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A proposed charter for clinical trial data monitoring committees: helping them to do their job well
Lancet, The, 2005 Formal monitoring of data from randomised controlled trials (RCTs) is becoming more common. Wide variation exists in the structure and organisation of data monitoring committees (DMCs), with little guidance on how they should operate.
DAMOCLES Study Group, NHS Health Technology Assessment Programme
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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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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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Decision Analysis for a Data Monitoring Committee of a Clinical Trial
1998A 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 +2 more
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Coordinating Data Monitoring Committees and Adaptive Clinical Trial Designs
Drug Information Journal, 2008There 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, 2019Howard, Trachtman, Arthur L, Caplan
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Data monitoring committees in clinical trials: best practice, complexities and considerations
Clinical Investigation, 2015What 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 ‘
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Data Monitoring Committees in Clinical Trials: A Practical Perspective
The American Statistician, 2022openaire +1 more source
Clinical Trials of Herpes Simplex Encephalitis: The Role of the Data Monitoring Committee
2006Herpes simplex encephalitis (HSE) is the most frequent cause of focal necrotizing encephalitis, accounting for approximately 2,500 cases annually in the United States. Studies initiated in the early 1970s have continuously evaluated promising antiviral drugs for the treatment of this disease, utilizing randomized, blinded, controlled clinical trial ...
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