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Relevant bibliographies by topics / Clinical trials data

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Academic literature on the topic 'Clinical trials data'

Author: Grafiati

Published: 4 June 2021

Last updated: 1 February 2022

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Journal articles on the topic "Clinical trials data"

1

Catanzaro, Linda M., and Gene D. Morse. "Data from Clinical Trials." JAIDS Journal of Acquired Immune Deficiency Syndromes 38, Supplement 1 (2005): S26—S29. http://dx.doi.org/10.1097/01.qai.0000167036.48772.c8.

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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

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Burgess, David C., Val J. Gebski, and Anthony C. Keech. "Baseline data in clinical trials." Medical Journal of Australia 179, no. 2 (2003): 105–7. http://dx.doi.org/10.5694/j.1326-5377.2003.tb05447.x.

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George, Stephen L., and Marc Buyse. "Data fraud in clinical trials." Clinical Investigation 5, no. 2 (2015): 161–73. http://dx.doi.org/10.4155/cli.14.116.

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Wilcox, Allen, and Sholom Wacholder. "Observational Data and Clinical Trials." Epidemiology 19, no. 6 (2008): 765. http://dx.doi.org/10.1097/ede.0b013e318188e872.

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Albrich, J. Michael. "Data Bases of Clinical Trials." New England Journal of Medicine 340, no. 1 (1999): 65–66. http://dx.doi.org/10.1056/nejm199901073400119.

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Song, Juwon. "Clinical trials with missing data." Biometrics 71, no. 2 (2015): 558–59. http://dx.doi.org/10.1111/biom.12319.

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RESNIK, DAVID. "Data Falsification in Clinical Trials." Science Communication 18, no. 1 (1996): 49–58. http://dx.doi.org/10.1177/1075547096018001003.

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Wilson, J. R. "Data audit for clinical trials." JAMA: The Journal of the American Medical Association 270, no. 22 (1993): 2685b—2685. http://dx.doi.org/10.1001/jama.270.22.2685b.

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Wilson, John R. "Data Audit for Clinical Trials." JAMA: The Journal of the American Medical Association 270, no. 22 (1993): 2685. http://dx.doi.org/10.1001/jama.1993.03510220041025.

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Dissertations / Theses on the topic "Clinical trials data"

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Bari, Wasimul. "Analyzing binary longitudinal data in adaptive clinical trials /." Internet access available to MUN users only, 2003. http://collections.mun.ca/u?/theses,167453.

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Zhang, Paul. "Multiple imputation of missing data in clinical trials." Thesis, National Library of Canada = Bibliothèque nationale du Canada, 2001. http://www.collectionscanada.ca/obj/s4/f2/dsk3/ftp05/NQ63596.pdf.

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Penny, Kay Isabella. "Multivariate outlier detection in laboratory safety data." Thesis, University of Aberdeen, 1995. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.282687.

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Clinical laboratory safety data consist of a wide range of biochemical and haematological variables which are collected to monitor the safety of a new treatment during a clinical trial. Although the data are multivariate, testing for abnormal measurements is usually done for only one variable at a time. A Monte Carlo simulation study is described, which compares 16 methods, some of which are new, for detecting multivariate outliers with a view to finding patients with an unusual set of laboratory measurements at a follow-up assessment. Multivariate normal and bootstrap simulations are used to

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Kilgore, Meredith L. "Effects of trial design on participation and costs in clinical trials : with an examination of cost analysis methods and data sources /." Santa Monica, Calif. : Pardee RAND Graduate School, 2004. http://www.rand.org/publications/RGSD/RGSD179.

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Rehal, Sunita. "Implications of missing data in tuberculosis non-inferiority clinical trials." Thesis, University College London (University of London), 2018. http://discovery.ucl.ac.uk/10059380/.

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Non-inferiority designs have been increasingly used in randomised clinical trials in recent years. However, there remain several key issues with this design that can have important implications for the primary analysis and its interpretation. Specifically, choosing the population for inclusion in the primary analysis and how to deal with missing values, remains unclear. This thesis tackles three related methodological issues in tuberculosis (TB) clinical trials: (i) a lack of clear guidance on design and reporting; (ii) the need for a valid approach to missing data and (iii) how to perform sen

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Cro, S. "Relevant accessible sensitivity analysis for clinical trials with missing data." Thesis, London School of Hygiene and Tropical Medicine (University of London), 2017. http://researchonline.lshtm.ac.uk/3817571/.

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The statistical analysis of longitudinal randomised controlled trials is frequently complicated by the occurrence of protocol deviations which result in incomplete datasets for analysis. However analysis is approached, an unverifiable assumption about the distribution of the unobserved post-deviation data must be made. In such circumstances it is consequently important to assess the robustness of the primary analysis of the trial to different credible assumptions about the distribution of the missing data. Reference based multiple imputation procedures have been proposed for contextually relev

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Blatchford, Patrick Judson. "Monitoring bivariate endpoints in group sequential clinical trials /." Connect to full text via ProQuest. Limited to UCD Anschutz Medical Campus, 2007.

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Thesis (Ph.D. in Biostatistics) -- University of Colorado Denver, 2007.<br>Typescript. Includes bibliographical references (leaves 104-106). Free to UCD affiliates. Online version available via ProQuest Digital Dissertations;

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McHugh, Gillian Stephanie. "Efficient analysis of ordinal data from clinical trials in head injury." Thesis, University of Edinburgh, 2012. http://hdl.handle.net/1842/6479.

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Many promising Phase II trials have been carried out in head injury however to date there has been no successful translation of the positive results from these explanatory trials into improved patient outcomes in Phase III trials. Many reasons have been hypothesised for this failure. Outcomes in head injury trials are usually measured using the five point Glasgow Outcome Scale. Traditionally the ordinality of this scale is disregarded and it is dichotomised into two groups, favourable and unfavourable outcome. This thesis explores whether suboptimal statistical analysis techniques, including t

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Mason, Tracey. "Application of survival methods for the analysis of adverse event data." Thesis, Keele University, 1999. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.267646.

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The concept of collecting Adverse Events (AEs) arose with the advent of the Thalidomide incident. Prior to this the development and marketing of drugs was not regulated in any way. It was the teterogenic effects which raised people's awareness of the damage prescription drugs could cause. This thesis will begin by describing the background to the foundation of the Committee for the Safety of Medicines (CSM) and how AEs are collected today. This thesis will investigate survival analysis, discriminant analysis and logistic regression to identify prognostic indicators. These indicators will be de

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Iqbal, Gulnaz. "Improving ethnicity data collection and ethnic minority participation in randomised clinical trials." Thesis, University of Warwick, 2013. http://wrap.warwick.ac.uk/59153/.

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UK ethnic minority patients are reported to be under-represented in clinical trials. Under-representation of any patient group within an Randomised Clinical Trial can bias trial results and subsequent extrapolation into the general population. However, the true extent of ethnic minority representation in RCTs is masked by the poor quality of ethnicity data. This thesis investigates ethnicity data collection in healthcare and the representation of ethnic minority patients in RCTs in the UK. A systematic literature review of ethnicity data collection identified a paucity of published evidence. S

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Books on the topic "Clinical trials data"

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DeMets, David L., Curt D. Furberg, and Lawrence M. Friedman, eds. Data Monitoring in Clinical Trials. Springer US, 2006. http://dx.doi.org/10.1007/0-387-30107-0.

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Spilker, Bert. Data collection forms in clinical trials. Raven Press, 1991.

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Management of data in clinical trials. Wiley, 1998.

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McFadden, Eleanor. Management of data in clinical trials. 2nd ed. Wiley-Interscience, 2008.

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Ellenberg, Susan S., Thomas R. Fleming, and David L. DeMets. Data Monitoring Committees in Clinical Trials. John Wiley & Sons, Ltd, 2019. http://dx.doi.org/10.1002/9781119512684.

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Management of data in clinical trials. 2nd ed. J. Wiley, 2008.

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Rüdiger, Müller. Clinical trials in rheumatology. Springer, 2013.

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Jacqueline, Benedetti, and Crowley John 1946-, eds. Clinical trials in oncology. 2nd ed. Chapman & Hall, 2003.

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Herson, Jay. Data and safety monitoring committees in clinical trials. Chapman & Hall/CRC/Taylor & Francis, 2009.

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von, Kempis Johannes, and SpringerLink (Online service), eds. Clinical Trials in Rheumatology. Springer-Verlag London Limited, 2011.

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Book chapters on the topic "Clinical trials data"

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Pocock, Stuart J. "Forms and Data Management." In Clinical Trials. John Wiley & Sons Ltd,., 2013. http://dx.doi.org/10.1002/9781118793916.ch11.

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Callcut, Rachael A. "Data Safety Monitoring Boards." In Clinical Trials. Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-35488-6_11.

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Pocock, Stuart J. "Further Aspects of Data Analysis." In Clinical Trials. John Wiley & Sons Ltd,., 2013. http://dx.doi.org/10.1002/9781118793916.ch14.

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Swords, Douglas S., and Benjamin S. Brooke. "Clinical Trials: Handling the Data." In Clinical Trials. Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-35488-6_10.

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Poulose, Benjamin K. "Planning for Data Monitoring and Audits." In Clinical Trials. Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-35488-6_12.

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Iber, Frank L., W. Anthony Riley, and Patricia J. Murray. "Principles of Data Management." In Conducting Clinical Trials. Springer US, 1987. http://dx.doi.org/10.1007/978-1-4613-1919-1_16.

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Iber, Frank L., W. Anthony Riley, and Patricia J. Murray. "Computer Technology in Data Management." In Conducting Clinical Trials. Springer US, 1987. http://dx.doi.org/10.1007/978-1-4613-1919-1_24.

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Cleophas, Ton J., and Aeilko H. Zwinderman. "Randomized Clinical Trials, History, Designs." In Understanding Clinical Data Analysis. Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-39586-9_3.

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Friedman, Lawrence M., Curt D. Furberg, and David L. DeMets. "Issues in Data Analysis." In Fundamentals of Clinical Trials. Springer New York, 2010. http://dx.doi.org/10.1007/978-1-4419-1586-3_17.

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Friedman, Lawrence M., Curt D. Furberg, David L. DeMets, David M. Reboussin, and Christopher B. Granger. "Issues in Data Analysis." In Fundamentals of Clinical Trials. Springer International Publishing, 2015. http://dx.doi.org/10.1007/978-3-319-18539-2_18.

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Conference papers on the topic "Clinical trials data"

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Cameron, Fraser, Nihat Baysal, and B. Wayne Bequette. "A differential simulator using past clinical trial data to run simulated clinical trials." In 2015 American Control Conference (ACC). IEEE, 2015. http://dx.doi.org/10.1109/acc.2015.7172135.

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Bhati, D. K. "Informatics in clinical trials: Evidences from Clinical Data Management." In 2013 Indian Conference on Medical Informatics and Telemedicine (ICMIT). IEEE, 2013. http://dx.doi.org/10.1109/indiancmit.2013.6529402.

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Djumanov, Dilshat, and Peter Dabnichki. "DinamapBP-automatic data acquisition system for clinical trials." In 2008 Second International Conference on Pervasive Computing Technologies for Healthcare (PervasiveHealth). IEEE, 2008. http://dx.doi.org/10.1109/pcthealth.2008.4571095.

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Zhou, Zheng, Sander S. Chao, Jasper Lee, Brent Liu, Jorge Documet, and H. K. Huang. "A data grid for imaging-based clinical trials." In Medical Imaging, edited by Steven C. Horii and Katherine P. Andriole. SPIE, 2007. http://dx.doi.org/10.1117/12.710636.

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Djumanov, Dr Dilshat, and Dr Peter Dabnichki. "DinamapBP-Automatic Data Acquisition System for Clinical Trials." In 2nd International ICST Conference on Pervasive Computing Technologies for Healthcare. ICST, 2008. http://dx.doi.org/10.4108/icst.pervasivehealth2008.2494.

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Norris, Brook, Lauren Neighbors, and Lucas Wale. "Abstract 06: Streamlining data management for clinical trials." In Abstracts: AACR Special Conference on Advancing Precision Medicine Drug Development: Incorporation of Real-World Data and Other Novel Strategies; January 9-12, 2020; San Diego, CA. American Association for Cancer Research, 2020. http://dx.doi.org/10.1158/1557-3265.advprecmed20-06.

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Smith, Stephen, and Samuel Sambasivam. "Web Based Data Capture for Clinical Research." In InSITE 2008: Informing Science + IT Education Conference. Informing Science Institute, 2008. http://dx.doi.org/10.28945/3201.

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Electronic Data Capture (EDC) is increasingly being used in the pharmaceutical, biotech and medical device industries to gather research data worldwide from doctors, hospitals and universities participating in clinical trials. In this highly regulated environment, all systems and software must be thoroughly tested and validated, a task that is burdensome in terms of time and cost. Starting with database structures that are designed to be copied easily, this paper proposes a simple framework that allows for rapid development and minimal testing. The framework includes tools for building modules

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SUBBAIAH, PERLA, AVISHEK MALLICK, and TUSAR K. DESAI. "META ANALYSIS OF BINARY OUTCOMES DATA IN CLINICAL TRIALS." In Proceedings of Statistics 2011 Canada/IMST 2011-FIM XX. WORLD SCIENTIFIC, 2013. http://dx.doi.org/10.1142/9789814417983_0017.

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Haak, Daniel, Charles-E. Page, and Thomas M. Deserno. "Electronic data capture and DICOM data management in multi-center clinical trials." In SPIE Medical Imaging, edited by Jianguo Zhang and Tessa S. Cook. SPIE, 2016. http://dx.doi.org/10.1117/12.2218257.

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Hadad, Ben, and Boaz Lerner. "Domain adaptation from clinical trials data to the tertiary care clinic – Application to ALS." In 2020 19th IEEE International Conference on Machine Learning and Applications (ICMLA). IEEE, 2020. http://dx.doi.org/10.1109/icmla51294.2020.00090.

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Reports on the topic "Clinical trials data"

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Scharfstein, Daniel, Aidan McDermott, Elizabeth Stuart, Tianjing Li, and Chenguang Wang. New Methods and Software to Determine the Impact of Missing Data in Clinical Trials. Patient-Centered Outcomes Research Institute® (PCORI), 2019. http://dx.doi.org/10.25302/11.2019.me.13036016.

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DiBenedetti, Dana B., T. Michelle Brown, Carla Romano, Claire Ervin, Sandy Lewis, and Sheri Fehnel. Conducting Patient Interviews Within a Clinical Trial Setting. RTI Press, 2018. http://dx.doi.org/10.3768/rtipress.2018.op.0054.1808.

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Qualitative data centered on patients’ experiences and perspectives typically go uncollected in clinical trial settings. Yet patients’ treatment experiences offer complementary insights and context on topics such as disease management, treatment gaps, and previous treatments outside of those gathered in traditional patient-reported outcome questionnaires. Qualitative interviews can capture patients’ perceptions of treatment needs, more fully explore meaningful changes experienced as a result of treatment, and reveal outcomes that are most important to patients. Asking patients detailed questio

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Treadwell, Jonathan R., James T. Reston, Benjamin Rouse, Joann Fontanarosa, Neha Patel, and Nikhil K. Mull. Automated-Entry Patient-Generated Health Data for Chronic Conditions: The Evidence on Health Outcomes. Agency for Healthcare Research and Quality (AHRQ), 2021. http://dx.doi.org/10.23970/ahrqepctb38.

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Background. Automated-entry consumer devices that collect and transmit patient-generated health data (PGHD) are being evaluated as potential tools to aid in the management of chronic diseases. The need exists to evaluate the evidence regarding consumer PGHD technologies, particularly for devices that have not gone through Food and Drug Administration evaluation. Purpose. To summarize the research related to automated-entry consumer health technologies that provide PGHD for the prevention or management of 11 chronic diseases. Methods. The project scope was determined through discussions with Ke

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Lumpkin, Shamsie, Isaac Parrish, Austin Terrell, and Dwayne Accardo. Pain Control: Opioid vs. Nonopioid Analgesia During the Immediate Postoperative Period. University of Tennessee Health Science Center, 2021. http://dx.doi.org/10.21007/con.dnp.2021.0008.

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Background Opioid analgesia has become the mainstay for acute pain management in the postoperative setting. However, the use of opioid medications comes with significant risks and side effects. Due to increasing numbers of prescriptions to those with chronic pain, opioid medications have become more expensive while becoming less effective due to the buildup of patient tolerance. The idea of opioid-free analgesic techniques has rarely been breached in many hospitals. Emerging research has shown that opioid-sparing approaches have resulted in lower reported pain scores across the board, as well

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Carney, Nancy, Tamara Cheney, Annette M. Totten, et al. Prehospital Airway Management: A Systematic Review. Agency for Healthcare Research and Quality (AHRQ), 2021. http://dx.doi.org/10.23970/ahrqepccer243.

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Objective. To assess the comparative benefits and harms across three airway management approaches (bag valve mask [BVM], supraglottic airway [SGA], and endotracheal intubation [ETI]) by emergency medical services in the prehospital setting, and how the benefits and harms differ based on patient characteristics, techniques, and devices. Data sources. We searched electronic citation databases (Ovid® MEDLINE®, CINAHL®, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and Scopus®) from 1990 to September 2020 and reference lists, and posted a Federal

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Johnson, Corey, Colton James, Sarah Traughber, and Charles Walker. Postoperative Nausea and Vomiting Implications in Neostigmine versus Sugammadex. University of Tennessee Health Science Center, 2021. http://dx.doi.org/10.21007/con.dnp.2021.0005.

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Purpose/Background: Postoperative nausea and vomiting (PONV) is a frequent complaint in the postoperative period, which can delay discharge, result in readmission, and increase cost for patients and facilities. Inducing paralysis is common in anesthesia, as is utilizing the drugs neostigmine and sugammadex as reversal agents for non-depolarizing neuromuscular blockers. Many studies are available that compare these two drugs to determine if neostigmine increases the risk of PONV over sugammadex. Sugammadex has a more favorable pharmacologic profile and may improve patient outcomes by reducing P

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Xing, Lei, Hongmin Guo, and Zhiqian Wang. Efficacy and safety of Suzi Jiangqi Decoction in patients with acute exacerbation of chronic obstructive pulmonary disease A protocol for systematic review and meta analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, 2021. http://dx.doi.org/10.37766/inplasy2021.8.0035.

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Background: Chronic obstructive pulmonary disease (COPD) is characterized by chronic respiratory symptoms. The respiratory symptoms of patients with acute exacerbation of COPD (AECOPD) worsen rapidly. At present, traditional western medicine treatment can not effectively alleviate the symptoms and attack frequency of patients. Suzi Jiangqi decoction(SZJQ) has a good clinical effect in the treatment of AECOPD. Due to the lack of evidence-based medicine, it can not provide an effective systematic evaluation for the treatment of AECOPD with Suzi Jiangqi decoction. Therefore, it is necessary to pr

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Harris, Gregory, Brooke Hatchell, Davelin Woodard, and Dwayne Accardo. Intraoperative Dexmedetomidine for Reduction of Postoperative Delirium in the Elderly: A Scoping Review. University of Tennessee Health Science Center, 2021. http://dx.doi.org/10.21007/con.dnp.2021.0010.

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Background/Purpose: Post-operative delirium leads to significant morbidity in elderly patients, yet there is no regimen to prevent POD. Opioid use in the elderly surgical population is of the most significant risk factors for developing POD. The purpose of this scoping review is to recognize that Dexmedetomidine mitigates cognitive dysfunction secondary to acute pain and the use of narcotic analgesia by decreasing the amount of norepinephrine (an excitatory neurotransmitter) released during times of stress. This mechanism of action also provides analgesia through decreased perception and modul

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Dy, Sydney M., Julie M. Waldfogel, Danetta H. Sloan, et al. Integrating Palliative Care in Ambulatory Care of Noncancer Serious Chronic Illness: A Systematic Review. Agency for Healthcare Research and Quality (AHRQ), 2020. http://dx.doi.org/10.23970/ahrqepccer237.

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Objectives. To evaluate availability, effectiveness, and implementation of interventions for integrating palliative care into ambulatory care for U.S.-based adults with serious life-threatening chronic illness or conditions other than cancer and their caregivers We evaluated interventions addressing identification of patients, patient and caregiver education, shared decision-making tools, clinician education, and models of care. Data sources. We searched key U.S. national websites (March 2020) and PubMed®, CINAHL®, and the Cochrane Central Register of Controlled Trials (through May 2020). We a

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Saldanha, Ian J., Wangnan Cao, Justin M. Broyles, et al. Breast Reconstruction After Mastectomy: A Systematic Review and Meta-Analysis. Agency for Healthcare Research and Quality (AHRQ), 2021. http://dx.doi.org/10.23970/ahrqepccer245.

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Objectives. This systematic review evaluates breast reconstruction options for women after mastectomy for breast cancer (or breast cancer prophylaxis). We addressed six Key Questions (KQs): (1) implant-based reconstruction (IBR) versus autologous reconstruction (AR), (2) timing of IBR and AR in relation to chemotherapy and radiation therapy, (3) comparisons of implant materials, (4) comparisons of anatomic planes for IBR, (5) use versus nonuse of human acellular dermal matrices (ADMs) during IBR, and (6) comparisons of AR flap types. Data sources and review methods. We searched Medline®, Embas

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