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  1. Data and Safety Monitoring Boards: Some Enduring Questions.Charles J. Kowalski & Jan L. Hewett - 2009 - Journal of Law, Medicine and Ethics 37 (3):496-506.
    Data Safety and Monitoring Boards have been referred to as a “growth industry,” and this trend continues to be fueled by recent FDA guidance and the NIH's requirement that DSMBs be employed in virtually all phase III clinical trials. The widening role of DSMBs has been sporadically questioned on ethical grounds, but growth has continued, despite the fact that many of the questions endure, unanswered, save for repeated references to safeguarding the scientific integrity of trials. This may be about to (...)
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  • Data and Safety Monitoring Boards: Some Enduring Questions.Charles J. Kowalski & Jan L. Hewett - 2009 - Journal of Law, Medicine and Ethics 37 (3):496-506.
    Data Safety and Monitoring Boards were introduced in the 1960s to monitor data in clinical trials to ensure subject safety. It was thought important that DSMB members be experts in the field of interest, but not otherwise involved in the study in order to maximize objectivity. Since then, the use of DSMBs has increased dramatically, and their scope has expanded to include scientific issues — in particular, to avoid bias that can result when trials are stopped early because of evidence (...)
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