Developing training for Data Safety Monitoring Board (DSMB) members: A National Institute of Allergy and Infectious Diseases (NIAID) case study

Thursday, October 11, 2012 — Poster Session IV
2:00 p.m. – 4:00 p.m.	Natcher Conference Center, Building 45	NIAID	RSCHSUPP-25

Authors

• JA Zuckerman
• KJ Cahill
• BC van der Schalie
• LA McNay

Abstract

Background: Despite the substantial responsibilities DSMB members assume, there is limited information in the literature about the unique set of knowledge DSMB members must possess, and consequently, the training that they require in order for them to fulfill their obligations. Methods: The NIAID conducted a comprehensive literature search and interviewed DSMB subject matter experts from academic institutions, pharmaceutical companies and the National Institutes of Health to: 1) assess if DSMB training is an identified need, 2) evaluate whether DSMB training has been developed and 3) to formulate suitable learning objectives. DSMB training modules were developed based on the identified learning objectives identified from the interviews. Conclusions: The NIAID identified that DSMB training is not widely available for DSMB members to build the unique knowledge and skills necessary to serve on DSMBs. Consequently, NIAID developed publically available web-based DSMB training modules for new or inexperienced DSMB members. The training is comprised of 3 modules; an introduction to the objectives and purpose of DSMBs, the organization and responsibilities of DSMBs and statistical topics.

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