CTTI’s Executive Committee recently approved the IND Safety Advancement Project. This project is a follow-up to CTTI’s IND Safety Project, which issued recommendations in late 2013. These recommendations are intended to improve clinical trials by helping sponsors to ensure recognition of important safety issues for study drugs and biologics as early as possible during development.

Both of these projects were initiated in response to the FDA’s final rule published on September 29, 2010. This rule established new reporting requirements for serious and unexpected adverse reactions occurring in clinical trials conducted under an investigational new drug application (IND) (CFR 21.312). Although this rule, which was intended to improve the overall quality of safety, was published nearly four years ago, anecdotal reports indicate that implementation problems remain, particularly in oncology clinical trials.

While the original IND Safety Project sought to better understand current practices among sponsors for assessing and communicating the safety of an IND, the advancement project focuses on clarifying motivations and challenges to full implementation of the IND safety reporting rule. The anticipated impact of this new project is an increase in compliance with respect to assessment, communication, review, and management of serious adverse events and serious unexpected safety adverse reports.

Please visit the CTTI website for regular project updates.