The FDA issued a draft guidance in December 2015 on Safety Assessment for IND Safety Reporting. This guidance was developed as a follow-on to the 2010 guidance for Safety Reporting Requirements for INDs and BA/BE Studies and provides recommendations to help sponsors meet their obligations under 21 CFR 312.32. The FDA provides recommendations on the composition and role of a safety assessment committee, aggregate analyses for comparison of adverse event rates across treatment groups, planned unblinding of safety data, reporting thresholds for IND safety reporting, and development of a safety surveillance plan.

Page 4 of the guidance references CTTI work conducted by the IND Safety Project Team. (Recommendations developed during this project are available here.) The FDA addressed an observation that emerged during the IND Safety Project’s analysis of the evidence from surveys and multi-stakeholder expert meetings: sponsors have concerns about protecting trial integrity when reviewing serious adverse data from ongoing trials. To maintain trial integrity while assessing safety signals, the FDA recommends that sponsors use a safety assessment committee and develop a safety surveillance plan.

Comments on this draft guidance will be accepted until February 16, 2016.

CTTI continues to work in this area: the IND Safety Advancement Project is a follow-on to the IND Safety Project. This follow-on project seeks to promote full implementation of the FDA’s final rule by addressing particular challenges in oncology trials and generalizing solutions to other therapeutic areas.