CTTI has published its findings on remaining barriers and potential solutions to full implementation of the FDA final rule on IND safety reporting by investigators, clinical research staff, and sponsors.
In 2010, the FDA final rule established new reporting requirements for serious and unexpected suspected adverse events occurring in clinical trials conducted under an IND. Follow-up FDA guidance clarified sponsors’ role and that they should not submit expedited safety reports for individual cases of serious adverse events for which it does not appear the drug caused the event. It was anticipated that these changes could increase the interpretability of safety reports while decreasing the volume and burden of reporting.
Through a series of surveys and interviews, the results of which were published in the journal Clinical Trials, CTTI discovered that while all groups agreed on the intention of the final rule in increasing early communication of safety signals, they also indicated that the rule was not being strictly implemented. Interviewees reported that the major challenges included lack of global harmonization in reporting rules, difficulties determining causality, and fear of regulatory repercussions, some of which could be improved with increased interaction with the FDA itself.
These findings, which resulted from CTTI’s IND Safety Reporting Project, support recommendations developed by CTTI and underpin educational materials created for sponsors to increase compliance with the final rule, and to facilitate discussion between sponsors, investigators, and FDA representatives. CTTI gathered input on these findings and their impact in a multi-stakeholder expert meeting (a meeting summary is available for additional context) and hosted a webinar to provide guidance on handling a variety of safety reporting situations.
CTTI would like to thank the interview participants and project team members who contributed to this work.