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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
semanticscholar   +3 more sources

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
semanticscholar   +4 more sources

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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...
X. Jia
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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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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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Data monitoring committees in clinical trials: best practice, complexities and considerations

Clinical Investigation, 2015
What is the problem all about? Clinical trials are sometimes described as being rather ‘blunt’ instruments, and that often may be true: we use them to find answers to very broad questions such as ‘does this drug work better than a control drug?’ But they are also very important and delicate instruments: we use them to find answers to questions such as ‘
S. Day
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Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute.

Journal of Clinical Oncology, 1997
PURPOSE To describe the rationale for independent data monitoring committees (DMCs) for National Cancer Institute (NCI)-sponsored phase III cooperative group clinical trials.
Malcolm A. Smith, R. Ungerleider, E. Korn, Lawrence Rubinstein, Richard Simon   +4 more
semanticscholar   +2 more sources

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.
J. Herson
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Data Monitoring Committees in Clinical Trials

Journal of the Royal Statistical Society: Series D (The Statistician), 2003
M. A. Best
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Data Monitoring Committees in Clinical Trials: A Practical Perspective.

Controlled Clinical Trials, 2003
P. Grambsch
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