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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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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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Data Monitoring Committees in Clinical Trials: A Practical Perspective
The American Statistician, 2022openaire +1 more source
Data Monitoring Committees in Clinical Trials
Journal of the Royal Statistical Society: Series D (The Statistician), 2003openaire +1 more source
Data Monitoring Committees in Clinical Trials
2019Susan S. Ellenberg +2 more
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Data and Safety Monitoring Committees in Clinical Trials
2009Jay Herson, Jay Herson
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FDA and Clinical Trial Data Monitoring Committees
2006Susan S. Ellenberg, Jay P. Siegel
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[Data monitoring committees. Third pillar in the methodical conduct of clinical trials].
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 2008Data Monitoring Committees (DMC) are increasingly becoming integrated into the methodical procedure of clinical trials, in order to support sponsors in their central role. Whereas monitors and auditors, respectively, give quality assuring recommendations in compliance with GCP, an implemented DMC is able to give sponsors far-reaching recommendations ...
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