Data and safety monitoring in NIAID clinical trials

Wednesday, October 26, 2011 — Poster Session III
10:00 a.m. – Noon	Natcher Conference Center	NIAID	RSCHSUPP-14

Authors

• S Weiss
• DO Dixon
• K Cahill
• L Fox
• J Love
• J McNamara
• L Soto-Torres

Abstract

In July 2009, the National Institute of Allergy and Infectious Diseases (NIAID) adopted a revised Policy on Data and Safety Monitoring Board (DSMB) Operations. Historically, the four divisions within NIAID (DAIDS, DAIT, DCR and DMID) operated largely independently and autonomously with respect to their approaches to data and safety monitoring. However, while some program variances may be appropriate and/or necessary, as occasions for direct collaboration have increased, NIAID has recognized the need for harmonization of policies and procedures among the divisions. From 2005 to 2009, a working group undertook a review across NIAID covering DSMB responsibilities; structure and operation; and the regulations, policies, and guidance documents governing their use. We summarize the final policy document that the working group produced; provide tabular cross-sectional overviews of how the NIAID divisions are harmonizing their DSMB operations; and highlight some recommendations for successful use of DSMBs. At NIAID, the institute-level policy document provides a collective understanding of the important contribution that DSMBs make to the responsible conduct of clinical trials. Over time, thinking will continue to evolve, leading to further policy refinements and the continued assurance of patient safety in our clinical trials.

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