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 |
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creator | Lewis, Roger J Calis, Karim A DeMets, David L |
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. |
doi_str_mv | 10.1001/jama.2016.16070 |
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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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