Enhancing the Scientific Integrity and Safety of Clinical Trials: Recommendations for Data Monitoring Committees

Lewis et al talk about the risks of participating in a clinical trial which cannot be predicted with certainty at the time of trial design, especially when evaluating novel therapies. Accordingly, once the trial is initiated, periodic and ongoing review of accumulating study data is necessary to ens...

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Veröffentlicht in:JAMA : the journal of the American Medical Association 2016-12, Vol.316 (22), p.2359-2360
Hauptverfasser: Lewis, Roger J, Calis, Karim A, DeMets, David L
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creator Lewis, Roger J
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description Lewis et al talk about the risks of participating in a clinical trial which cannot be predicted with certainty at the time of trial design, especially when evaluating novel therapies. Accordingly, once the trial is initiated, periodic and ongoing review of accumulating study data is necessary to ensure the continued appropriateness of enrolling and treating patients in the trial.
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source MEDLINE; American Medical Association Journals
subjects Clinical trials
Clinical Trials as Topic - ethics
Clinical Trials as Topic - standards
Clinical Trials Data Monitoring Committees
Patient Safety
Risk
Therapy
Treatment Outcome
title Enhancing the Scientific Integrity and Safety of Clinical Trials: Recommendations for Data Monitoring Committees
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