Results 211 to 220 of about 41,480 (249)
Who's minding the data? Data Monitoring Committees in clinical cancer trials [PDF]
Sociology of Health and Illness, 2009 AbstractModern biomedicine is based on a number of novel institutions and practices that, in order to function, require some degree of formal and informal regulation. This paper contributes to the ongoing investigation of these processes, and the forms of objectivity they generate, by examining the emergence, development and deployment of Data ...
Alberto Cambrosio, Peter Keating
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The Use of Data Monitoring Committees in Clinical Trials
Drug Information Journal, 1996This paper provides an overview of the role of data monitoring committees in ensuring patient safety and validity and scientific merit of the trial. This more formalized data monitoring approach tends to be used only in trials where there is a lot at stake. Use of data monitoring committees at the National Institutes of Health and results of a workshop
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Independent Academic Data Monitoring Committees for Clinical Trials in Cardiovascular and Cardiometabolic Diseases [PDF]
European Journal of Heart Failure, 2017 Abstract Data Monitoring Committees (DMCs) play a crucial role in the conducting of clinical trials to ensure the safety of study participants and to maintain a trial's scientific integrity. Generally accepted standards exist for DMC composition and operational conduct.
Tim Friede +2 more
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Data Monitoring Committees in adaptive clinical trials
Clinical Investigation, 2013Data Monitoring Committees (DMCs) have been widely utilized in clinical trials for study monitoring. The DMC, independent of any activities related to clinical operation of the study, is a group of individuals with pertinent expertise who review on a regular basis accumulating data from one or more ongoing clinical trials [1].
Min Lin, Shein-Chung Chow
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Data monitoring committees for southwest oncology group clinical trials
Statistics in Medicine, 1993AbstractA monitoring committee policy was established by the Southwest Oncology Group in 1985 to address documented problems in study conduct. Committees consisting of the study co‐ordinators, disease committee chair, study statistician, Group chair, Group statistician, an uninvolved Southwest Oncology Group clinician, an NCI representative, and a ...
S, Green, J, Crowley
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On the Independence of Data Monitoring Committee in Adaptive Design Clinical Trials
Journal of Biopharmaceutical Statistics, 2012In clinical trials, an independent data monitoring committee (DMC) is often established to perform both ongoing safety data monitoring and interim efficacy analysis. These evaluations are performed in a blinded fashion in order to avoid possible operational biases that may be introduced to the trial after the review of the data.
Shein-Chung, Chow +2 more
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Clinical Trials, 2006
This is a commissioned report by a writing committee formed by the Society for Clinical Trials. The committee was formed with the objectives of 1) reviewing data monitoring guidelines for confirmatory (phase III) trials published by the National Institutes of Health, US Food and Drug Administration, Veterans Administration, and the International ...
Dennis O, Dixon +6 more
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This is a commissioned report by a writing committee formed by the Society for Clinical Trials. The committee was formed with the objectives of 1) reviewing data monitoring guidelines for confirmatory (phase III) trials published by the National Institutes of Health, US Food and Drug Administration, Veterans Administration, and the International ...
Dennis O, Dixon +6 more
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Data Monitoring Committees in Clinical Trials
2002Data monitoring committees in clinical trials , Data monitoring committees in clinical trials , کتابخانه دیجیتال جندی شاپور ...
Susan S Ellenberg +2 more
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Data and Safety Monitoring Committees in Clinical Trials
Journal of Biopharmaceutical Statistics, 2018The book by Dr. Herson is written amazingly well. The book concentrates on pharmaceutical industry-sponsored confirmatory clinical trials and can serve as excellent sources of knowledge for all the...
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