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.
This article is presented for informational purposes only and is not intended to constitute legal advice.