The OIG has issued a report entitled “Data and Safety Monitoring Boards in NIH Clinical Trials: Meeting Guidance, But Facing Some Issues.” The report examines the effectiveness of data and safety monitoring boards (DSMB) – or committees of experts that provide ongoing reviews of clinical trial data to ensure the safety of study subjects and validity and integrity of data. Based on a review of 44 National Institutes of Health (NIH) funded Phase III multi-site clinical trials that were completed in 2009 and 2010 that entailed potential risk, the OIG concluded that DSMBs met general NIH guidance in this area, including with regard to the experience of DSMB members. The OIG identified several potential issues, however, including that NIH participation in closed DSMB meetings diminishes the appearance of independence and not all NIH Institutes and Centers (IC) policies reference DSMB access to unmasked data. Based on these findings, the OIG recommends that NIH: direct ICs to delineate the circumstances in which IC staff should participate in DSMB meetings; direct IC DSMB policies to explicitly reference DSMB access to unmasked data, and identify ways to recruit and train new DSMB members. NIH concurred with the recommendations.
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OIG examines clinical trial data and safety monitoring boards
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