Results 261 to 270 of about 100,822 (314)
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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
Susan Ellenberg
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Data monitoring committees for southwest oncology group clinical trials
AbstractA 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 ...
Stephanie Green, John Crowley
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Data Monitoring Committees in Clinical Trials
Data 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
The 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...
Xiaohu Jia
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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 ...
SCT Working Group on Data Monitoring +7 more
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Coordinating Data Monitoring Committees and Adaptive Clinical Trial Designs
There is a growing interest in employing adaptive clinical trial designs in drug development. Adaptation is usually based on accumulative efficacy data alone. This article examines issues that can arise when an independent data monitoring committee must interface their safety concerns when adaptive changes based on efficacy are taking place.
Jay Herson
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Data monitoring committees and randomized clinical trials
Howard Trachtman, Arthur L. Caplan
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FDA and Clinical Trial Data Monitoring Committees
Susan S. Ellenberg, Jay P. Siegel
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Data Monitoring Committees in Clinical Trials: A Practical Perspective.
Patricia M. Grambsch
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