Stopping NIAID clinical trials for safety

Monday, September 22, 2014 — Poster Session I
12:00 p.m. – 2:00 p.m.	FAES Academic Center	NIAID	RSCHSUPP-17

* FARE Award Winner

Authors

• T Mainprize
• B Eagel

Abstract

Clinical research protocols should contain detailed rules for interrupting a study for safety to protect subjects from treatments that cause unacceptable harm during the conduct of a clinical trial. Results of a survey of 146 NIAID clinical protocols, ongoing between 2003 and 2010, showed wide variation in how unsafe treatments should be stopped. To ensure that future protocols contained well-crafted rules, the Clinical Safety Office (CSO) introduced template safety language, in August 2011. The template language used well-defined terms, clear decision making and reporting responsibilities, and specified predetermined safety criteria for each protocol. The terms “pausing” and “halting” were introduced to specify rules for interrupting the treatment of individuals and all subjects on the trial, respectively. With the introduction of the template, the CSO has conducted an evaluation of the use and feedback of this template. An overview of Institutional Review Board (IRB) stipulations, including a pre- and post-template comparison is a useful tool in the annual review of this language.

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