Results 211 to 220 of about 41,384 (251)

Data-monitoring committees in clinical trials

The Lancet, 1993
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Data Monitoring Committees in adaptive clinical trials

Clinical Investigation, 2013
Data 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, 1993
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 ...
S, Green, J, Crowley
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On the Independence of Data Monitoring Committee in Adaptive Design Clinical Trials

Journal of Biopharmaceutical Statistics, 2012
In 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, Ralph, Corey, Min, Lin   +2 more
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Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees

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, Ralph S, Freedman, Jay, Herson, Michael, Hughes, KyungMann, Kim, Michael H, Silverman, Catherine M, Tangen   +6 more
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Data Monitoring Committees in Clinical Trials

2002
Data monitoring committees in clinical trials , Data monitoring committees in clinical trials , کتابخانه دیجیتال جندی شاپور ...
Susan S Ellenberg, Thomas R Fleming, David L DeMets   +2 more
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Data and Safety Monitoring Committees in Clinical Trials

Journal of Biopharmaceutical Statistics, 2018
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...
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Decision Analysis for a Data Monitoring Committee of a Clinical Trial

1998
A data monitoring committee holds a position of great trust within the structure of a US clinical trial, as it alone receives the accumulating data and decides whether to continue the trial. The committee generally meets at regularly scheduled intervals, e.g. six months.
Joseph B. Kadane, Pantelis Vlachos, Samuel Wieand   +2 more
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Coordinating Data Monitoring Committees and Adaptive Clinical Trial Designs

Drug Information Journal, 2008
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.
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Data monitoring committees and randomized clinical trials

Kidney International, 2019
Howard, Trachtman, Arthur L, Caplan
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