs) such as several stages of process validation and verification in the genome product’s life cycle including critical quality attributes (CQAs) and monitoring critical process parameters (CPPs). A CPP is defined as a process parameter whose variability has an impact on a CQA of genome product and, therefore, should be monitored or controlled to ensure that the manufacturing process produces an end product of the desired quality. FDA’s mission is to facilitate the premarket review and evaluation of new genomic products for clinical use. The FDA guidances emphasize a quality management approach to the design of studies by providing oversight and objective review based on risk-benefit analysis of new genomic products. FDA reviews, evaluates, verifies and validates the implementation of the regulatory design-control requirements which are applied to the control genomic product’s quality throughout the total product life cycle (TPLC) [1-5].
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Spellecy, Ryan, and Thomas May. "More Than Cheating: Deception, IRB Shopping, and the Normative Legitimacy of IRBs." Journal of Law, Medicine & Ethics 40, no. 4 (2012): 990–96. http://dx.doi.org/10.1111/j.1748-720x.2012.00726.x.
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Deception, cheating, and loopholes within the IRB approval process have received significant attention in the past several years. Surveys of clinical researchers indicate common deception ranging from omitting information to outright lying, and controversy surrounding the FDA's decision not to ban “IRB shopping” (the practice of submitting protocols to multiple IRBs until one is found that will approve the protocol) has raised legitimate concerns about the integrity of the IRB process. One author has described a multicenter trial as being withdrawn from consideration at one institution when rejection was imminent, in order to avoid informing other IRBs reviewing the protocol of the study's rejection (a requirement under the federal regulations for emergency research with an exception from informed consent). This practice and IRB shopping seem at odds with the spirit, if not the “letter,” of the regulations. While at first blush these practices seem to cast aspersions on the integrity of clinical researchers, the moral issues raised go deeper than the ethics of cheating.
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Bernardes Neto, Saint Clair Gomes, Rodrigo Torres, Íllia Lima, Vanessa R. Resqueti, and Guilherme A. F. Fregonezi. "Weaning from mechanical ventilation in people with neuromuscular disease: protocol for a systematic review." BMJ Open 9, no. 11 (2019): e029890. http://dx.doi.org/10.1136/bmjopen-2019-029890.
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IntroductionNeuromuscular diseases (NMD) are characterised by progressive muscular impairment. The muscle weakness is directly related to respiratory muscles weakness, causing reduction in vital capacity, especially when associated with mechanical ventilation (MV). Conventional MV weaning in NMD is generally difficult. Weaning process can be conducted in protocols such as: ‘T’ piece or Pressure Support Ventilaton. Weaning failure is frequent because of muscle weakness. Protocol aim is to assess the effects of different weaning protocols in NMD patients receiving invasive MV in weaning success rate, duration of weaning, intensive care unit (ICU) stay, hospital stay and ICU mortality.Methods and analysisA search will be carried in the Cochrane Neuromuscular Specialised Register, MEDLINE, EMBASE, Web of Science, Scopus, United States National Institutes of Health Clinical Trials Registry, ClinicalTrials.gov and WHO International Clinical Trial Registry Protal, of randomised controlled trials (RCTs) and quasi-RCTs. Inclusion criteria of individuals are adults (above 16 years old) and children (from 5 to 16 years old), with clinical diagnosis of NMD (muscular dystrophy, amyotrophic lateral sclerosis, congenital myasthenia, myasthenia gravis, congenital myopathy, spinal muscular atrophy, Guillian Barré Syndrome, severe inherited neuropathies, metabolic myopathies, inflammatory myopathies, mitochondrial diseases) of any gender. All patients ventilated for at least 48 hours due to respiratory failure and clinically considered ready for weaning. Other respiratory or cardiovascular diagnosis associated will not be included. Intervention assessed will be weaning from MV using a protocol with 30 min to 2 hours of spontaneous breathing trial at the end point. All comparisons of different protocols will be considered.Ethics and disseminationFormal ethical approval is not required as primary data will not be collected, since it will be a systematic review. All studies included should have ethical committee approval. The results will be disseminated through a peer-reviewed publication and in conferences and congresses or symposia.PROSPERO registration numberCRD42019117393.
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Atkinson, Paul, Justin Bowra, James Milne, et al. "International Federation for Emergency Medicine Consensus Statement: Sonography in hypotension and cardiac arrest (SHoC): An international consensus on the use of point of care ultrasound for undifferentiated hypotension and during cardiac arrest." CJEM 19, no. 06 (2016): 459–70. http://dx.doi.org/10.1017/cem.2016.394.
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Abstract Introduction The International Federation for Emergency Medicine (IFEM) Ultrasound Special Interest Group (USIG) was tasked with development of a hierarchical consensus approach to the use of point of care ultrasound (PoCUS) in patients with hypotension and cardiac arrest. Methods The IFEM USIG invited 24 recognized international leaders in PoCUS from emergency medicine and critical care to form an expert panel to develop the sonography in hypotension and cardiac arrest (SHoC) protocol. The panel was provided with reported disease incidence, along with a list of recommended PoCUS views from previously published protocols and guidelines. Using a modified Delphi methodology the panel was tasked with integrating the disease incidence, their clinical experience and their knowledge of the medical literature to evaluate what role each view should play in the proposed SHoC protocol. Results Consensus on the SHoC protocols for hypotension and cardiac arrest was reached after three rounds of the modified Delphi process. The final SHoC protocol and operator checklist received over 80% consensus approval. The IFEM-approved final protocol, recommend Core, Supplementary, and Additional PoCUS views. SHoC-hypotension core views consist of cardiac, lung, and inferior vena vaca (IVC) views, with supplementary cardiac views, and additional views when clinically indicated. Subxiphoid or parasternal cardiac views, minimizing pauses in chest compressions, are recommended as core views for SHoC-cardiac arrest; supplementary views are lung and IVC, with additional views when clinically indicated. Both protocols recommend use of the “4 F” approach: fluid, form, function, filling. Conclusion An international consensus on sonography in hypotension and cardiac arrest is presented. Future prospective validation is required.
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Amaresh, K., Geetanjali Salimath, M. S. Ganachari, Revana S. Devarinti, and Uday Kumar. "A comparison of regulatory approval of clinical trial protocol with different countries." International Journal of Clinical Trials 8, no. 3 (2021): 260. http://dx.doi.org/10.18203/2349-3259.ijct20212849.
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<p class="abstract">In present scenario, different countries must follow different regulatory requirements for protocol approval process of new drug application. Present study, we studied the regulatory requirements, timelines of approval and guidelines according to central drug standard control organization (CDSCO), therapeutic goods administration (TGA), food and drug administration (FDA) and European medical agency (EMA). The objective was to compare the regulatory approval of clinical trial protocol process. A comparative observational study was undertaken among the clinical trials and regulatory bodies of India (CDSCO), Australia (TGA), US (USFDA), Europe (EMA). The study specified various regulatory guidelines and safety requirements for conduct and inspection of clinical trial. Clinical trial protocol guidelines the essential documents are determined, and various timelines are being identified. And compared with the fees with other countries. Indian payments were compared with other countries. Timelines with safety reporting were compared with other 3 countries (Europe, Australia and US). The regulatory guidelines in the clinical trial different between countries. There is different timelines and requirements of clinical trial application approval process for each regulatory body. This study methodology has enabled comparisons to be made both within agencies and between different authorities and has identified differences in the timelines that applications spend in different stages of the review.</p><p> </p>
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Diamond, Michael P., Esther Eisenberg, Hao Huang, et al. "The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials." Clinical Trials 16, no. 1 (2018): 3–10. http://dx.doi.org/10.1177/1740774518807888.
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Background/aims: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network. Methods: Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Results from two past clinical trials were also included. Results: While time required for actual institutional review board submission’s review and initial approval was reduced with use of a single institutional review board for multicenter trials (from a mean of 66.7–24.0 days), total time was increased (to a mean of 111.2 or 123.3 days). In addition to single institutional review board approval, all institutions required local approval of some components (commonly consent language and use of local language), which varied considerably. The single institutional review board relied on local institutions for adding or removing personnel, conflict of interest review, and auditing of activities. Conclusion: A single institutional review board reduced time for initial review and approval of protocols and informed consents, although time for the entire process was increased, as individual institutions retained oversight of components of required regulatory review. In order to best achieve the National Institute of Health’s goals for improved efficiency in initiation and conduct of multisite clinical research, greater coordination with local institutional review boards is key to streamlining and accelerating initiation of multisite clinical research.
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Watson, Lyndsey F., Jo-Anne Rayner, and Judith M. Lumley. "Hospital ethics approval for a population-based case–control study of very preterm birth." Australian Health Review 31, no. 4 (2007): 514. http://dx.doi.org/10.1071/ah070514.
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Aim: To describe the process involved in obtaining ethics approval for a study aiming to recruit women from all maternity hospitals in Victoria, Australia. Design: Observational data of the application process involving 85 hospitals throughout Victoria in 2001. Results: Twenty-three of the 85 hospitals had a Human Research Ethics Committee (HREC) constituted in accordance with the National Health and Medical Council requirements; 27 agreed to accept decisions from other hospitals having HRECs and 27 relied on ethics advisory committees, hospital managers, clinical staff, quality assurance committees or lawyers for ethics decisions. Four of the latter did not approve the study. Eight hospitals no longer provided maternity services in the recruitment period. The process took 16 months, 26 000 sheets of paper, 258 copies of the application and the cost was about $30 000. Approval was eventually obtained for recruitment at 73 hospitals. Discussion: Difficulties exist in obtaining timely ethics approval for multicentre studies due to a complex uncoordinated system. All hospitals should have explicit protocols for dealing with research ethics applications so that they can be processed in a straightforward and timely manner. To facilitate this, those without properly constituted HRECs should be affiliated with one hospital that has an HREC.
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Brassil, Donna, Roger Vaughan, Arlene Hurley, Kathleen Dowd, Richard Hutt, and Barry S. Coller. "4235 The Use of Checklists Throughout the Lifecourse of a Clinical Research Study: The Rockefeller University Checklist Suite." Journal of Clinical and Translational Science 4, s1 (2020): 69. http://dx.doi.org/10.1017/cts.2020.227.
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OBJECTIVES/GOALS: We have developed a comprehensive Translational Research Navigation Program to guide investigators all the way from protocol development through study closure. As the program evolved, we initially developed organizational tools and then restructured them into a series of checklists to ensure that critical elements were not excluded or duplicated. METHODS/STUDY POPULATION: A series of checklists to assure that all research elements, including regulatory, scientific, and institutional, are addressed from protocol inception through study closure were developed by clinical research coordinators/navigators. The checklists are periodically updated and modified to reflect changing local and national regulations and policies. The first tool became the “Protocol Development Checklist” and then additional tools were developed and modified into a suite of navigation checklists that include “Protocol Implementation Checklist,” “Protocol Conduct Checklist,” and “Protocol Completion Checklist.” RESULTS/ANTICIPATED RESULTS: The checklists have been incorporated into the Translational Research Navigation Program and have enhanced the organization and quality of protocols throughout their lifespan. For example, implementation of the Protocol Development Checklist resulted in a reduction in time to IRB approval (currently 10 days), and implementation of the Protocol Implementation Checklist has impacted the time from IRB approval to study start-up. The Protocol Conduct Checklist has aided investigators in being better prepared and more organized for study conduct activities and the Protocol Closure Checklist has assured timely protocol closure and regulatory compliance, including reporting to ClinicalTrials.gov. DISCUSSION/SIGNIFICANCE OF IMPACT: Protocol checklists are powerful tools to enhance thoroughness, organization, and quality of the clinical research process. The Rockefeller University protocol checklists are available to the CTSA and Scientific Communities. CONFLICT OF INTEREST DESCRIPTION: NA.
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Kurzrock, Razelle, Susan Pilat, Marcel Bartolazzi, et al. "Project Zero Delay: A Process for Accelerating the Activation of Cancer Clinical Trials." Journal of Clinical Oncology 27, no. 26 (2009): 4433–40. http://dx.doi.org/10.1200/jco.2008.21.6093.
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Drug development in cancer research is lengthy and expensive. One of the rate-limiting steps is the initiation of first-in-human (phase I) trials. Three to 6 months can elapse between investigational new drug (IND) approval by the US Food and Drug Administration and the entry of a first patient. Issues related to patient participation have been well analyzed, but the administrative processes relevant to implementing clinical trials have received less attention. While industry and academia often partner for the performance of phase I studies, their administrative processes are generally performed independently, and their timelines driven by different priorities: safety reviews, clinical operations, regulatory submissions, and contracting of clinical delivery vendors for industry; contracts, budgets, and institutional review board approval for academia. Both processes converge on US Food and Drug Administration approval of an IND. In the context of a strategic alliance between M. D. Anderson Cancer Center and AstraZeneca Pharmaceuticals LP, a concerted effort has been made to eliminate delays in implementing clinical trials. These efforts focused on close communications, identifying and matching key timelines, alignment of priorities, and tackling administrative processes in parallel, rather than sequentially. In a recent, first-in-human trial, the study was activated and the first patient identified in 46 days from completion of the final study protocol and about 48 hours after final US Food and Drug Administration IND approval, reducing the overall timeline by about 3 months, while meeting all clinical good practice guidelines. Eliminating administrative delays can accelerate the evaluation of new drugs without compromising patient safety or the quality of clinical research.
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Gonsenhauser, Blair, Rose Hallarn, Daniel Carpenter, Michael F. Para, and Carson R. Reider. "StudySearch: a web-based application for posting and searching clinical research studies." Journal of Investigative Medicine 64, no. 3 (2016): 786–90. http://dx.doi.org/10.1136/jim-2015-000021.
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Participant accrual into research studies is critical to advancing clinical and translational research to clinical care. Without sufficient recruitment, the purpose of any research study cannot be realized; yet, low recruitment and enrollment of participants persist. StudySearch is a web-based application designed to provide an easily readable, publicly accessible, and searchable listing of IRB-approved protocols that are accruing study participants. The Regulatory, Recruitment and Biomedical Informatics Cores of the Center for Clinical and Translational Science (CCTS) at The Ohio State University developed this research study posting platform. Postings include basic descriptive information: study title, purpose of the study, eligibility criteria and study personnel contact information. Language concerning benefits and/or inducements is not included; therefore, while IRB approval for a study to be listed on StudySearch is required, IRB approval of the posted language is not. Studies are listed by one of two methods; one automated and one manual: (1). Studies registered on ClinicalTrials.gov are automatically downloaded once a month; or (2). Studies are submitted directly by researchers to the CCTS Regulatory Core staff. In either case, final language is a result of an iterative process between researchers and CCTS staff. Deployed in January 2011 at OSU, this application has grown to approximately 200 studies currently posted and 1500 unique visitors per month. Locally, StudySearch is part of the CCTS recruitment toolkit. Features continue to be modified to better accommodate user behaviors. Nationally, this open source application is available for use.
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McJoynt, Terre A., Muhanad A. Hirzallah, Daniel V. Satele, Jason H. Pitzen, Steven R. Alberts, and S. Vincent Rajkumar. "Building a Protocol Expressway: The Case of Mayo Clinic Cancer Center." Journal of Clinical Oncology 27, no. 23 (2009): 3855–60. http://dx.doi.org/10.1200/jco.2008.21.4338.
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Purpose Inconsistencies and errors resulting from nonstandard processes, together with redundancies, rework, and excess workload, lead to extended time frames for clinical trial protocol development. This results in dissatisfaction among sponsors, investigators, and staff and restricts the availability of novel treatment options for patients. Methods A team of experts from Mayo Clinic formed, including Protocol Development Unit staff and management from the three Mayo Clinic campuses (Florida, Minnesota, and Arizona), a systems and procedures analyst, a quality office analyst, and two physician members to address the identified deficiencies. The current-state process was intensively reviewed, and improvement steps were taken to accelerate the development and approval of cancer-related clinical trials. The primary goal was to decrease the time from receipt of a new protocol through submission to an approving authority, such as the National Cancer Institute or institutional review board. Results Using the Define, Measure, Analyze, Improve, Control (DMAIC) framework infused with Lean waste-reduction methodologies, areas were identified for improvement, including enhancing first-time quality and processing new studies on a first-in/first-out basis. The project was successful in improving the mean turnaround time for internally authored protocols (P < .001) from 25.00 weeks (n = 41; range, 3.43 to 94.14 weeks) to 10.15 weeks (n = 14; range, 4.00 to 22.14 weeks). The mean turnaround time for externally authored protocols was improved (P < .001) from 20.61 weeks (n = 85; range, 3.29 to 108.57 weeks) to 7.79 weeks (n = 50; range, 2.00 to 20.86 weeks). Conclusion DMAIC framework combined with Lean methodologies is an effective tool to structure the definition, planning, analysis, and implementation of significant process changes.
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Lyngstadaas, Anita. "STATUS AND POTENTIAL OF GENE THERAPY IN CLINICAL MEDICINE." International Journal of Technology Assessment in Health Care 18, no. 3 (2002): 645–74. http://dx.doi.org/10.1017/s026646230200048x.
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Objective: Somatic gene therapy is a new method in the rapidly expanding field of molecular medicine. Due to recent encouraging results and the promising prospect for some disease groups, Norwegian health authorities wanted to assess somatic therapy with evidence-based standards for strategic use. This article presents the results of this assessment, discussed in the context of the policy-making process in Norway, including ethical and legislational considerations.Methods: Clinical gene therapy protocols, ongoing or completed with published results, where available, were identified through a systematic survey of descriptive protocols and publications. Preclinical literature was also reviewed.Results: Gene therapy is dominated by preclinical and clinical research. Most of the gene therapy protocols identified are in early phases (phases I and II) with only a few patients in each study. Of the protocols included in the assessment, only three phase III studies are represented. Except for the use of soluble antisense oligonucleotides against cytomegalovirus eye infection, gene therapy is presently not an established treatment modality. Promising results have been observed in treatment of cancer and cardiovascular diseases and, most recently, in inherited severe combined immunodeficiency and hemophilia. Several interesting principles addressing a large panel of conditions are currently being developed and tested.Conclusions: Gene therapy is developing into an important medical concept that needs to be included within the Norwegian healthcare system. It is recommended that the Norwegian Ministry of Health and Social Affairs fund a national program to boost infrastructure in selected scientific groups both in preclinical and clinical research. The national procedures regulating approval of gene therapy trials should be made more efficient while at the same time allowing for proper control and ethical considerations. It is emphasized that gene therapy trials should be carefully monitored for side effects.
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Ortega, Rafael, Rafael Dal-Ré, and Rafael Dal-Re. "Clinical Trials Committees: How Long Is the Protocol Review and Approval Process in Spain? A Prospective Study." IRB: Ethics and Human Research 17, no. 4 (1995): 6. http://dx.doi.org/10.2307/3564154.
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Brodowicz, T., I. Steiner, S. Beslija, et al. "Time interval between final protocol approval (FPA) and inclusion of the first patient into randomized clinical trials (RCTs) performed by the Central European Cooperative Oncology Group (CECOG): A 10-year experience." Journal of Clinical Oncology 27, no. 15_suppl (2009): 6546. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.6546.
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6546 Background: CECOG has been formed in 1999 to unite centers of clinical oncology from Central and Southeastern Europe and Israel in order to conduct and coordinate multicenter oncology RCTs. Based on the European legislation passed in 2001 (Directive 2001/20/EC), clinical trials must get ethical approval and approval from the competent authorities (CA). However, the duration of these regulatory procedures to initiate a clinical trial is a factor determining the competitive position in clinical research. Methods: Within the last 10 years, CECOG conducted trials in breast, colorectal, esophago-gastric, NSCLC, pancreatic, prostate cancer and GIST. We analyzed the dates of FPA, the approvals by Ethics Review Boards (ERB) and CAs, the letters of agreement between sponsor and site (LoA), the site initiation and the inclusion of the first patient in a total of 6 multicenter trials in 25 CECOG study centers in Austria, Bosnia, Bulgaria, Croatia, the Czech Republic, Hungary, Israel, Poland, Romania, Serbia, and Slovakia. Results: The average time interval from FPA to the inclusion of the first patient was 18.4 ± 9.4 months. Most of this time has been spent for regulatory procedures, i.e. the approval by ERBs (9.6 ± 7.2 months) and CAs (10.0 ± 6.6 months). The LoA were signed 11.5 ± 9.4 months after FPA. The time interval from approval by the CAs to site initiation was 3.3 ± 3.7 months and the interval between site initiation and the inclusion of the first patient was 4.2 ± 4.5 months. Conclusions: The ‘paper to patient process‘ - the time interval between the approval of the final study protocol and the inclusion of the first patient - required 18.4 months on average in 6 multicenter trials conducted by CECOG. As the regulatory procedures used up more than 50% of duration of the whole process, optimization is necessary and realistic in order to make novel therapies available to patients more quickly. No significant financial relationships to disclose.
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Sequeira, Lydia, Gillian Strudwick, Sharon M. Bailey, Vincenzo De Luca, David Wiljer, and John Strauss. "Factors influencing suicide risk assessment clinical practice: protocol for a scoping review." BMJ Open 9, no. 2 (2019): e026566. http://dx.doi.org/10.1136/bmjopen-2018-026566.
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IntroductionEvery year, suicide accounts for nearly 800 000 deaths worldwide. Appropriate risk assessment and intervention are imperative since evidence demonstrates that a large proportion of those who die by suicide visit health professionals prior to their death. Much previous research has focused on identifying patient-level risk factors that can improve the risk assessment process through scales and algorithms. However, the best practice guidelines emphasise the importance of clinical interviews and prioritise the clinician’s final judgement. The purpose of this review is to (1) understand the clinician and organisational level barriers and facilitators that influence a clinician’s assessment of suicide risk, (2) identify the types of biases that exist within this process and (3) list any evidence-based training protocols and educational initiatives to aid (or support) clinicians with this process.Methods and analysisThis scoping review protocol uses the Arksey and O’Malley framework, and Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines for scoping reviews. Literature will be identified using a multidatabase search strategy developed in consultation with a medical librarian. The proposed screening process consists of a title and abstract scan, followed by a full-text review by two reviewers to determine the eligibility of articles. Studies outlining any factors that affect a clinician’s suicide risk assessment process, ranging from individual experience and behaviours to organisational level influences, will be included. A tabular synthesis of the general study details will be provided, as well as a narrative synthesis of the extracted data, organised into themes using the Situated Clinical Decision-Making framework.Ethics and disseminationEthical approval is not required for this review. Results will be translated into educational materials and presentations for dissemination to appropriate knowledge users. Knowledge outputs will also include academic presentations at relevant conferences, and a published, peer-reviewed journal article.
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Dilts, David M., and Alan B. Sandler. "Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials." Journal of Clinical Oncology 24, no. 28 (2006): 4545–52. http://dx.doi.org/10.1200/jco.2005.05.0104.
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Purpose To investigate the administrative barriers that impact the opening of clinical trials at the Vanderbilt-Ingram Cancer Center (VICC) and at VICC Affiliate Network (VICCAN) sites. Methods VICC, a National Cancer Institute–designated comprehensive cancer center, and three VICCAN community practice sites were studied. Methodology used was identification and mapping of existing processes and analysis of historical timing data. Results At course granularity, the process steps required at VICC and VICCAN main office plus local sites are 20 v 17 to 30 steps, respectively; this gap widens with finer granularity, with more than 110 v less than 60 steps, respectively. Approximately 50% of the steps are nonvalue added. For example, in the institutional review board (IRB) process, less than one third of the steps add value to the final protocol. The numbers of groups involved in the approval processes are 27 (VICC) and 6 to 14 (VICCAN home office and local sites). The median times to open a trial are 171 days (95% CI, 158 to 182 days) for VICC and 191 days (95% CI, 119 to 269 days) for the VICCAN sites. Contrary to expectations, the time for IRB review and approval (median, 47 days) is the fastest process compared with the scientific review committee review and approval (median, 70 days) and contracts and grants review (median, 78.5 days). Opening a cooperative group clinical trial is significantly (P = .05) more rapid because they require fewer review steps. Conclusion There are numerous opportunities to remove nonvalue-added steps and save time in opening clinical trials. With increasing numbers of new agents, fewer domestic principal investigators, and more companies off-shoring clinical trials, overcoming such barriers is of critical importance for maintenance of core oncology research capabilities in the United States.
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Martin, Michelle T., Elena Telebak, Paige A. Taylor, and Olga Volozhina. "Development of a specialty medication prior-authorization service at an urban academic medical center." American Journal of Health-System Pharmacy 73, no. 15 (2016): 1174–79. http://dx.doi.org/10.2146/ajhp160059.
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Abstract Purpose The project in which a clinical pharmacist enlisted the help of pharmacy students to create a team responsible for prior-authorization (PA) paperwork associated with hepatitis C virus (HCV) infection treatment is described. Summary Many insurance companies require completion of a time-consuming PA process for approval of high-cost specialty medications, such as those used in the treatment of HCV infection. A clinical pharmacist at an urban academic medical center recruited pharmacy students to assist with and streamline the HCV medication PA process. After training, the students developed a protocol to increase the efficiency of completing PA requests, appealing denials, obtaining PA extensions, and documenting progress in the electronic medical record to ensure continuity of care. The PA team collaborated with clinicians to document proof of medical need and worked with insurers, pharmacies, and patients to achieve timely approval and receipt of medications. From June 2014 to March 2015, three students spent 240 hours developing the PA protocol and completing 88 PA requests, with an overall medication approval rate of 87.7%; 18 patients were also referred to medication assistance programs. The PA team’s work allowed the clinical pharmacist to spend more time on clinical activities and scholarship, while the students increased their knowledge of HCV disease and HCV-targeted therapies and improved their skills in written and verbal communication with patients, providers, and insurance companies. Conclusion Pharmacy students successfully implemented a PA team to manage prescription approval for HCV medications with assistance from a clinical pharmacist.
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Mandi, Henshaw, Solomon Abebe Yimer, and Gunnstein Norheim. "Mapping time use in clinical trials for vaccines against emerging infectious diseases." Clinical Trials 18, no. 3 (2021): 286–94. http://dx.doi.org/10.1177/1740774520977283.
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Background: Vaccines are potent tools to prevent outbreaks of emerging infectious diseases from becoming epidemics and need to be developed at an accelerated pace to have any impact on the course of an ongoing epidemic. The aim of this study was to describe time use in the execution of vaccine trials, to identify steps that could be accelerated to improve preparedness and planning for future emerging infectious diseases vaccine trials. Methods: We used a mixed-methods approach to map time use and process steps that could be accelerated during vaccine trials. Trials for vaccines against infectious diseases registered in three global trial databases reported in the period 2011–2017 were eligible to join the survey. We invited sponsors to contribute data through a predefined structured questionnaire for clinical trial process metrics. Data were stratified by trial phase, disease type (i.e. emerging infectious diseases or not emerging infectious diseases), sponsor type, and continent. Qualitative interviews were conducted with purposively selected sponsors, and thematic analysis of the interview transcripts was performed. Results: Based on data from 155 vaccine trials including 29,071 subjects, 52% were phase I, 23% phase II, and 25% phase III. We found that the regulatory approval, subject enrollment, study execution, and study close-out accounted for most of the cycle time of the vaccine trial process. Cycle times for the regulatory and ethical approvals, contract agreement, site initiation, and study execution were shorter in trials conducted during outbreaks. Qualitative interviews indicated that early engagement of the regulatory and independent ethical committee authorities in planning the vaccine trials was critical for saving time in trial approval. Furthermore, adapting the trial implementation to the reality of the study sites and active involvement of the local investigators during the planning of the trial and protocol writing were stated to be of paramount importance to successful completion of trials at an accelerated pace. Conclusion: The regulatory approval, subject recruitment, study execution, and close-out cycle times accounted for most of the vaccine trial time use and are activities that could be accelerated during a vaccine trial planning and implementation. We encourage tracking of key cycle time metrics and facilitating sharing of knowledge across industry and academia, as this may serve to reduce the time from index case detection to access of a vaccine during emerging infectious diseases epidemics.
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Bampoe, Sohail, Tim Cook, Lee Fleisher, et al. "Clinical indicators for reporting the effectiveness of patient quality and safety-related interventions: a protocol of a systematic review and Delphi consensus process as part of the international Standardised Endpoints for Perioperative Medicine initiative (StEP)." BMJ Open 8, no. 11 (2018): e023427. http://dx.doi.org/10.1136/bmjopen-2018-023427.
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IntroductionClinical indicators are used to measure and quantify the safety and quality of patient care. They are also often used as endpoints in clinical trials. Definitions of clinical indicators in common use are extremely heterogeneous, limiting their applicability. As part of the international Standardised Endpoints in Perioperative Medicine initiative, this study will identify clinical indicators by systematically reviewing the anaesthesia and perioperative medicine literature, and will provide consensus, clinically useful definitions for those indicators using a Delphi process.Methods and analysisAn electronic database search will be conducted of Medline (PubMed/OVID), EMBASE and the Cochrane Library in order to meet this review’s objectives that are: (1) To identify clinical indicators and their definitions used in randomised controlled trials that assess patient-related quality and safety interventions in perioperative medicine; (2) To select a shortlist of recommended indicators and definitions that are the most suitable for evaluation of quality and safety interventions following an expert-based consensus-gaining process (Delphi method) and (3) To provide a classification scale for each indicator related to its clarity of definition, validity (strength), reliability, feasibility (ease of use) and frequency of use. This systematic review protocol is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidance.Ethics and disseminationEthical approval is not required for this systematic review and Delphi process. The results of this study will be disseminated to the anaesthesia and perioperative medicine clinical and academic community through national and international presentations and through publication in a peer reviewed journal.PROSPERO registration numberCRD42016042102.
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Williams, Erin, Timothy J. Brown, Patrice Griffith, et al. "Improving the Time to Activation of New Clinical Trials at a National Cancer Institute–Designated Comprehensive Cancer Center." JCO Oncology Practice 16, no. 4 (2020): e324-e332. http://dx.doi.org/10.1200/op.19.00325.
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PURPOSE: The time it takes a performing site to activate a clinical trial can directly affect the ability to provide innovative and state-of-the-art care to patients. We sought to understand the process of activating an oncology clinical trial at a matrix National Cancer Institute–designated comprehensive cancer center. METHODS: A multidisciplinary team of stakeholders within the cancer center, university, and affiliate hospitals held a retreat to map out the process of activating a clinical trial. We applied classical quality improvement and Six Sigma methodology to determine bottlenecks and non–value-added time in activating a clinical trial. During this process, attention was paid to time to pass through each step, and perceived barriers and bottlenecks were identified through group discussions. RESULTS: The process map identified 66 steps with 12 decision points to activate a new clinical trial. The following two steps were instituted first: allow parallel scientific committee and institutional review board (IRB) review and allow the clinical research coordination committee, a group that determines university interest and feasibility, to review protocols independent of the IRB and scientific committee approval. The clinical research coordination committee continues to track the activation time, and this framework is used to identify additional improvement steps. CONCLUSION: By applying quality improvement methodologies and Six Sigma principles, we were able to identify redundancies in the process to activate a clinical trial. This allowed us to redesign the process of activating a clinical trial at a matrix comprehensive cancer center. More importantly, the process map provides a framework to maintain these gains and implement additional changes and serves as an example to deploy across the campus and at other similar institutions.
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Briggs, Raymond P., and Lois Ramer. "Elements of a clinical trial protocol for medical devices." Journal of Nursing Education and Practice 7, no. 6 (2017): 65. http://dx.doi.org/10.5430/jnep.v7n6p65.
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Based on a Class 2 limited risk hospital based clinical trial, and a subsequent project retrospective, Briggs and Ramer propose an expanded clinical trial protocol. Such an expanded protocol would be especially helpful for evaluating De Novo devices: new inventions which require new processes for full hospital integration. Since these new processes would often require training of nurses and supporting professionals, Briggs and Ramer suggest that nurse investigators could be very effective in carrying out such expanded protocol studies. We briefly describe the FDA approval process, the role of the nurse in evidence based medical device evaluation, the Ramer, et al. clinical trial, the proposed expanded clinical trial protocol, and candidate categories of devices that might employ the limited risk Class 2 Medical Device clinical trial protocol. The investigators look forward to carrying out such a medical device clinical trial in the near future.
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Wiles, Louise K., Peter D. Hibbert, Jacqueline H. Stephens, et al. "STANDING Collaboration: a study protocol for developing clinical standards." BMJ Open 7, no. 10 (2017): e014048. http://dx.doi.org/10.1136/bmjopen-2016-014048.
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IntroductionDespite widespread availability of clinical practice guidelines (CPGs), considerable gaps continue between the care that is recommended (‘appropriate care’) and the care provided. Problems with current CPGs are commonly cited as barriers to providing ’appropriate care'.Our study aims to develop and test an alternative method to keep CPGs accessible and up to date. This method aims to mitigate existing problems by using a single process to develop clinical standards (embodied in clinical indicators) collaboratively with researchers, healthcare professionals, patients and consumers. A transparent and inclusive online curated (purpose-designed, custom-built, wiki-type) system will use an ongoing and iterative documentation process to facilitate synthesis of up-to-date information and make available its provenance. All participants are required to declare conflicts of interest. This protocol describes three phases: engagement of relevant stakeholders; design of a process to develop clinical standards (embodied in indicators) for ‘appropriate care’ for common medical conditions; and evaluation of our processes, products and feasibility.Methods and analysisA modified e-Delphi process will be used to gain consensus on ‘appropriate care’ for a range of common medical conditions. Clinical standards and indicators will be developed through searches of national and international guidelines, and formulated with explicit criteria for inclusion, exclusion, time frame and setting. Healthcare professionals and consumers will review the indicators via the wiki-based modified e-Delphi process. Reviewers will declare conflicts of interest which will be recorded and managed according to an established protocol. The provenance of all indicators and suggestions included or excluded will be logged from indicator inception to finalisation. A mixed-methods formative evaluation of our research methodology will be undertaken.Ethics and disseminationHuman Research Ethics Committee approval has been received from the University of South Australia. We will submit the results of the study to relevant journals and offer national and international presentations.
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Caruso, Rebecca, Theodore Myatt, and Barbara E. Bierer. "Innovation in biosafety oversight: The Harvard Catalyst Common Reciprocal IBC Reliance Authorization Agreement." Journal of Clinical and Translational Science 4, no. 2 (2020): 90–95. http://dx.doi.org/10.1017/cts.2019.405.
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AbstractIncreasingly, basic, translational, and clinical research has become more collaborative, resulting in multi-institutional studies that involve common approaches to a central question. For multi-institutional projects that involve recombinant or synthetic nucleic acids, Institutional Biosafety Committee (IBC) review is generally required at each separate site. Duplicative review may result in both administrative costs and delays, without evidence of increased safety or protections, and investigator frustration. To address these inefficiencies, IBC leaders drafted a collaborative IBC Reliance Authorization Agreement. The Agreement allows one or more institutions to cede IBC review to a reviewing IBC that accepts the responsibility. The ability to cede IBC review, and the ability to rely on one decision on behalf of all collaborating institutions for a given protocol, removes delays in approval of multi-center protocols, and collaborating principal investigators are able to focus on research rather than administrative tasks. In the process, we found promotion of this collaborative model led to stronger connections among institutions and among IBC members. The requirement for IBC member representation from the local community, however, limits its broader dissemination; we make several recommendations to mitigate this challenge.
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Ward, Richard A., Jörg Vienken, Douglas M. Silverstein, Stephen Ash, and Bernard Canaud. "Regulatory Considerations for Hemodiafiltration in the United States." Clinical Journal of the American Society of Nephrology 13, no. 9 (2018): 1444–49. http://dx.doi.org/10.2215/cjn.12641117.
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Online hemodiafiltration provides greater removal of higher molecular weight uremic retention solutes than conventional high-flux hemodialysis. However, online hemodiafiltration is used sparsely in the United States in part because of a paucity of delivery systems cleared for clinical use by the US Food and Drug Administration. Although a pathway for regulatory approval exists in the United States, concerns remain, particularly regarding online production of the large volumes of sterile, nonpyrogenic substitution fluid infused directly into the bloodstream to maintain fluid balance. Clearly defined testing protocols, acceptable to Food and Drug Administration, will be useful to show that an online hemodiafiltration system is capable of routinely achieving a sterility assurance level of 10−6 and nonpyrogenic levels of endotoxin. Large-scale clinical experience has shown that systems providing this level of performance when combined with certain design features, such as redundancy, and an appropriate quality management process can routinely and safely produce substitution fluid for online hemodiafiltration.
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Martínez García, Laura, Hector Pardo-Hernandez, Ena Niño de Guzman, et al. "Development of a prioritisation tool for the updating of clinical guideline questions: the UpPriority Tool protocol." BMJ Open 7, no. 8 (2017): e017226. http://dx.doi.org/10.1136/bmjopen-2017-017226.
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IntroductionDue to a continuous emergence of new evidence, clinical guidelines (CGs) require regular surveillance of evidence to maintain their trustworthiness. The updating of CGs is resource intensive and time consuming; therefore, updating may include a prioritisation process to efficiently ensure recommendations remain up to date. The objective of our project is to develop a pragmatic tool to prioritise clinical questions for updating within a CG.Methods and analysisTo develop the tool, we will use the results and conclusions of a systematic review of methodological research on prioritisation processes for updating and will adopt a methodological approach we have successfully implemented in a previous experience.We will perform a multistep process including (1) generation of an initial version of the tool, (2) optimisation of the tool (feasibility test of the tool, semistructured interviews, Delphi consensus survey, external review by CG methodologists and users and pilot test of the tool) and (3) approval of the final version of the tool.At each step of the process, we will (1) calculate absolute frequencies and proportions (quantitative data), (2) use content analysis to summarise and draw conclusions (qualitative data) and (3) draft a final report, discuss results and refine the previous versions of the tool. Finally, we will calculate intraclass coefficients with 95% CIs for each item and overall as indicators of agreement among reviewers.Ethics and disseminationWe have obtained a waiver of approval from the Clinical Research Ethics Committee at the Hospital de la Santa Creu i Sant Pau (Barcelona). The results of the study will be published in peer-reviewed journal and communicated to interested stakeholders.The tool could support the standardisation of prioritisation processes for updating CGs and therefore have important implications for a more efficient use of resources in the CG field.
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McCrone, Daniel, Dudley W. Gill, Cecilia Tran, and Jessica Flocco. "Improving Medical Oncology Quality Through Peer-to-Peer Consultation." Journal of Oncology Practice 10, no. 2 (2014): 105–6. http://dx.doi.org/10.1200/jop.2013.001107.
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Purpose: This study describes how the use of peer-to-peer (P2P) physician consultation improves medical oncology care quality by preventing non–evidence-based and potentially morbid chemotherapy treatments. New Century Health (NCH) has adapted a physician audit and feedback model to strengthen adherence to clinical guidelines. In the NCH oncology program, P2P consultation complements clinical pathways and an online prior authorization platform. Payers are adopting the use of clinical pathways as a management strategy for managing costs and improving quality. Managing medical oncology is a complex process, because evidence evolves rapidly, and almost one third of chemotherapy is prescribed off label. The use of prior authorization, combined with standardized protocols for patients with specific cancer diagnoses, is one way for payers to reduce unnecessary treatment variation. [Table: see text] Methods: NCH completed a retrospective analysis of the chemotherapy treatment requests (CTRs) submitted by payers' oncologists for prior authorization between January and December 2012. The objectives of the clinical impact analysis were to measure the CTR disposition rate, identify the CTR intervention rate resulting from P2P consultation, and identify the types of drug triggering the interventions. Results: Analysis of the 13,078 CTRs associated with the 1,116 unique Medicare and commercial patients of a national health plan determined that CTRs voluntarily withdrawn or recommended adverse determination (RAD; ie, NCH recommendation to member's health plan to not authorize treatment as requested; after review of health plan policy and compendia, NCH was not able to resolve provider's request through P2P consultation and could not recommend approval of treatment plan as requested, therefore recommending denial of request) by the submitting physician as a result of a P2P consultation with an NCH board-certified oncologist comprised 11.6% of all CTRs. Further analysis identified the types of medication associated with the 1,521 CTRs withdrawn/RAD as a consequence of P2P consultation. Interventions on chemotherapeutic medications and supportive care were evenly distributed at 51.2% and 48.8%, respectively. Interventions on medications that had received US Food and Drug Administration approval within the last 2 years (initial approval or for new indications) represented 12.1%. [Table: see text] Conclusion: Using P2P consultation to complement a pathway-driven prior authorization process improves medical oncology quality. In addition, P2P consultation can be an effective collaborative physician engagement strategy by supporting oncologists with critical clinical information and mitigating concerns about pathway implementation and about payer involvement in drug use management.
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Brown, Timothy J., Erin Fenske Williams, Patrice Griffith, et al. "Applying quality improvement methodologies to decrease the time-to-activation of new clinical trials at an NCI-designated comprehensive cancer center." Journal of Clinical Oncology 37, no. 27_suppl (2019): 296. http://dx.doi.org/10.1200/jco.2019.37.27_suppl.296.
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296 Background: Initiating a new clinical trial is burdensome and complex. The time to activate a clinical trial can directly affect the ability to provide innovative, state-of-the-art care to patients. We sought to understand the process of activating an oncology clinical trial at a matrix National Cancer Institute-designated, comprehensive cancer center. Methods: A multidisciplinary team of stakeholders within the cancer center, university, and affiliate hospitals held a retreat to map out the process of activating a clinical trial from packet receipt to enrollment of the first patient. We applied classical QI and Six Sigma methodology to determine bottlenecks and redundancies in activating a clinical trial. During this process, particular attention was paid to time to pass through each step and perceived barriers and bottlenecks were identified through group discussions. The time to activation was measured from the day the trial packet was received until the time when the trial was open for enrollment. Results: The process map identified 66 steps with 12 decision points to activate a new clinical trial. The following two steps were instituted first: 1) allow parallel scientific committee and institutional review board (IRB) review and 2) allow the clinical research coordination committee to review protocols for feasibility and university interest separate from the IRB approval process. These changes resulted in a mean time-to-activation change from 194 days at baseline to 135 days after these changes were implemented. The committee continues to track the activation time and this frame work is used to identify additional improvement steps. Conclusions: By applying quality improvement methodologies and Six Sigma principles, we were able to redesign redundant aspects of the process of activating a clinical trial at a matrix comprehensive cancer center. This was associated with a reduction of time to activation of trials. More importantly, the process map provides a framework to maintain these gains and implement further changes.
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Fraser, Justin F., Lisa A. Collier, Amy A. Gorman, et al. "The Blood And Clot Thrombectomy Registry And Collaboration (BACTRAC) protocol: novel method for evaluating human stroke." Journal of NeuroInterventional Surgery 11, no. 3 (2018): 265–70. http://dx.doi.org/10.1136/neurintsurg-2018-014118.
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BackgroundIschemic stroke research faces difficulties in translating pathology between animal models and human patients to develop treatments. Mechanical thrombectomy, for the first time, offers a momentary window into the changes occurring in ischemia. We developed a tissue banking protocol to capture intracranial thrombi and the blood immediately proximal and distal to it.ObjectiveTo develop and share a reproducible protocol to bank these specimens for future analysis.MethodsWe established a protocol approved by the institutional review board for tissue processing during thrombectomy (www.clinicaltrials.govNCT03153683). The protocol was a joint clinical/basic science effort among multiple laboratories and the NeuroInterventional Radiology service line. We constructed a workspace in the angiography suite, and developed a step-by-step process for specimen retrieval and processing.ResultsOur protocol successfully yielded samples for analysis in all but one case. In our preliminary dataset, the process produced adequate amounts of tissue from distal blood, proximal blood, and thrombi for gene expression and proteomics analyses. We describe the tissue banking protocol, and highlight training protocols and mechanics of on-call research staffing. In addition, preliminary integrity analyses demonstrated high-quality yields for RNA and protein.ConclusionsWe have developed a novel tissue banking protocol using mechanical thrombectomy to capture thrombus along with arterial blood proximal and distal to it. The protocol provides high-quality specimens, facilitating analysis of the initial molecular response to ischemic stroke in the human condition for the first time. This approach will permit reverse translation to animal models for treatment development.
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Zingariello, Carla D., John Brandsema, Elizabeth Drum, et al. "A multidisciplinary approach to dosing nusinersen for spinal muscular atrophy." Neurology: Clinical Practice 9, no. 5 (2019): 424–32. http://dx.doi.org/10.1212/cpj.0000000000000718.
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BackgroundIn December 2016, nusinersen gained FDA approval as the first pharmacologic treatment for spinal muscular atrophy (SMA), a disorder of motor neurons and the leading genetic cause of infant mortality. Nusinersen's intrathecal delivery requirement, strict dosage protocol, and accelerated FDA approval presented a challenge to health care centers hoping to implement treatment of patients with SMA. Scheduling logistics, combined with the specific ventilatory, anesthetic, and spinal access needs of this patient population, requires extensive coordination of care. This complexity, in addition to the high cost of treatment, may lead to overburdening of an institution's dosing resources, causing delays in treatment initiation and limiting patients' access to therapy and may result in barriers to coverage.MethodsWe initiated a comprehensive stepwise protocol to maximize patient inclusion, as well as safety and efficiency outcome measures. This retrospective cohort study reviews the dosing process.ResultsAs a result of immense collaborative efforts involving care coordination of patients and families, in addition to health providers in the divisions of neurology, anesthesiology, pulmonology, orthopedics, interventional radiology, physical therapy, and neurosurgery, we have successfully dosed 62 SMA patients. Throughout this process, we have improved anesthetic techniques, as well as minimized procedural complications and missed scheduled doses.ConclusionWe present here recommendations for safe and effective implementation of nusinersen utilizing a multidisciplinary approach, based on our 1 and a half year experience at a tertiary care children's hospital.
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Larkin, Louise, Tala Raad, Anusha Moses, et al. "The impact of COVID-19 on clinical research: the PIPPRA and MEDRA experience." HRB Open Research 4 (May 18, 2021): 55. http://dx.doi.org/10.12688/hrbopenres.13283.1.
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Background: Coronavirus disease 2019 (COVID-19) has had a significant impact on clinical research. This paper aims to provide an insight into how the COVID-19 pandemic, associated public health restrictions and international guidance on the conduct of clinical research impacted two clinical rheumatology research trials - the Physiotherapist-led Intervention to Promote Physical Activity in Rheumatoid Arthritis (PIPPRA) and the MEDiterranean diet in Rheumatoid Arthritis (MEDRA) projects. Methods: The March 2019 public health restrictions imposed to mitigate the risk of COVID-19 occurred at a time when PIPPRA was in the process of delivering assessment and intervention on a face-to-face basis (n=48) and MEDRA had commenced recruitment. Participants in PIPPRA and MEDRA had a diagnosis of rheumatoid arthritis, with some being immunosuppressed and thus at a higher risk for COVID-19. The decision-making processes of both trials is outlined to demonstrate the required amendments to continue in the context of the COVID-19 pandemic. Results: Amendments to PIPPRA and MEDRA trial protocols were agreed and received ethical and funder approval. Both trials switched from a face-to-face delivery to a telehealth using online platforms. The PIPPRA study was paused for five months (April-August 2020), resulting in n=33 (60%) deviations from assessment protocol. MEDRA switched from face-to-face to online recruitment with 20% (n=35/44) deviation in recruitment. Of the n=18 participants who consented to participating in a face-to-face trial, just n=2 (11%) opted to engage with telehealth delivery of the intervention. MEDRA assessment and intervention deviations were 100% as no sessions were completed as planned in 2020. Conclusions: The COVID-19 pandemic has severely impacted the PIPPRA and MEDRA clinical trials. Moving face-to-face clinical research to telehealth delivery may not be the panacea it is purported to be. Our experiences may be of benefit to researchers, clinicians, and funders in seeking to continue clinical research during a global pandemic.
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Swanson, J. M., M. Lerner, T. Wigal, et al. "The use of a laboratory school protocol to evaluate concepts about efficacy and side effects of new formulations of stimulant medications." Journal of Attention Disorders 6, no. 1_suppl (2002): 73–88. http://dx.doi.org/10.1177/070674370200601s10.
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Recently, new long-acting formulations of racemic methylphenidate (MPH: Ritalin® LA, Metadate® CD and Concerta®) and amphetamine (AMP: Adderall XR®) were developed and are now approved by the Food and Drug Administration (FDA). In addition, dexmethylphenidate (Focalin ™), the pharmacologically active d-threo enantiomer of MPH, also was approved by the FDA. In the initial phases of development, prototypes of these five new formulations were evaluated using the University of California, Irvine (UCI) Laboratory School Protocol (LSP), in which surrogate measures of efficacy are collected in highly controlled settings rather than clinical measures of effectiveness in the less-controlled, natural environments of home or school. The LSP studies were followed by large effectiveness and safety studies required for gaining FDA approval. These initial efficacy and side effect studies in the LSP provided missing information about the basic pharmacokinetic (PK) and pharmacodynamic (PD) properties of MPH and AMP and produced some new discoveries (i.e., acute tolerance) that were used to help design the final products. The final once-a-day formulations used different drug delivery systems to achieve long-acting efficacy (Ritalin® LA, Metadate® CD, Concerta®, Adderall XR®). All four drug delivery systems were based on two processes: first, a bolus delivery (BD) process to achieve rapid onset of efficacy (mg), and second, a controlled delivery (CD) process to achieve rates of delivery (mg/hr) or a delayed bolus (mg) to maintain efficacy. A theoretical approach was used to compare and contrast the new once-a day formulations of MPH by selecting total daily doses (mg/d) that would equate drug delivery by the first process (mg of the Initial bolus) and the second process (mg/hr over specified time period). In addition to efficacy, applications of the LSP to measure common side effects related to eating and sleeping were described and discussed.
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Heriot, Natalie, Alison Brand, Paul Cohen, et al. "Developing an Australian multi-module clinical quality registry for gynaecological cancers: a protocol paper." BMJ Open 10, no. 2 (2020): e034579. http://dx.doi.org/10.1136/bmjopen-2019-034579.
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IntroductionGynaecological cancers collectively account for almost 10% of cancer diagnoses made in Australian women. The extent of variation in gynaecological cancer survival rates and treatment outcomes across Australia is not well documented. The purpose of the clinical quality registry described in this paper is to systematically monitor and improve quality of care provided to these women, and facilitate clinical process improvements to ensure better patient outcomes and greater adherence to best practice care. The registry infrastructure has been developed in conjunction alongside the inaugural ovarian, tubal and peritoneal (OTP) module, allowing for concurrent piloting of the methodology and one module. Additional tumour modules will be developed in time to cover the other gynaecological tumour types.Method and analysisThe National Gynae-Oncology Registry (NGOR) aims to capture clinical data on all newly diagnosed cancers of the uterus, ovary, fallopian tubes, peritoneum, cervix, vulva and vagina in Australia with a view to using these data to support improved clinical care and increased adherence to ‘best practice’. Data are sourced from existing clinical databases maintained by clinicians and/or hospital gynaecological cancer units. A pilot phase incorporating only OTP cancers has recently been conducted to assess the feasibility of the registry methodology and assess the support of a quality initiative of this nature among clinicians and other key stakeholders.Ethics and disseminationThe NGOR has received National Mutual Acceptance (NMA) ethics approval from Monash Health Human Research Ethics Committee (HREC), NMA HREC Reference Number: HREC/17/MonH/198. We also have approval from Mercy Health HREC and University of Tasmania HREC. Data will be routinely reported back to participating sites illustrating their performance against measures of agreed best practice. It is through this feedback system that the registry will support changes to quality of care and improved patient outcomes.
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Dixon, Dennis O., Susanna Weiss, Kelly Cahill, et al. "Data and safety monitoring policy for National Institute of Allergy and Infectious Diseases clinical trials." Clinical Trials 8, no. 6 (2011): 727–35. http://dx.doi.org/10.1177/1740774511425181.
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Background Historically, four divisions of the National Institute of Allergy and Infectious Diseases (NIAID) that manage clinical trials and oversee data and safety monitoring have operated fairly autonomously with respect to their approaches to Data and Safety Monitoring Board (DSMB) operations. We recognized the need for a revised policy on DSMB operations in an effort to encourage greater harmonization of procedures across the four divisions. Purpose The purpose of this article is to describe the considerations that motivated the development of the new policy, summarize current DSMB policies and ongoing harmonization efforts across the four divisions, and offer some recommendations for DSMB operations in the hope that other organizations may benefit from our experience. Methods From 2005 to 2009, a working group undertook a review of DSMB responsibilities, policies, and operations. We analyzed and summarized the final policy document that the working group produced, gathered data describing current DSMB activities, and developed a tabular, cross-sectional overview highlighting how divisions are harmonizing their DSMB operations. Results In 2010, there were 44 DSMBs in NIAID monitoring 169 protocols, and those DSMBs conducted 209 reviews of the protocols. Review and analysis of DSMB practices across the four divisions have led to recommendations for efficient and successful DSMB operations: adopt an inclusive approach, whereby the trial investigators assist in the process of forming and utilizing DSMBs; structures other than DSMBs can often provide many of the features of DSMBs but with greater flexibility in membership, access to interim data, and scheduling; the trial protocol should specify what safety and other concerns should trigger a DSMB review and what data should be included in prespecified reviews; present data in thoughtful and user-friendly ways that answer specific questions; allow sufficient time to plan for working with the DSMB. Limitations We recognize that NIAID’s specific circumstances and DSMB policy may not apply to the operation of DSMBs in every organization. Nevertheless, we believe that useful lessons can be learned from our experiences and efforts toward harmonization. Conclusions Homogeneity in DSMB operations and management has appeal as a matter of organizational policy and efficiency. Some limited flexibility, as long as it honors fundamental principles of independence, confidentiality of interim trial results, and clear lines of reporting and approval, may be appropriate on occasion. NIAID’s 2009 institute-level policy established a collective understanding of the important contribution that DSMBs make to the responsible conduct of clinical trials. Thinking will continue to evolve, leading to further policy refinements and the continued assurance of patient safety in our clinical trials.
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Kearns, Jamie, Aisling M. Ross, Darragh R. Walsh, et al. "A blood biomarker and clinical correlation cohort study protocol to diagnose sports-related concussion and monitor recovery in elite rugby." BMJ Open Sport & Exercise Medicine 6, no. 1 (2020): e000948. http://dx.doi.org/10.1136/bmjsem-2020-000948.
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IntroductionIn professional rugby, sports-related concussion (SRC) remains the most frequent time loss injury. Therefore, accurately diagnosing SRC and monitoring player recovery, through a multi-modal assessment process, is critical to SRC management. In this protocol study, we aim to assess SRC over multiple time points post-injury to determine the value of multi-modal assessments to monitor player recovery. This is of significance to minimise premature return-to-play and, ultimately, to reduce the long-term effects associated with SRC. The study will also establish the logistics of implementing such a study in a professional setting to monitor a player’s SRC recovery.Methods and analysisAll players from the participating professional rugby club within the Irish Rugby Football Union are invited to participate in the current study. Player assessment includes head injury assessment (HIA), neuropsychometric assessment (ImPACT), targeted biomarker analysis and untargeted biomarker analysis. Baseline HIA, ImPACT, and blood draws are performed prior to the start of playing season. During the baseline tests, player’s complete consent forms and an SRC history questionnaire. Subsequently, any participant that enters the HIA process over the playing season due to a suspected SRC will be clinically assessed (HIA and ImPACT) and their blood will be drawn within 3 days of injury, 6 days post-injury, and 13 days post-injury.Ethics and disseminationEthical approval was attained from the Science and Engineering Research Ethics Committee, University of Limerick (Approval Code: 2018_06_11_S&E). On completion of the study, further manuscripts will be published to present the results of the tests and their ability to measure player recovery from SRC.Trial registration numberNCT04485494.
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Nabukenya, Sylvia, Barbara Castelnuovo, Andrew Kambugu, et al. "PP122 Strengthening Ethics Compliance In A Large Research Program: Uganda." International Journal of Technology Assessment in Health Care 33, S1 (2017): 129. http://dx.doi.org/10.1017/s0266462317002781.
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INTRODUCTION:The infectious Diseases Institute (IDI) is a research institute at the College of Health Sciences, Makerere University. Over the years, the number of research studies has greatly increased with an average of fifty active studies per year. Because of the voluminous study activities, investigators were faced with inadvertences of ethical approval deadlines (1). In 2015, a centralized electronic Regulatory Affairs Information System (RAIS) was developed and piloted to track the regulatory process of the entire research projects. RAIS is a web-based system, developed using a Net framework and runs on any operating system using a web browser such as “Google Chrome” and “Mozilla Firefox”.METHODS:A signed approval letter from an accredited Research Ethics Committee, National Drug Authority and Uganda National Council of Science and Technology, the reviewed protocol, consent forms and data collection tools are uploaded electronically into the RAIS with study staff contact information, CVs and Good Clinical Practice (GCP) certificates. RAIS sends automatic “no reply” emails to the investigators and research administration notifying for the need of annual renewal 56, 28 and 14 days before the expiry date of the approvals. The investigator or designated person prepares the application package which is then forwarded to the Research Regulatory Officer for review and submission to the regulatory authority.RESULTS:From January 2015 to November 2016, fourty-three ongoing studies were uploaded to the RAIS of which eleven were clinical trials, twenty-one observational studies, seven diagnostic and four implementation studies. Studies that obtained their annual approvals before the expiry date was 90.7 percent, compared to 29 percent that had reported early submission for annual renewal between January 2013 and December 2014. RAIS has enabled continuity of study activities with timely annual renewed approvals, supported the tracking of staff GCP certificates and populated timely notifications to investigators, resulting in submission of annual application packages on time.CONCLUSIONS:RAIS has strengthened ethical regulatory compliance and provided an effective platform for tracking regulatory processes, thus enabled continuity of study activities with timely annual renewal approvals and greatly supported the tracking of staff GCP certificates.
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Grossman, S. A., S. Piantadosi, and C. Covahey. "Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families?" Journal of Clinical Oncology 12, no. 10 (1994): 2211–15. http://dx.doi.org/10.1200/jco.1994.12.10.2211.
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PURPOSE This study was conducted to assess the readability of informed consent forms that describe clinical oncology protocols. METHODS One hundred thirty-seven consent forms from 88 protocols that accrued patients at The Johns Hopkins Oncology Center were quantitatively analyzed. These included 58 of 99 (59%) institutional protocols approved by The Johns Hopkins Oncology Center's Clinical Research Committee and the Institutional Review Board (IRB) over a 2-year period, and 30 active Eastern Cooperative Oncology Group (ECOG), Radiation Therapy Oncology Group (RTOG), and Pediatric Oncology Group (POG) trials. The consent forms described phase I (17%), phase I/II (36%), phase III (29%), and nontherapeutic (18%) studies. Each was optically scanned, checked for accuracy, and analyzed using readability software. The following three readability indices were obtained for each consent form: the Flesch Reading Ease Score, and grade level readability as determined by the Flesch-Kincaid Formula and the Gunning Fog Index. RESULTS The mean +/- SD Flesch Reading Ease Score for the consent forms was 52.6 +/- 8.7 (range, 33 to 78). The mean grade level was 11.1 +/- 1.67 (range, 6 to 14) using the Flesch-Kincaid Formula and 14.1 +/- 1.8 (range, 8 to 17) using the Gunning Fog Index. Readability at or below an eighth-grade level was found in 6% of the consent forms using the Flesch-Kincaid Formula and in 1% using the Gunning Fog Index. Readability was similar for consent forms that described institutional, cooperative group, and phase I, II, and III protocols. CONCLUSION Consent forms from clinical oncology protocols are written at a level that is difficult for most patients to read, despite national, cooperative group, institutional, and departmental review. The consent process, which is crucial to clinical research, should be strengthened by improving the readability of the consent forms.
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Wong, Ambrose H., Jessica M. Ray, Marc A. Auerbach, et al. "Study protocol for the ACT response pilot intervention: development, implementation and evaluation of a systems-based Agitation Code Team (ACT) in the emergency department." BMJ Open 10, no. 6 (2020): e036982. http://dx.doi.org/10.1136/bmjopen-2020-036982.
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IntroductionEmergency department (ED) visits for behavioural conditions are rising, with 1.7 million associated episodes of patient agitation occurring annually in acute care settings. When de-escalation techniques fail during agitation management, patients are subject to use of physical restraints and sedatives, which are associated with up to 37% risk of hypotension, apnoea and physical injuries. At the same time, ED staff report workplace violence due to physical assaults during agitation events. We recently developed a theoretical framework to characterise ED agitation, which identified teamwork as a critical component to reduce harm. Currently, no structured team response protocol for ED agitation addressing both patient and staff safety exists.Methods and analysisOur proposed study aims to develop and implement the agitation code team (ACT) response intervention, which will consist of a standardised, structured process with defined health worker roles/responsibilities, work processes and clinical protocols. First, we will develop the ACT response intervention in a two-step design loop; conceptual design will engage users in the creation of the prototype, and iterative refinement will occur through in situ simulated agitated patient encounters in the ED to assess and improve the design. Next, we will pilot the intervention in the clinical environment and use a controlled interrupted time series design to evaluate its effect on our primary outcome of patient restraint use. The intervention will be considered efficacious if we effectively lower the rate of restraint use over a 6-month period.Ethics and disseminationEthical approval by the Yale University Human Investigation Committee was obtained in 2019 (HIC #2000025113). Results will be disseminated through peer-reviewed publications and presentations at scientific meetings for each phase of the study. If this pilot is successful, we plan to formally integrate the ACT response intervention into clinical workflows at all EDs within our entire health system.
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Lillis, Steven, and Hayley Lord. "Repeat prescribing reducing errors." Journal of Primary Health Care 3, no. 2 (2011): 153. http://dx.doi.org/10.1071/hc11153.
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BACKGROUND AND CONTEXT: Prescribing errors account for a significant proportion of overall error in general practice. Repeat prescribing occurs commonly in New Zealand and is a likely cause of error in practice. ASSESSMENT OF PROBLEM: This paper reports on two related aspects of repeat prescribing; an audit of adherence to a repeat prescribing protocol and self-reported repeat prescribing incidents in a network of 97 general practices. RESULTS: The audit of adherence to the repeat prescribing protocol revealed that some issues persist. In particular, prescribing medication outside an approved list and exceeding specified time limits or maximal scripts before clinical review were problematic. Repeat prescribing encompassed a range of departures of process from minor (such as prescription not available on time) to major (wrong medication). Corrective measures highlighted the importance of both the pharmacist and the patient in error detection. STRATEGIES FOR IMPROVEMENT: Repeat prescribing needs to be recognised as a process potentially fraught with error. Effective practice systems, patient involvement and enhanced pharmacy communication are important contributing factors in reducing error. LESSONS: There is need for robust data regarding error rates in prescribing and the impact of changing prescribing protocols on error rates. KEYWORDS: Medication errors; electronic prescribing
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Rollins, Barrett J., Laura E. MacConaill, Nikhil Wagle, et al. "PROFILE: Broadly based genomic testing for all patients at a major cancer center." Journal of Clinical Oncology 31, no. 15_suppl (2013): 1531. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.1531.
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1531 Background: Genotyping plays an increasingly important role in the management of cancer patients. However, the landscape of genomic abnormalities is unknown for many cancers and the influence of specific genotypes on clinical behavior is often unclear. To address these deficiencies, we developed PROFILE, a project designed to obtain genomic information on all patients who come to our hospitals for cancer-related care. Methods: Clinically acquired specimens were genotyped using a mass spectrometry genotyping test (OncoMap) which assays 471 alleles in 41 cancer-related genes. Because the majority of these alleles currently have no known clinical meaning, we implemented PROFILE as a research test. This required developing an "umbrella" protocol governing PROFILE activity, a highly simplified 2-page consenting brochure, and a centralized consenting process. We created process flows for retrieving clinical specimens and performing OncoMap in a CLIA-certified laboratory. We return results on individual participants to their ordering providers who can use actionable findings to guide management. All results are stored in a database which can be queried using a web-based search tool that returns aggregate results. Approval to link specimen to clinical information can be sought by a streamlined process of User Committee and IRB approval, and linkage is performed by IS acting as honest brokers. Results: From August 2011 through December 2012, we consented 12,980 patients (consent rate >70%). We found that 39% of clinical samples are of sufficient quality to yield OncoMap results. We have reported and stored 3,000 genotyping results. OncoMap mutations were detected in 40% of clinical samples. As expected, mutations in KRAS, PIK3CA, TP53, and BRAF were most commonly observed across all tumor types. However, rarer mutations were also detected in RET, PIK3R1, and ERBB2 among others. Conclusions: Novel operational approaches have permitted enterprise-wide, broadly-based genotyping that serves a combination of research and clinical needs. Early insights from this database will be discussed along with information about their impact on clinical management.
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Song, Yang, Andrea Darzi, Monica Ballesteros, et al. "Extending the RIGHT statement for reporting adapted practice guidelines in healthcare: the RIGHT-Ad@pt Checklist protocol." BMJ Open 9, no. 9 (2019): e031767. http://dx.doi.org/10.1136/bmjopen-2019-031767.
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IntroductionThe adaptation of guidelines is an increasingly used methodology for the efficient development of contextualised recommendations. Nevertheless, there is no specific reporting guidance. The essential Reporting Items of Practice Guidelines in Healthcare (RIGHT) statement could be useful for reporting adapted guidelines, but it does not address all the important aspects of the adaptation process. The objective of our project is to develop an extension of the RIGHT statement for the reporting of adapted guidelines (RIGHT-Ad@pt Checklist).Methods and analysisTo develop the RIGHT-Ad@pt Checklist, we will use a multistep process that includes: (1) establishment of a Working Group; (2) generation of an initial checklist based on the RIGHT statement; (3) optimisation of the checklist (an initial assessment of adapted guidelines, semistructured interviews, a Delphi consensus survey, an external review by guideline developers and users and a final assessment of adapted guidelines); and (4) approval of the final checklist. At each step of the process, we will calculate absolute frequencies and proportions, use content analysis to summarise and draw conclusions, discuss the results, draft a report and refine the checklist.Ethics and disseminationWe have obtained a waiver of approval from the Clinical Research Ethics Committee at the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain). We will disseminate the RIGHT-Ad@pt Checklist by publishing into a peer-reviewed journal, presenting to relevant stakeholders and translating into different languages. We will continuously seek feedback from stakeholders, surveil new relevant evidence and, if necessary, update the checklist.
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Shanthosh, Janani, Deksha Kapoor, Lakshmi K. Josyula, et al. "Lifestyle InterVention IN Gestational diabetes (LIVING) in India, Bangladesh and Sri Lanka: protocol for process evaluation of a randomised controlled trial." BMJ Open 10, no. 12 (2020): e037774. http://dx.doi.org/10.1136/bmjopen-2020-037774.
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IntroductionThe development of type 2 diabetes mellitus disproportionately affects South Asian women with prior gestational diabetes mellitus (GDM). The Lifestyle InterVention IN Gestational diabetes (LIVING) Study is a randomised controlled trial of a low-intensity lifestyle modification programme tailored to women with previous GDM, in India, Bangladesh and Sri Lanka, aimed at preventing diabetes/pre-diabetes. The aim of this process evaluation is to understand what worked, and why, during the LIVING intervention implementation, and to provide additional data that will assist in the interpretation of the LIVING Study results. The findings will also inform future scale-up efforts if the intervention is found to be effective.Methods and analysisThe Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) methodological approach informed the evaluation framework. Michie’s Behaviour Change Theory and Normalisation Process Theory were used to guide the design of our qualitative evaluation tools within the overall RE-AIM evaluation framework. Mixed methods including qualitative interviews, focus groups and quantitative analyses will be used to evaluate the intervention from the perspectives of the women receiving the intervention, facilitators, site investigators and project management staff. The evaluation will use evaluation datasets, administratively collected process data accessed during monitoring visits, check lists and logs, quantitative participant evaluation surveys, semistructured interviews and focus group discussions. Interview participants will be recruited using maximum variation purposive sampling. We will undertake thematic analysis of all qualitative data, conducted contemporaneously with data collection until thematic saturation has been achieved. To triangulate data, the analysis team will engage in constant iterative comparison among data from various stakeholders.Ethics and disseminationEthics approval has been obtained from the respective human research ethics committees of the All India Institute of Medical Sciences, New Delhi, India; University of Sydney, New South Wales, Australia; and site-specific approval at each local site in the three countries: India, Bangladesh and Sri Lanka. This includes approvals from the Institutional Ethics Committee at King Edwards Memorial Hospital, Maharaja Agrasen Hospital, Centre for Disease Control New Delhi, Goa Medical College, Jawaharlal Institute of Postgraduate Medical Education and Research, Madras Diabetes Research Foundation, Christian Medical College Vellore, Fernandez Hospital Foundation, Castle Street Hospital for Women, University of Kelaniya, Topiwala National Medical College and BYL Nair Charitable Hospital, Birdem General Hospital and the International Centre for Diarrhoeal Disease Research. Findings will be documented in academic publications, presentations at scientific meetings and stakeholder workshops.Trial registration numbersClinical Trials Registry of India (CTRI/2017/06/008744); Sri Lanka Clinical Trials Registry (SLCTR/2017/001) and ClinicalTrials.gov Registry (NCT03305939); Pre-results.
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Gutierrez-Sanchez, Daniel, Marina García-Gámez, Juan Pablo Leiva-Santos, and Inmaculada Lopez-Leiva. "Instruments for assessing health professionals’ skills in breaking bad news: protocol for a systematic review of measurement properties." BMJ Open 11, no. 8 (2021): e048019. http://dx.doi.org/10.1136/bmjopen-2020-048019.
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IntroductionHealth professionals are often involved in the process of breaking bad news (BBN), which remains a difficult challenge, as it requires not only theoretical knowledge, but also the development of humanistic, emotional and communication skills. Therefore, optimal BBN assessment is essential. In this regard, sound measurement instruments are needed to evaluate BBN properly in research, teaching and clinical settings. Several instruments have been designed and validated to assess BBN. In this context, choosing the most appropriate instrument for assessing health professionals’ skills in BBN is essential. The aims of this systematic review are to: (1) identify all the instruments used for assessing health professionals’ skills in BBN; and (2) critically appraise their measurement properties.MethodsA systematic review will be undertaken according to the most up-to-date COnsensus-based Standards for the selection of health status Measurement INstruments’ (COSMIN) methodology. The protocol of this systematic review was developed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search strategy will be performed following the Peer Review of Electronic Search Strategies. The search strategy will be conducted in CINAHL, MEDLINE, Embase, PsycINFO, SciELO and Open Grey. Two review authors will independently appraise the full-text articles according to the COSMIN Risk of Bias checklist. Quality ratings and evidence synthesis will be performed using a modified Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationEthical approval is not necessary for systematic review protocols. The results will be disseminated by publication in a peer-reviewed journal and presented at a relevant conference.PROSPERO registration numberCRD42020207586.
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Parry, Monica, Abida Dhukai, Hance Clarke, et al. "Development and usability testing of HEARTPA♀N: protocol for a mixed methods strategy to develop an integrated smartphone and web-based intervention for women with cardiac pain." BMJ Open 10, no. 3 (2020): e033092. http://dx.doi.org/10.1136/bmjopen-2019-033092.
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IntroductionMore women experience cardiac pain related to coronary artery disease and cardiac procedures compared with men. The overall goal of this programme of research is to develop an integrated smartphone and web-based intervention (HEARTPA♀N) to help women recognise and self-manage cardiac pain.Methods and analysisThis protocol outlines the mixed methods strategy used for the development of the HEARTPA♀N content/core feature set (phase 2A), usability testing (phase 2B) and evaluation with a pilot randomised controlled trial (RCT) (phase 3). We are using the individual and family self-management theory, mobile device functionality and pervasive information architecture of mHealth interventions, and following a sequential phased approach recommended by the Medical Research Council to develop HEARTPA♀N. The phase 3 pilot RCT will enable us to refine the prototype, inform the methodology and calculate the sample size for a larger multisite RCT (phase 4, future work). Patient partners have been actively involved in setting the HEARTPA♀N research agenda, including defining patient-reported outcome measures for the pilot RCT: pain and health-related quality of life (HRQoL). As such, the guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols (SPIRIT-PRO) are used to report the protocol for the pilot RCT (phase 3). Quantitative data (eg, demographic and clinical information) will be summarised using descriptive statistics (phases 2AB and 3) and a content analysis will be used to identify themes (phase 2AB). A process evaluation will be used to assess the feasibility of the implementation of the intervention and a preliminary efficacy evaluation will be undertaken focusing on the outcomes of pain and HRQoL (phase 3).Ethics and disseminationEthics approval was obtained from the University of Toronto (36415; 26 November 2018). We will disseminate knowledge of HEARTPA♀N through publication, conference presentation and national public forums (Café Scientifique), and through fact sheets, tweets and webinars.Trial registration numberNCT03800082.
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Heinbokel, Christina, Marco Lehmann, Nadine Janis Pohontsch, et al. "Diagnostic barriers for somatic symptom disorders in primary care: study protocol for a mixed methods study in Germany." BMJ Open 7, no. 8 (2017): e014157. http://dx.doi.org/10.1136/bmjopen-2016-014157.
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IntroductionSomatoform or somatic symptom disorders ((S)SD) are common and have a negative impact on the patients’ health-related quality of life, healthcare use and costs. In primary care, which is central to the management of (S)SD, diagnosis and treatment tend to be delayed. There is a significant lack of evidence regarding the barriers in the diagnostic process of (S)SD in primary care and how interventions should be tailored to address them. The aim of this study is to analyse the diagnostic process in primary care that results in the diagnosis or non-diagnosis of a (S)SD.Methods and analysisThis mixed methods study will investigate the topic with qualitative methods, subsequently proceeding to a quantitative phase where the initial results will be validated and/or generalised. First, focus groups will explore meanings and patterns, inconsistencies and conflicts in general practitioners’ (GPs) thoughts and behaviours when diagnosing (S)SD. Second, the results of these focus groups will be used to develop interview guidelines for subsequent face-to-face interviews. Patients and their treating GPs will be interviewed separately on how they experience the history of illness, the diagnostic process and treatment. Third, based on the results of the first two study parts, a questionnaire will be derived and a nationwide survey among German GPs will be conducted, quantifying the barriers and difficulties identified before.Ethics and disseminationEthics approval was obtained from the Ethics Committee of the Hamburg Medical Association, Germany (approval number PV4763). The results of this study will be disseminated through conference presentation and publications in peer-reviewed journals.Trial registration numberThe study is registered in the German Clinical Trial Register (DRKS), DRKS-ID DRKS00009736.