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Wear, Sandra M., Paul G. Richardson, Carolyn Revta, et al. "The Multiple Myeloma Research Consortium (MMRC): Accelerated Start up and Accrual Metrics Speeds Drug Development." Blood 118, no. 21 (2011): 1024. http://dx.doi.org/10.1182/blood.v118.21.1024.1024.
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Abstract Abstract 1024 Background: The MMRC is a non-profit, disease-focused consortium founded in 2004. Sixteen North American member institutions with expertise in multiple myeloma (MM) work collaboratively with the MMRC Inc. (Norwalk, CT) and numerous pharmaceutical partners to speed development of new treatment options to MM patients. In December 2007, MMRC Inc. implemented business solutions to address barriers to rapid activation of phase I-II trials and established benchmarks for initiating and conducting these studies. In December 2010, we reported significantly faster trial start up and accrual data from previous years1,2. Today, we update and expand on MMRC performance data and analysis of progress. Methods: Twenty-five (25) trials conducted within the Consortium from May 2006 to July 2011 had sufficient start up trial data for review. FPFD was defined as the time from the member institutions' receipt of the final protocol (FP) from the trial sponsor, to the time the first patient was dosed on the trial at any participating MMRC member institution. With respect to enrollment, pre-study enrollment commitment (EC) established between MMRC and the study sponsor was defined as the total number of subjects committed to receive at least one dose of study drug across all participating MMRC centers on a trial; baseline enrollment timeline (BET) was prospectively defined as the target time period to attain EC. Results: Mean time to FPFD in the recent group of trials (RG; n=18; Sept 08-Jul 11) held steady at 131 calendar days from receipt of FP as compared to 181 days for the early group of trials (EG; n=7; Jun06-Sept08) representing a 28% reduction in time to FPFD. More importantly, there was a 20% decrease in time to FPFD by all participating MMRC centers on any MMRC trial from 189 days in the RG compared to 236 days in the EG representing an important achievement especially in the Phase I/II arena. MMRC trial accrual data was available for 17/25 trials (2 EG trials were missing data and 6 RG trials continue enrolling). The pre-study mean MMRC EC was 44 subjects per trial (n=19 trials; 849 patients); the mean actual MMRC enrollment was 49 subjects per trial (n=19; 935 patients through July 11) representing a 10% over enrollment versus committed enrollment. A total of 17/19 evaluable trials (89%) met their EC; 12/19 trials met EC within BET (71%) of which 8/12 trials (67%) reached EC 34% faster than their BET (representing a mean reduction of 4.5 months). The overall pre-study mean BET for 19 trials was 13.6 months. MMRC's actual mean enrollment timeline was 12.8 months for the group of 17 evaluable trials representing improvement over the original BET by a mean of 10%. Discussion: MMRC's acceleration of clinical trials provides physicians and patients with rapid access to novel compounds; industry with data for important drug development decisions; and academic institutions with more trials of high scientific interest. Even so, our data uncovered opportunities for improvement. The submission time from receipt of the final protocol from the trial sponsor to Scientific Review Committee (SRC) took an average 30 calendar days across all trials. A reduction to half this time could make a difference to patients and therefore warrants further exploration. Conclusion: Today, drug development in multiple myeloma is fast-paced and highly competitive. MMRC's frequent review of trial metrics provides valuable insight to continually speed answers to physicians, patients and industry. Disclosures: Richardson: Multiple Myeloma Research Consortium: Annual grant in support Clinical Trial Project Management. Vij:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Lonial:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Siegel:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Jakubowiak:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Reece:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Jagannath:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Hofmeister:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Stewart:Multiple Myeloma Research Consortium: Annual Grant in support of clinical trial Project Management. Wolf:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Krishnan:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Zimmerman:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Kumar:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Roy:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Fay:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management. Anderson:Multiple Myeloma Research Consortium: Annual grant in support of clinical trial Project Management.
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Meeker-O’Connell, Ann, Ansalan Stewart, and Coleen Glessner. "Can quality management drive evidence generation?" Clinical Trials 19, no. 1 (2021): 112–15. http://dx.doi.org/10.1177/17407745211034496.
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Recent guidance documents from international regulators emphasize the importance of thoughtful trial design and risk-based oversight in delivering reliable results. In practice, these recommendations are often implemented in a fragmented manner, reducing their effectiveness. We argue that collaborative, cross-stakeholder engagement that prioritizes both optimal trial design and tailored oversight are a necessary and effective approach to modernize quality management. This practice is at the core of Quality by Design, an approach that involves identifying important errors that could undermine trial credibility or participant safety and addressing them proactively. While Quality by Design is well suited for clinical trials supporting regulatory approval of a new medicinal product, we describe how the approach is equally relevant for pragmatic trials, including those conducted in the context of a pandemic.
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Ogden, John, Hao Xie, Wen Ma, and Joleen Hubbard. "The Management of Older Adults with Pancreatic Adenocarcinoma." Geriatrics 3, no. 4 (2018): 85. http://dx.doi.org/10.3390/geriatrics3040085.
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Pancreatic cancer is the eleventh most common cancer, yet it is the third leading cause of mortality. It is also largely a disease of older adults, with the median age of 71 at diagnosis in the US, with <1% of diagnoses occurring prior to age 50. Current NCCN guidelines recommend surgery for localized disease, followed by adjuvant therapy and/or consideration of enrollment in a clinical trial. For metastatic disease, current guidelines recommend clinical trial enrollment or systemic chemotherapy based on results from the landmark ACCORD-11 and MPACT trials. However, these trials focused heavily on younger, more fit patients, with the ACCORD-11 trial excluding patients over age 75 and the MPACT trial having 92% of its patients with a Karnofsky performance score >80. This article summarizes the available evidence in current literature in regards to the best treatment options for older adults, who represent the majority of pancreatic cancer diagnoses.
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Cashing, Maureen. "Pain Management On Trial." AJN, American Journal of Nursing 92, no. 2 (1992): 21–22. http://dx.doi.org/10.1097/00000446-199202000-00016.
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Farrell, Barbara. "Trial (management) and error." Lancet 393, no. 10184 (2019): 1935–36. http://dx.doi.org/10.1016/s0140-6736(19)30029-7.
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Taylor, Nick, and Judge Roderick Denyer. "Judicial Management of Juror Impropriety." Journal of Criminal Law 78, no. 1 (2014): 43–64. http://dx.doi.org/10.1350/jcla.2014.78.1.891.
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The debate surrounding the utility of trial by jury is as relevant as ever. Much criticism of the ability of jurors to carry out their task was brought to the fore following the highly publicised Pryce trial and the comments from Sweeney J indicating a fundamental problem in jurors' understanding of their role. Furthermore, media attention surrounding a steady stream of cases involving juror misconduct has called into question whether jury trial can survive in its current form. This article recognises that although juries are not a normative part of a fair trial, they do have considerable value in enhancing public confidence in the fairness of the criminal process, particularly through the perception of impartiality. If public support is lost, then the value of jury might be lost with it. Whilst the Law Commission is rightly considering how jurors might be more prepared in advance to carry out their role effectively, this article considers the current judicial approach to dealing with the practical issue of juror impropriety once it has occurred. Through looking at a series of trial and appeal cases it can be seen that a framework has developed which seeks to ensure that trials are derailed rarely whilst the impartiality of the jury is safeguarded. It is maintained that in emphasising both actual and apparent impartiality the vital element of public confidence in the existing process can be preserved.
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Vautrin, M., G. Kaminski, B. Barimani, et al. "Does candidate for plate fixation selection improve the functional outcome after midshaft clavicle fracture? A systematic review of 1348 patients." Shoulder & Elbow 11, no. 1 (2018): 9–16. http://dx.doi.org/10.1177/1758573218777996.
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Introduction The hypothesis of this study was that patient selection for midshaft clavicle fracture (open reduction internal fixation with plate versus conservative) would give better functional outcome than random treatment allocation. Methods We performed a systematic literature search for primary studies providing functional score and non-union rate after conservative or surgical management of midshaft clavicle fractures. Six randomized controlled trial and 19 non-randomized controlled trial studies encompassing a total of 1348 patients were included. Results Patients treated with surgical management were found to have statistically superior Constant scores in non-randomized controlled trials than in randomized controlled trials (94.76 ± 6.4 versus 92.49 ± 6.2; p < 0.0001). For conservative treatment, randomized controlled trials were found to have significantly better functional outcome. The prevalence of non-union (6.1%) did not show significant statistical difference between non-randomized controlled trial and randomized controlled trial studies. The functional outcome after surgical management was significantly higher than after conservative management in both randomized controlled trial and non-randomized controlled trial groups. The non-union rate after surgery (1.1% for both non-randomized controlled trial and randomized controlled trial) was significantly lower than following conservative treatment (9.9% non-randomized controlled trial versus 15.1% randomized controlled trial). Discussion This review shows that patient selection for surgery may influence functional outcome after midshaft clavicle fracture. Our results also confirm that plate fixation provides better functional outcome and lower non-union rate.
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Alam, Mehnaaz, D. Yamini Sai Nikitha, Sai Sugun Jala, and Gulam Khaleel Ahmed. "Archival and management of clinical trial documents." International Journal of Clinical Trials 8, no. 1 (2021): 101. http://dx.doi.org/10.18203/2349-3259.ijct20210150.
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<p class="abstract">Clinical trial documents are all records, in any type which incorporates written, electronic, magnetic, optical records, scans, x-rays and electrocardiograms that describe or record the strategy, conduct and results of an effort, the factors poignant an effort and the actions taken. Such a record is thought as document and method is documentation. The documents collected before, throughout and once clinical trials give proof that the study was conducted, the information collected is correct and valid which the investigator and sponsor conducted the trial in line with ICH GCP tips is thought as Trial master file. because of exaggerated quality of studies, particularly medical specialty studies, and therefore the issue managing paper TMF’s for various departments, most organizations have moved to eTMF. Archiving may be a key demand to guage post trial observance and analysis and to facilitate any analysis before initiation of an effort and deposit strategy should be developed. It includes the subsequent parts documents to be archived, amount of archiving, location, retrieval or access of archived documents, disaster recovery, procedure of clinical knowledge archiving, archiving by an ethics committee, archiving by the investigator. Archiving of trial documents helps to store knowledge safely and firmly for future use with facilities like secure systems and e-back up.</p>
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Mudaranthakam, Dinesh Pal, Alexandra Brown, Elizabeth Kerling, Susan E. Carlson, Christina J. Valentine, and Byron Gajewski. "The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study." JMIR Formative Research 5, no. 12 (2021): e30368. http://dx.doi.org/10.2196/30368.
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Background As the cost of clinical trials continues to rise, novel approaches are required to ensure ethical allocation of resources. Multisite trials have been increasingly utilized in phase 1 trials for rare diseases and in phase 2 and 3 trials to meet accrual needs. The benefits of multisite trials include easier patient recruitment, expanded generalizability, and more robust statistical analyses. However, there are several problems more likely to arise in multisite trials, including accrual inequality, protocol nonadherence, data entry mistakes, and data integration difficulties. Objective The Biostatistics & Data Science department at the University of Kansas Medical Center developed a clinical trial management system (comprehensive research information system [CRIS]) specifically designed to streamline multisite clinical trial management. Methods A National Institute of Child Health and Human Development–funded phase 3 trial, the ADORE (assessment of docosahexaenoic acid [DHA] on reducing early preterm birth) trial fully utilized CRIS to provide automated accrual reports, centralize data capture, automate trial completion reports, and streamline data harmonization. Results Using the ADORE trial as an example, we describe the utility of CRIS in database design, regulatory compliance, training standardization, study management, and automated reporting. Our goal is to continue to build a CRIS through use in subsequent multisite trials. Reports generated to suit the needs of future studies will be available as templates. Conclusions The implementation of similar tools and systems could provide significant cost-saving and operational benefit to multisite trials. Trial Registration ClinicalTrials.gov NCT02626299; https://tinyurl.com/j6erphcj
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Pung, Johannes, and Otto Rienhoff. "Key components and IT assistance of participant management in clinical research: a scoping review." JAMIA Open 3, no. 3 (2020): 449–58. http://dx.doi.org/10.1093/jamiaopen/ooaa041.
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Abstract Objectives Managing participants and their data are fundamental for the success of a clinical trial. Our review identifies and describes processes that deal with management of trial participants and highlights information technology (IT) assistance for clinical research in the context of participant management. Methods A scoping literature review design, based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement, was used to identify literature on trial participant-related proceedings, work procedures, or workflows, and assisting electronic systems. Results The literature search identified 1329 articles of which 111 were included for analysis. Participant-related procedures were categorized into 4 major trial processes: recruitment, obtaining informed consent, managing identities, and managing administrative data. Our results demonstrated that management of trial participants is considered in nearly every step of clinical trials, and that IT was successfully introduced to all participant-related areas of a clinical trial to facilitate processes. Discussion There is no precise definition of participant management, so a broad search strategy was necessary, resulting in a high number of articles that had to be excluded. Nevertheless, this review provides a comprehensive overview of participant management-related components, which was lacking so far. The review contributes to a better understanding of how computer-assisted management of participants in clinical trials is possible.
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Vodovozov, Aleksey. "Clinical trials in the Coronavirus era: management of risks." Remedium Journal about the Russian market of medicines and medical equipment, no. 11-12 (2020): 18–24. http://dx.doi.org/10.21518/1561-5936-2020-11-12-18-24.
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The COVID-19 pandemic has caused unique problems facing the clinical trials (CT) community both in terms of the rapid implementation of CTs of COVID-19 drugs and vaccines, and many ongoing non-COVID-19 CTs that are either suspended or adapted to new realities. The CT organizers have played a key role in decision making, risk assessment and adaptation of trial processes, working side by side with other members of the trial team. Regulatory authorities (FDA, EMA, Ministry of Health of Russia, etc.), which issued initial recommendations for adapting the clinical trial methodology to new conditions as far back as March 2020, and then later on, generalized the experience in the management for clinical trials. The recommendations made based on the reviewed experience can help all CT parties to cope with the risks associated with both COVID-19 itself and anti-epidemic measures in different countries of the world with minimal losses.
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Fu, Zhiying, Min Jiang, Kun Wang, and Jian Li. "Minimizing the Impact of the COVID-19 Epidemic on Oncology Clinical Trials: Retrospective Study of Beijing Cancer Hospital." Journal of Medical Internet Research 23, no. 3 (2021): e26799. http://dx.doi.org/10.2196/26799.
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Background In view of repeated COVID-19 outbreaks in most countries, clinical trials will continue to be conducted under outbreak prevention and control measures for the next few years. It is very significant to explore an optimal clinical trial management model during the outbreak period to provide reference and insight for other clinical trial centers worldwide. Objective The aim of this study was to explore the management strategies used to minimize the impact of the COVID-19 epidemic on oncology clinical trials. Methods We implemented a remote management model to maintain clinical trials conducted at Beijing Cancer Hospital, which realized remote project approval, remote initiation, remote visits, remote administration and remote monitoring to get through two COVID-19 outbreaks in the capital city from February to April and June to July 2020. The effectiveness of measures was evaluated as differences in rates of protocol compliance, participants lost to follow-up, participant withdrawal, disease progression, participant mortality, and detection of monitoring problems. Results During the late of the first outbreak, modifications were made in trial processing, participant management and quality control, which allowed the hospital to ensure the smooth conduct of 572 trials, with a protocol compliance rate of 85.24% for 3718 participants across both outbreaks. No COVID-19 infections were recorded among participants or trial staff, and no major procedural errors occurred between February and July 2020. These measures led to significantly higher rates of protocol compliance and significantly lower rates of loss to follow-up or withdrawal after the second outbreak than after the first, without affecting rates of disease progression or mortality. The hospital provided trial sponsors with a remote monitoring system in a timely manner, and 3820 trial issues were identified. Conclusions When public health emergencies occur, an optimal clinical trial model combining on-site and remote management could guarantee the health care and treatment needs of clinical trial participants, in which remote management plays a key role.
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IJSMI, Editor. "An overview of clinical trial data management, its standards and recent trends." International Journal of Statistics and Medical Informatics 5, no. 1 (2017): 1–6. https://doi.org/10.5281/zenodo.1038417.
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Clinical trials help pharmaceutical/biomedical organisations to bring the drug/treatment/procedure from the development stage to the end user stage. Normally clinical trials consists of four stages Phase I – IV. During the Phase-III which involves human beings as the subject of trial, requires significant amount of data to be captured, cleaned, transformed, compiled, audited, analysed and reported. Traditional data management techniques may not be sufficient to manage the current clinical trials as they are conducted at different location results in high cost of collecting, storing and processing of data. Hence there is need for advanced technologies such as online/web based data management techniques to increase the efficiency in collecting, storing and processing of data and also to reduce the cost related to the clinical trial data. This paper starts with a brief overview of clinical trials, regulatory requirement, guidelines, and its different phases. It further discusses the traditional tools, techniques and standards to handle clinical trials data, software available for clinical trial data management and recent trends.
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Joshi, Trupti Amol, Amol Kalyanrao Joshi, and Laxmikant Sheshrao Deshmukh. "Prebiotics in Management of Neonatal Jaundice: Open Label Randomised Control Trial." Asian Journal of Clinical Pediatrics and Neonatology 7, no. 4 (2019): 17–21. http://dx.doi.org/10.21276/ajcpn.2019.7.4.4.
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Cuddihy, M. T., G. R. Locke, D. Wahner-Roedler, et al. "Dyspepsia management in primary care: a management trial." International Journal of Clinical Practice 59, no. 2 (2005): 194–201. http://dx.doi.org/10.1111/j.1742-1241.2005.00372.x.
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Nishimura, Takaaki, Shinji Konishi, Tetsuya Murakami, Hirokazu Akagi, Maeda Keita, and Shogo Suzuki. "A Trial Infrastructure Asset Management." Japanese Geotechnical Society Special Publication 1, no. 8 (2015): 5–9. http://dx.doi.org/10.3208/jgssp.jpn-02.
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Baiardi, Paola, and Veronica Santilli. "Clinical trial design and management." Pharmaceuticals, Policy and Law 12, no. 1,2 (2010): 57–62. http://dx.doi.org/10.3233/ppl-2010-0267.
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Pfeiffer, JoAnn P., and Frances J. Richmond. "Management of Clinical Trial Agreements." Therapeutic Innovation & Regulatory Science 49, no. 1 (2015): 139–45. http://dx.doi.org/10.1177/2168479014551645.
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Fazzi, F., R. Lorenzi, and G. Dondi Dall’orologio. "Efficacy of clinical trial management." Dental Materials 30 (2014): e89. http://dx.doi.org/10.1016/j.dental.2014.08.182.
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Butler, Robert N. "Clinical Trial Management of Subjects." Drug Information Journal 19, no. 4 (1985): 429–34. http://dx.doi.org/10.1177/009286158501900406.
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Rossetti, L. "Neuroprotection: A Valuable Goal in Glaucoma Management?" European Journal of Ophthalmology 17, no. 5_suppl (2007): 24–27. http://dx.doi.org/10.1177/1120672107017005s06.
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Glaucoma is characterized by an accelerated loss of retinal ganglion cells, as a result of damage to optic nerve axons. One factor involved in the disease process is elevated intraocular pressure (IOP) and this is the current focus of therapies. However, up to 45% of patients experience glaucoma progression despite good IOP control and partly as a result, the treatment principle of direct neuroprotection has been developed, which consists of treating optic nerve degeneration in glaucoma independently of IOP lowering. Animal models have shown the potential of this approach but there are limited clinical trial data. Brimonidine and memantine currently show promise, in terms of efficacy and side effects, among the compounds entering clinical trials. Brimonidine has been shown to have a neuroprotective effect independent of IOP lowering in humans with glaucoma, and data from a large clinical trial are being analyzed. Memantine has shown neuroprotective effects in animal models of glaucoma, and data from a clinical trial in humans are awaited.
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Houston, Lauren, Yasmine Probst, Ping Yu, and Allison Martin. "Exploring Data Quality Management within Clinical Trials." Applied Clinical Informatics 09, no. 01 (2018): 072–81. http://dx.doi.org/10.1055/s-0037-1621702.
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Background Clinical trials are an important research method for improving medical knowledge and patient care. Multiple international and national guidelines stipulate the need for data quality and assurance. Many strategies and interventions are developed to reduce error in trials, including standard operating procedures, personnel training, data monitoring, and design of case report forms. However, guidelines are nonspecific in the nature and extent of necessary methods. Objective This article gathers information about current data quality tools and procedures used within Australian clinical trial sites, with the aim to develop standard data quality monitoring procedures to ensure data integrity. Methods Relevant information about data quality management methods and procedures, error levels, data monitoring, staff training, and development were collected. Staff members from 142 clinical trials listed on the National Health and Medical Research Council (NHMRC) clinical trials Web site were invited to complete a short self-reported semiquantitative anonymous online survey. Results Twenty (14%) clinical trials completed the survey. Results from the survey indicate that procedures to ensure data quality varies among clinical trial sites. Centralized monitoring (65%) was the most common procedure to ensure high-quality data. Ten (50%) trials reported having a data management plan in place and two sites utilized an error acceptance level to minimize discrepancy, set at <5% and 5 to 10%, respectively. The quantity of data variables checked (10–100%), the frequency of visits (once-a-month to annually), and types of variables (100%, critical data or critical and noncritical data audits) for data monitoring varied among respondents. The average time spent on staff training per person was 11.58 hours over a 12-month period and the type of training was diverse. Conclusion Clinical trial sites are implementing ad hoc methods pragmatically to ensure data quality. Findings highlight the necessity for further research into “standard practice” focusing on developing and implementing publicly available data quality monitoring procedures.
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Bavec, F., B. Čeh Brežnik, and M. Brežnik. "Hop yield evaluation depending on experimental plot area under different nitrogen management." Plant, Soil and Environment 49, No. 4 (2011): 163–67. http://dx.doi.org/10.17221/4108-pse.
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Numerous agricultural and associated ecological effects such as mineral nitrogen fertilising influence the yield of hop (Humulus lupulus L.) cones and its quality. Using a&nbsp;wide spacing of plants (in our case 2.6 &times; 0.8 m) we want to answer a&nbsp;hypothetical question about an appropriate number of test plants per plot vs. experimental plot area. The aim of this study was to compare the effect of different rates of mineral nitrogen, fertiliser combinations and their nitrogen split application on hop yield evaluated from different plot areas (micro trial: 30 plants per plot; macro trial: 320 plants per plot). Hop yield varied significantly between treatments, plot areas, years and interactions (year &times; treatment, plot area &times; treatment) (all at P &pound; 0.01). Cone yield in a&nbsp;micro trial was higher in all treatments in comparison with yield in a&nbsp;macro trial. In spite of common intensive fertilisation the appropriate fertilising combination and mineral N rate can influence the yield. Target nitrogen rate of160 kg mineral N/ha (at the level from 40.0 to62.5 kg nitrate N/ha in soil depth to0.3 m) and cheaper combination of calcium-ammonium nitrate (50 kg N/ha) at the beginning of vegetation plus urea (110 kg N/ha) for top dressing can be recommended. On plot areas of each size and each year all treatments showed similar trends of fertilising effect on yield. In spite of higher yield in the micro trial and lower coefficient of variation in comparison with the macro trial, the results proved that a&nbsp;risk of incorrect yield analysing in macro trials is very low for field experiments.
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Prasanna Kumar C S. "An Exploratory Study on Enhancing Efficiency in Patient-Centric Clinical Trials Through Operational Management Strategies and its Impact on Research Outcome." Journal of Information Systems Engineering and Management 10, no. 31s (2025): 1032–47. https://doi.org/10.52783/jisem.v10i31s.5180.
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This exploratory study investigates the enhancement of efficiency in patient-centric clinical trials through the implementation of operational management strategies. As clinical trials increasingly prioritize patient engagement and outcomes, the need for effective operational frameworks becomes paramount. This research identifies key operational strategies, including streamlined patient recruitment processes, adaptive trial designs, and the integration of technology for real-time data collection and monitoring. By analyzing case studies and empirical data, the study evaluates the impact of these strategies on trial efficiency, patient satisfaction, and overall research outcomes. The findings suggest that a robust operational management approach not only accelerates trial timelines but also improves data quality and patient retention rates. Ultimately, this study contributes to the growing body of knowledge on optimizing clinical trial processes, emphasizing the critical role of operational management in achieving successful patient-centric research.
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Tsang, Michael, and Sanjit Jolly. "Interventional Strategies in Thrombus Management for ST Elevation Myocardial Infarction." Interventional Cardiology Review 10, no. 1 (2015): 35. http://dx.doi.org/10.15420/icr.2015.10.1.35.
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The major limitation of modern primary percutaneous coronary intervention (PPCI) is distal embolisation of thrombus and microvascular obstruction. Microvascular flow, as measured by myocardial blush grade (MPG), predicts mortality after PPCI. Despite initial enthusiasm, current evidence does not support routine use of Intracoronary over intravenous glycoprotein 2b3a inhibitors during PPCI for ST elevation myocardial infarction (STEMI) to improve clinical outcomes. Manual thrombectomy (MT) improves MPG and reduces distal embolisation in meta-analyses of small trials. A single-centre trial (N=1071), the Thrombus aspiration during percutaneous coronary intervention in acute myocardial infarction study (TAPAS) trial showed a mortality reduction, which led guidelines to recommend routine manual aspiration. However, the largest randomised trial (Thrombus aspiration in ST-elevation myocardial infarction in Scandinavia [TASTE] trial, N=7021) showed no difference in mortality and only trends towards reduction in myocardial infarction (MI) and stent thrombosis. The TASTE trial had much lower than expected mortality and so was likely underpowered for modest but important treatment effects (20–30 % RRR). The Thrombectomy with PCI versus PCI alone in patients with STEMI undergoing primary PCI (TOTAL) trial (N=10,700) will determine if MT reduces important clinical events during PPCI. Thrombus management remains an important area of research in STEMI.
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Manchikanti, Laxmaiah. "Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 2: Randomized Controlled Trials." December 2008 6;11, no. 12;6 (2008): 717–73. http://dx.doi.org/10.36076/ppj.2008/11/717.
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Evidence-based medicine (EBM) is a shift in medical paradigms and about solving clinical problems, acknowledging that intuition, unsystematic clinical experience, and pathophysiologic rationale are insufficient grounds for clinical decision-making. The importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy. Even though the concept of hierarchy of evidence is not absolute, in modern medicine, most researchers synthesizing the evidence may or may not follow the principles of EBM, which requires that a formal set of rules must complement medical training and common sense for clinicians to interpret the results of clinical research. N of 1 randomized controlled trials (RCTs) has been positioned as the top of the hierarchy followed by systematic reviews of randomized trials, single randomized trial, systematic review of observational studies, single observational study, physiologic studies, and unsystematic clinical observations. However, some have criticized that the hierarchy of evidence has done nothing more than glorify the results of imperfect experimental designs on unrepresentative populations in controlled research environments above all other sources of evidence that may be equally valid or far more applicable in given clinical circumstances. Design, implementation, and reporting of randomized trials is crucial. The biased interpretation of results from randomized trials, either in favor of or opposed to a treatment, and lack of proper understanding of randomized trials, leads to a poor appraisal of the quality. Multiple types of controlled trials include placebo-controlled and pragmatic trials. Placebo-controlled RCTs have multiple shortcomings such as cost and length, which limit the availability for studying certain outcomes, and may suffer from problems of faulty implementation or poor generalizability, despite the study design which ultimately may not be the prime consideration when weighing evidence for treatment alternatives. However, in practical clinical trials, interventions compared in the trial are clinically relevant alternatives, participants reflect the underlying affected population with the disease, participants come from a heterogeneous group of practice settings and geographic locations, and endpoints of the trial reflect a broad range of meaningful clinical outcomes. Key words: Randomized controlled trial (RCT), placebo-controlled trial, pragmatic controlled trial, randomization, allocation concealment, sample size, blinding, consolidated standards of reporting trials (CONSORT) statement, minimal clinically important change (MCIC), minimal clinical important difference (MCID)
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Viljanen-Rollinson, S. L. H., M. V. Marroni, and R. C. Butler. "Benefits from plant resistance in reducing reliance on fungicides in cereal disease management." New Zealand Plant Protection 63 (August 1, 2010): 145–50. http://dx.doi.org/10.30843/nzpp.2010.63.6556.
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Two field trials autumn and springsown with seven fungicide treatments and three wheat cultivars with different levels of resistance to Puccinia striiformis the cause of stripe rust were carried out at Lincoln during the 20092010 growing season to assess the value of utilising disease resistance within an integrated wheat disease management strategy The development of stripe rust was monitored during the season The resistant cultivar CFR02452 was free of stripe rust in all treatments including the no fungicide treatment There was more disease in the autumnsown trial than in the springsown trial The moderately resistant cultivar Torlesse had less stripe rust than the susceptible cultivar Claire in both trials and negligible disease in the springsown trial In cultivar Claire for both trials two fungicide applications that started before disease was present provided disease control that was similar to four applications but fungicide applications that commenced once the disease had established provided little control of stripe rust
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Jordanoska, Aleksandra. "Case management in complex fraud trials: actors and strategies in achieving procedural efficiency." International Journal of Law in Context 13, no. 3 (2017): 336–55. http://dx.doi.org/10.1017/s1744552316000410.
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AbstractTrials of complex fraud cases have raised numerous contentious issues in terms of procedural fairness and public resources expenditure. This paper examines the management of complex fraud trials through the lens of managerialism in the criminal justice system, analysing its effects upon procedural efficiency of the trial. The paper draws on qualitative data gathered from observations of insider-dealing trials, and interviews with prosecuting and defence lawyers and a trial judge. The findings reveal that, in practice, although dangers to procedural efficiency are constantly present throughout the trial, its successful management depends on a combination of factors vested in the actors involved and the strategies used. Whilst the increased efficiency of the trials is a reflection of managerial approaches in case management, this does not necessarily indicate a negative development in the area of the control of business misconduct, and managerialism may not be necessarily entirely undesirable in the criminal justice system.
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Steardo, Antonio. "Helicobacter pylori Therapeutics Assessment Advice on Clinical Trial Management." Pharmaceutical Methods 14, no. 1 (2023): 4. https://doi.org/10.5281/zenodo.14575892.
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The aim of this article is to assess and set all the items necessary to conduct properly a trial. Nowadays it is necessary to facilitate trial management by correct advices. The article aims to provide a guide for this. The example considers clinical trial conduction on Helicobacter pylori by its therapeutics assessment as an ease example of trial management and appropriate information to fulfil and guide any clinical trial conditions properly. Clinical trial management is the core part of the assessment on clinical trial. Advices on this seems to be meaningful to contact any clinical trial property. The article assesses property the step by step the part of a clinical trial. Helicobacter pylori is a day to day infection to fight its approach should be promptly revised.
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Marson, BA, J. Ng, Y. Myint, DJC Grindlay, and BJ Ollivere. "Management of ‘low-risk’ ankle fractures in children: a systematic review." Annals of The Royal College of Surgeons of England 101, no. 8 (2019): 539–45. http://dx.doi.org/10.1308/rcsann.2019.0027.
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Introduction This study aimed to review the literature to establish whether there is a best treatment for low-risk ankle fractures in children. Materials and methods A systematic review and meta-analysis of trials was undertaken, which compared interventions for ‘low-risk’ ankle fractures in children. A meta-analysis was performed using a random effects model. Results Four trials were identified reporting outcomes from 256 patients. All trials reported results using a device that permitted ankle motion compared with more rigid immobilisation. Overall risk of bias was low for three trials and high for one trial. Two trials assessed time to return to normal function. Patients treated in a splint or with a bandage recovering 6–7.5 days sooner than those treated with rigid immobilisation. One trial demonstrated that children returned to school sooner if treated in a bandage rather than in a cast. Two trials found a higher Activity Scale for Kids performance score at four weeks for children treated with splint compared with rigid immobilisation. There was no clear advantage to any device in patient satisfaction, quality of life or total costs. Discussion There is no clear best treatment for these injuries. Studies had significant limitations and outcomes were heterogeneous, limiting meta-analysis. Conclusion There is a need for a definitive trial to establish the best treatment for ankle fractures and a core outcome set to ensure study findings are consistent and can be analysed in future meta-analyses.
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Hirano, Tomonobu, Tomomitsu Motohashi, Kosuke Okumura, et al. "Data Validation and Verification Using Blockchain in a Clinical Trial for Breast Cancer: Regulatory Sandbox." Journal of Medical Internet Research 22, no. 6 (2020): e18938. http://dx.doi.org/10.2196/18938.
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Background The integrity of data in a clinical trial is essential, but the current data management process is too complex and highly labor-intensive. As a result, clinical trials are prone to consuming a lot of budget and time, and there is a risk for human-induced error and data falsification. Blockchain technology has the potential to address some of these challenges. Objective The aim of the study was to validate a system that enables the security of medical data in a clinical trial using blockchain technology. Methods We have developed a blockchain-based data management system for clinical trials and tested the system through a clinical trial for breast cancer. The project was conducted to demonstrate clinical data management using blockchain technology under the regulatory sandbox enabled by the Japanese Cabinet Office. Results We verified and validated the data in the clinical trial using the validation protocol and tested its resilience to data tampering. The robustness of the system was also proven by survival with zero downtime for clinical data registration during a Amazon Web Services disruption event in the Tokyo region on August 23, 2019. Conclusions We show that our system can improve clinical trial data management, enhance trust in the clinical research process, and ease regulator burden. The system will contribute to the sustainability of health care services through the optimization of cost for clinical trials.
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IGUSA, CHIZURU. "Systematization of trial management practice in St. Marianna Univ. hospital. Role of trial management room." Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics 30, no. 1 (1999): 37–38. http://dx.doi.org/10.3999/jscpt.30.37.
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Neilly, Mark D. J., Jennifer Pearson, Akari Win Thu, Carolyn MacRae, and Kevin G. Blyth. "Contemporary management of mesothelioma." Breathe 20, no. 2 (2024): 230175. http://dx.doi.org/10.1183/20734735.0175-2023.
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Pleural mesothelioma (PM) is an aggressive asbestos-associated thoracic malignancy with a median survival of 12–18 months. Due to continued asbestos use in many nations, global incidence is rising. Causes due to non-occupational, environmental exposure are also rising in many countries despite utilisation bans. For many years, platinum–pemetrexed chemotherapy was the solitary licensed therapy, but first-line combination immune checkpoint blockade has recently demonstrated improved outcomes, with both regimes tested in predominantly late-stage cohorts. In the second-line setting, single-agent nivolumab has been shown to extend survival and is now available for routine use in some regions, while second-line chemotherapy has no proven role and opportunities for clinical trials should be maximised in relapsed disease. Surgery for “technically resectable” disease has been offered for decades in many expert centres, but the recent results from the phase III MARS2 trial have challenged this approach. There remains no robustly proven standard of care for early-stage PM. The clinical trial landscape for PM is complex and increasingly diverse, making further development of specialist PM multidisciplinary teams an important priority in all countries. The observation of improving outcomes in centres that have adopted this service model emphasises the importance of high-quality diagnostics and equitable access to therapies and trials. Novel therapies targeting a range of aberrations are being evaluated; however, a better understanding of the molecular drivers and their associated vulnerabilities is required to identify and prioritise treatment targets.
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Jain, Neha M., Alison Culley, Teresa Knoop, Christine Micheel, Travis Osterman, and Mia Levy. "Conceptual Framework to Support Clinical Trial Optimization and End-to-End Enrollment Workflow." JCO Clinical Cancer Informatics, no. 3 (December 2019): 1–10. http://dx.doi.org/10.1200/cci.19.00033.
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In this work, we present a conceptual framework to support clinical trial optimization and enrollment workflows and review the current state, limitations, and future trends in this space. This framework includes knowledge representation of clinical trials, clinical trial optimization, clinical trial design, enrollment workflows for prospective clinical trial matching, waitlist management, and, finally, evaluation strategies for assessing improvement.
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Burnier, Michel. "Hypertension Management – Towards Individualisation of Therapy." European Cardiology Review 6, no. 2 (2010): 14. http://dx.doi.org/10.15420/ecr.2010.6.2.14.
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Recently, the 2007 European guidelines on hypertension management were reappraised to include the latest results of several large randomised clinical trials such as the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) and the Avoiding Cardiovascular Events in Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial. Interestingly, the new critical analysis of published clinical studies has revealed that, in some areas, current recommendations are reasonable but still poorly supported by evidence from clinical studies. Hypertension treatment strategies have also been re-considered with some interesting new conclusions. First, the concept of first-choice therapy and ranking of antihypertensive agents should probably be abandoned because it does not make much clinical sense. Second, the increasing development of combination therapies or single-pill combinations with the fascinating results obtained with the association of a blocker of the renin–angiotensin system and a calcium antagonist is being considered. Thus, since the publication of the ACCOMPLISH trial data, this type of association has become increasingly attractive. The challenge will now be to define who this drug combination will benefit and what will be the relative place of other combination therapies, such as those including a blocker of the renin–angiotensin system and a diuretic, which have been very popular so far.
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Hayoz, Stefanie, Benjamin Kasenda, Annina Lea Schenker, et al. "Completion and publication of clinical trials in a cooperative group: a cohort study of trials of the Swiss Group for Clinical Cancer Research (SAKK)." BMJ Open 13, no. 4 (2023): e068490. http://dx.doi.org/10.1136/bmjopen-2022-068490.
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BackgroundPremature trial discontinuation and non-publication of trial results are still major issues negatively affecting reliable evidence generation.ObjectivesTo investigate trial completion and publication rate of cancer trials conducted within the Swiss Group for Clinical Cancer Research (SAKK).DesignCohort study of clinical trials.SettingCohort of interventional cancer trials conducted in Switzerland with accrual closure between 1986 and 2021 identified from the SAKK trial management system.OutcomesPremature trial discontinuation and publication in peer-reviewed journal.ResultsWe included 261 trials; median number of recruited patients was 150.5 (range 1–8028). Most trials (67.0%) were randomised. Overall, 76 of 261 (29.1%) trials were prematurely closed for accrual. The three main reasons for premature closure were insufficient accrual in 28 trials, followed by stopping for futility in 17 or efficacy in 8 trials. We included 240 trials for the publication status (21 excluded, because 8 still in follow-up, for 10 the primary completion date was less than a year ago and for 3 the manuscript was submitted, but to accepted yet). 216 of 240 (90.0%) were published as a full article, 14 were published in other formats, leading to an overall publication rate of 95.8%. The rate of premature discontinuation declined over time, with 34.2%, 27.8% and 23.5% in trials activated before 2000, between 2000 and 2009, and since 2010, respectively. We observed an increasing publication rate in peer-reviewed journals over time: 79.2% (closed before 2000), 95.7% (closed between 2000 and 2009) and 93.2% (closed after 2010).ConclusionInsufficient patient recruitment is still the major reason for premature trial discontinuation. SAKK has continuously improved its quality management of trial conduct over time leading to increased successful trial completion and publication. However, there is still room for improvement to increase the number of trials reaching their target sample size.
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Macnab, Andrew J., Roy E. Gagnon, Faith A. Gagnon, Derek Blackstock, and Jacques G. LeBlanc. "Cardiac Bypass Pump Flow Management via NIRS Monitoring." Spectroscopy 17, no. 2-3 (2003): 477–82. http://dx.doi.org/10.1155/2003/693192.
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During cardiac surgery, bypass pumps rely on pressure monitors to evaluate flow. We studied whether it would be possible to optimize pump flow by monitoring changes in cerebral cytochromea,a3using NIRS to maintain cyt redox status at its pre-bypass level.Method: 18 healthy 7–45 kg swine were placed on bypass for repeated cycles of cooling and re-warming from 36 to 15 to 36°C in 3°C steps. Between each cycle, the swine's bypass pump blood flow rate was adjusted to restore cytochrome redox status to its pre-bypass value.Results: In all swine trials, the number of pump flow alterations imposed by NIRS monitoring ranged from 0 to 42, the average being 14 per trial. The best trial had 22 pump flow adjustments during which the range of cytochrome redox status change was 0.50±0.06μmol l–1. The average trial had a range of cytochrome redox status change of 1.50±0.22μmol l–1.Conclusion: NIRS-driven alterations in pump flow rate to maintain pre-bypass cytochrome redox status can be achieved successfully in the animal model.
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Anita Jumai Ehidiamen and Olajumoke Omolayo Oladapo. "The role of electronic data capture systems in clinical trials: Streamlining data integrity and improving compliance with FDA and ICH/GCP guidelines." World Journal of Biology Pharmacy and Health Sciences 20, no. 1 (2024): 321–34. http://dx.doi.org/10.30574/wjbphs.2024.20.1.0789.
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This study investigates the transformative role of Electronic Data Capture (EDC) systems in clinical trials, emphasizing their impact on data integrity, compliance with regulatory standards, and the efficiency of trial processes. The purpose of the research was to critically analyze how EDC systems align with FDA and ICH/GCP guidelines, addressing the complexities of modern clinical trials. By conducting a detailed literature review, the study explores the benefits, challenges, and technological advancements associated with EDC systems. Key findings highlight the significant advantages of EDC systems in enhancing data accuracy, real-time monitoring, and facilitating regulatory compliance through secure data management and audit trails. The study also identifies several challenges, including high implementation costs, data privacy concerns, and integration issues with other digital trial technologies. Technological advancements, such as artificial intelligence, blockchain, and decentralized trial models, are explored as promising solutions to these limitations, offering new avenues for optimizing clinical trial management. The study concludes that EDC systems have revolutionized clinical trials, streamlining data collection and analysis while ensuring compliance with stringent regulatory requirements. It recommends continued investment in EDC technologies, enhanced training for trial staff, and the integration of cutting-edge innovations to ensure future clinical trials' success.
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Kirby, K., J. Brandling, M. Robinson, S. Voss, and J. Benger. "PP27 An exploration of the experiences of paramedics taking part in a large randomised trial of airway management, and the impact on their views and practice." Emergency Medicine Journal 36, no. 10 (2019): e12.1-e12. http://dx.doi.org/10.1136/emermed-2019-999abs.27.
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BackgroundThe participation of over 1500 study paramedics in AIRWAYS-2 provides a unique opportunity for an in depth exploration of how the views and practice of study paramedics, in advanced airway management, may have developed as a result of their participation in AIRWAYS-2, and how their experiences can inform future trials in out-of-hospital cardiac arrest (OHCA). Future prehospital guidelines and practice will not only be shaped by the results of large trials such as AIRWAYS-2, but also by the views and attitudes of UK paramedics towards OHCA, airway management and research. This study allows an opportunity to add depth and understanding to the results of AIRWAYS-2.Study aimsTo explore paramedics’ experiences of participating in a large cluster randomized trial of airway management during OHCA, specifically:The challenges of enrolling patients who are critically unwell and unable to consent;Barriers and facilitators to successful research in OHCA patients;The impact on paramedics’ clinical practice and airway management during and after the trial;The role of advanced airway management during OHCA.MethodsContent analysis of an online survey of 1500 study paramedics to assess their experiences of participating in the trial and to establish any changes in their views and practice.Thematic analysis of telephone interviews with study paramedic to explore the findings of the online questionnaire. Exploring any changes in views and practice around advanced airway management as a result of participating in the trial; assessing experiences of trial training and enrolling critically unwell patients without consent, and exploring the barriers and facilitators for trial participation and the views of paramedics on the future role of advanced airway management during OHCA.Results and conclusionsThe study is in the analysis phase and is due to complete and report by the 31st January 2019.
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Yashchenko, Maria, and Svitlana Bolman. "EXPERT EVALUATION OF THE CLINICAL TRIAL MANAGEMENT MODEL WITH AN OPTIMIZED REGULATORY SYSTEM AT THE LEVEL OF A CONTRACT RESEARCH ORGANIZATION." Actual Problems of Economics 1, no. 266 (2023): 6–18. http://dx.doi.org/10.32752/1993-6788-2023-1-266-6-18.
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In this study, an expert evaluation of the clinical trial management model with an optimized regulatory system at the level of a contract research organization was conducted. The model was developed within the dissertation research regarding the impact of the regulatory system on the management of clinical trials in Ukraine. Six experts in the field of clinical trials (regulation, organization, and execution of clinical trials) were involved in the expert assessment using a semistructured interview method following the guide. The article presents the results of the expert evaluation and conclusions regarding the adaptation of clinical trial management model with an optimized regulatory system at the level of a contract research organization, considering expert opinions.
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Amallraja, Anu, Shivani Kapadia, Padmadpriya Swaminathan, Casey Williams, and Tobias Meissner. "Abstract 1899: TrialMatch: A computational resource for the management of biomarker-based clinical trials at a precision oncology center." Cancer Research 82, no. 12_Supplement (2022): 1899. http://dx.doi.org/10.1158/1538-7445.am2022-1899.
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Abstract Introduction: The adoption of routine tumor sequencing, and the incorporation of biomarker-based clinical trials in the treatment of cancer has been steadily rising over the past few years. Access and ability to participate in clinical trials is a key element in providing therapeutic options for cancer patients.At the Avera Cancer Institute, options of biomarker-based clinical trials are routinely presented to the treating clinicians at the molecular tumor board (MTB). With everincreasing numbers of trials, a systematic method for keepingtrack of available trials andevaluating patients for trial options was needed. A search for solutions led to only one open-source tool, MatchMiner, but it did not meet our needs. Methods and Results: We developed an open-source web application, TrialMatch, that has the ability to (i) add trials through a semi-automated curation interface, (ii) browse and search trials, (iii) and match patients to biomarker-based trials.TrialMatch is an R Shiny application that uses a mongo database to store the trial data. Software installation and application instantiation is managed through Docker. Curate This section has fields for a user to enter trial name and a NCT ID from clinicaltrials.gov. It then queries the clinicaltrials.gov API and fetches data about the sponsor, treatment, etc.Although disease and biomarker data are available on clinicaltrials.gov, they are not stored as discrete fields that can be queried, and hence require manual input. The user provides disease type based on the OncoTree classification, as well as biomarker information for mutations, copy numbers, fusions, TMB, MSI status, PD-L1 status, RNA expression, and disease specific markers such as ER/PR/HER2 status.All information for a particular trial is entered in a mongo database collection, with each trial stored as a document. The ability to add and edit data fields can be restricted to specific users. Browse This section allows the user to browse through all trials with key information such as NCT ID, trial name, disease, and biomarkers. Each row represents one trial and can be expanded to show more detailed information. This is useful to keep track of trials, and to quickly filter trials to a specific disease or biomarker. Match This section displays a patient-centric view of the trials that each patients’ age, sex, disease, and biomarkers have matched to. The matching can be automated for scheduled recurrentruns. At Avera, this is used during MTB to evaluate treatment options, but can also be used by clinicians to get a sense of the trials available for their patients, while awaiting formal review. Conclusion: We believe that this computational tool fulfills a crucial need in the clinical application of precision oncology, and will ultimately increase clinical trial enrollment for patients. Citation Format: Anu Amallraja, Shivani Kapadia, Padmadpriya Swaminathan, Casey Williams, Tobias Meissner. TrialMatch: A computational resource for the management of biomarker-based clinical trials at a precision oncology center [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 1899.
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S Mano, Max. "Trastuzumab emtansine: a game changer in HER2-positive early breast cancer." Future Oncology 16, no. 32 (2020): 2595–609. http://dx.doi.org/10.2217/fon-2020-0219.
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Trastuzumab emtansine (T-DM1), given postoperatively for 14 cycles to patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer (EBC) who failed to achieve a pathological complete response after standard chemotherapy and HER2 blockade, represents probably the greatest progress in the management of this aggressive form of breast cancer since the adjuvant trastuzumab pivotal trials. This article addresses the rationale behind the conception of the KATHERINE trial, T-DM1’s structure and pharmacokinetics data, clinical efficacy data of the KATHERINE trial and of other EBC trials with T-DM1, safety aspects, implications of the KATHERINE trial results to clinical practice and future perspectives in the management of HER2-positive EBC.
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De, Fina Mariarosanna, Maria Cristina Zito, Maria Diana Naturale, Stefania Esposito, and Francesco Adele Emanuela De. "Clinical Trial in Hospital Practice: Pharmacists Perspective and Risk Management Reflections." International Journal of Management Sciences and Business Research 09, no. 07 (2020): 01–08. https://doi.org/10.5281/zenodo.4966887.
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<em>In recent years the number of clinical trials has undergone a significant increase worldwide. In Europe the law n. UE 536/2014 represents an important turning point in the field of clinical trials of medicines. In an Italian national context characterized by profound revolutions and innovations, the hospital pharmacist plays an important role in the management of the protection of the human person, in terms of the rights, safety, dignity and well-being of the subjects enrolled in clinical trials.</em> <em><strong>Objects of work:</strong> Evaluate the clinical trials conducted and the complexity of management from the hospital pharmacist's perspective and analyse the complexity of the trials conducted.</em> <em>Retrospective study was carried out at Mater Domini University Hospital in Catanzaro (Italy) during 01/01/2017- 31/12/2019. The delivery to the hospital pharmacy was recorded as index data. All clinical trials started in study period were included. In order to estimate the complexity of management, a questionnaire was developed and administrated to all authors involved to clinical trial management. The questionnaires results were calculated as average scores for individual items. The scale comprises 10 close ended, pretested, highly reliable questions. The complexity score of the trial was evaluated with Cronbach’s alfa test and Pearson correlation. </em><em>In total, 94 clinical trials were started from 2017 to 2019, including 15 Therapeutic Area and 25 different Principal Investigator. In totally the Cronbach’s alfa for our complexity scale is 0.807. The Pearson correlation is particularly significant (p<0.001) for questions related to management and risk management.In conclusion, this study provided a broad representation regarding the pharmacist's perception on role on the services provided. The pharmacist involved into clinical research study is essential for mainIn recent years the number of clinical trials has undergone a significant increase worldwide. In Europe the law n. UE 536/2014 represents an important turning point in the field of clinical trials of medicines. In an Italian national context characterized by profound revolutions and innovations, the hospital pharmacist plays an important role in the management of the protection of the human person, in terms of the rights, safety, dignity and well-being of the subjects enrolled in clinical trials.</em> <em><strong>Objects of work:</strong> Evaluate the clinical trials conducted and the complexity of management from the hospital pharmacist's perspective and analyse the complexity of the trials conducted.</em> <em>Retrospective study was carried out at Mater Domini University Hospital in Catanzaro (Italy) during 01/01/2017- 31/12/2019. The delivery to the hospital pharmacy was recorded as index data. All clinical trials started in study period were included. In order to estimate the complexity of management, a questionnaire was developed and administrated to all authors involved to clinical trial management. The questionnaires results were calculated as average scores for individual items. The scale comprises 10 close ended, pretested, highly reliable questions. The complexity score of the trial was evaluated with Cronbach’s alfa test and Pearson correlation. </em><em>In total, 94 clinical trials were started from 2017 to 2019, including 15 Therapeutic Area and 25 different Principal Investigator. In totally the Cronbach’s alfa for our complexity scale is 0.807. The Pearson correlation is particularly significant (p<0.001) for questions related to management and risk management.</em><em>In conclusion, this study provided a broad representation regarding the pharmacist's perception on role on the services provided. The pharmacist involved into clinical research study is essential for maintaining the highest standards for medication safety practices and ultimately, the quality, efficacy, and safety.taining the highest standards for medication safety practices and ultimately, the quality, efficacy, and safety.</em>
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Keatinge, J. D. H., and K. Somel. "Guidelines for Improved Agronomic Management and Economic Evaluation of Crop Rotation Trials in Mediterranean Environments." Experimental Agriculture 29, no. 4 (1993): 437–47. http://dx.doi.org/10.1017/s0014479700021153.
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SummaryThis paper offers guidelines for successful crop rotation trials derived from experience at ICARDA in the period 1980–1990. Emphasis is placed on the need to determine realistically the likelihood of the long-term, successful completion of the trial and the importance of considering carefully experimental design criteria prior to trial establishment. This involves assessment of what primary and secondary information to collect for the trial, and over what duration, in order to ensure an appropriate return for the large investment generally undertaken in any crop rotation trial.Principios para ensayos con rotación de cultivos
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Singh, Gurdeep, Matthew Krauthamer, and Meghan Bjalme-Evans. "Wegovy (semaglutide): a new weight loss drug for chronic weight management." Journal of Investigative Medicine 70, no. 1 (2021): 5–13. http://dx.doi.org/10.1136/jim-2021-001952.
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Obesity is a growing epidemic within the USA. Because weight gain is associated with an increased risk of developing life-threatening comorbidities, such as hypertension or type 2 diabetes, there is great interest in developing non-invasive pharmacotherapeutics to help combat obesity. Glucagon-like peptide-1 (GLP-1) receptor agonists are a class of antidiabetic medications that have shown promise in encouraging glycemic control and promoting weight loss in patients with or without type 2 diabetes. This literature review summarizes and discusses the weight loss results from the SUSTAIN (Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes), PIONEER (Peptide Innovation for Early Diabetes Treatment), and STEP (Semaglutide Treatment Effect in People with Obesity) clinical trial programs. The SUSTAIN and PIONEER clinical trials studied the use of 1.0 mg, once-weekly, subcutaneous and oral semaglutide (a new GLP-1 homolog), respectively, on participants with type 2 diabetes. The STEP trial examined the effects of 2.4 mg, once-weekly, subcutaneous semaglutide on patients with obesity. Trial data and other pertinent articles were obtained via database search through the US National Library of Medicine Clinical Trials and the National Center for Biotechnology Information. All three clinical trials demonstrated that semaglutide (injected or oral) has superior efficacy compared with placebo and other antidiabetic medications in weight reduction, which led to Food and Drug Administration approval of Wegovy (semaglutide) for weight loss.
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Gumber, Leher, Opeyemi Agbeleye, Alex Inskip, et al. "Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions." BMJ Open 14, no. 4 (2024): e077132. http://dx.doi.org/10.1136/bmjopen-2023-077132.
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ObjectiveInternational trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. The aim of this systematic review was to identify the operational complexities of conducting international trials and identify potential solutions for overcoming them.DesignSystematic review.Data sourcesMedline, Embase and Health Management Information Consortium were searched from 2006 to 30 January 2023.Eligibility criteriaAll studies reporting operational challenges (eg, site selection, trial management, intervention management, data management) of conducting international trials were included.Data extraction and synthesisSearch results were independently screened by at least two reviewers and data were extracted into a proforma.Results38 studies (35 RCTs, 2 reports and 1 qualitative study) fulfilled the inclusion criteria. The median sample size was 1202 (IQR 332–4056) and median number of sites was 40 (IQR 13–78). 88.6% of studies had an academic sponsor and 80% were funded through government sources. Operational complexities were particularly reported during trial set-up due to lack of harmonisation in regulatory approvals and in relation to sponsorship structure, with associated budgetary impacts. Additional challenges included site selection, staff training, lengthy contract negotiations, site monitoring, communication, trial oversight, recruitment, data management, drug procurement and distribution, pharmacy involvement and biospecimen processing and transport.ConclusionsInternational collaborative trials are valuable in cases where recruitment may be difficult, diversifying participation and applicability. However, multiple operational and regulatory challenges are encountered when implementing a trial in multiple countries. Careful planning and communication between trials units and investigators, with an emphasis on establishing adequately resourced cross-border sponsorship structures and regulatory approvals, may help to overcome these barriers and realise the benefits of the approach.Open science framework registration numberosf-registrations-yvtjb-v1.
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Ishikawa, Yuka, John R. Bach, Yukitoshi Ishikawa, and Ryoji Minami. "A MANAGEMENT TRIAL FOR DUCHENNE CARDIOMYOPATHY." American Journal of Physical Medicine & Rehabilitation 74, no. 5 (1995): 345???350. http://dx.doi.org/10.1097/00002060-199509000-00005.
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Ramasamy, Arul, Joel Humphrey, and A. H. N. Robinson. "The Ankle Injury Management (AIM) trial." Bone & Joint Journal 101-B, no. 12 (2019): 1466–68. http://dx.doi.org/10.1302/0301-620x.101b12.bjj-2019-0901.
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R. Davis, Barry, M. Donald Blaufox, C. Morton Hawkins, et al. "Trial of antihypertensive interventions and management." Controlled Clinical Trials 10, no. 1 (1989): 11–30. http://dx.doi.org/10.1016/0197-2456(89)90016-0.
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Barker, Christopher, and Michael Crager. "Developing clinical trial quality management principles." Controlled Clinical Trials 13, no. 5 (1992): 395. http://dx.doi.org/10.1016/0197-2456(92)90086-f.
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