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A survey of the rules for interrupting or ending subjects' participation in clinical trials for reasons of safety

Thursday, November 07, 2013 — Poster Session II

12:00 p.m. – 2:00 p.m.

FAES Academic Center (Upper-Level Terrace)




  • T.H. Mainprize
  • N.J. Aprill
  • B.A. Eagel


Well-crafted clinical protocols contain clearly written rules designed to protect research subjects in the event an experimental treatment is thought to be potentially unsafe during the conduct of the trial. These rules, commonly known as stopping rules, are safety criteria that, if met, require a decision to continue or temporarily/permanently suspend the treatment of the subjects in the trial. In recognition of the importance of these rules, all Regulatory Compliance and Human Subjects Protection Branch/Program (RCHSPB/P) sponsored IND protocols, by policy, require stopping rules. The RCHSPB Clinical Safety Office (CSO), as part of an ongoing review of safety language in clinical protocols, conducted an internal survey of the stopping rules in current protocols. The survey sample consisted of 146 protocols that were ongoing from 2003 to 2010. The results of this survey indicated that between protocols there was a broad range in the number and severity of safety events that required stoppage. Inconsistencies were observed in the terms, procedures, and reporting responsibilities that define how trials should be stopped/resumed or ended. These findings support the rationale for the development and inclusion of clearly stated stopping rules in the safety template language, first introduced by the CSO in August 2011.

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