Keywords: Inter-Disciplinary, Aggregate Assessment, IND Safety Reporting
This session will be tied to the 2015 FDA draft (or final, if available) guidance on interdisciplinary aggregate assessments for IND safety reporting and will serve as a forum to discuss key topics in the guidance. Many companies have been trying to establish internal processes and teams to implement this guidance. Practical challenges and concerns have arisen during implementation. For example, should the unblinded aggregated SAE analysis, involving ongoing pivotal studies, be performed internally or through an external group? What is an appropriate threshold to trigger a Safety Assessment Committee to further investigate the causal association of an SAE with the investigational drug? How do we determine anticipated SAE rates, especially for studies without a control arm? In addition, controversy over the merits of blinded vs unblinded monitoring still exists. In this session, experience and thoughts on handling these practical issues will be shared and discussed. Dr Ball from the DIA-ASA Interdisciplinary Safety Evaluation scientific working group will provide a summary of guidance and industry experience. The majority of time will be devoted to a panel discussion of experts from academia, industry, and regulatory authorities.
Speaker: Greg Ball (Merck); Panelists: Jacqueline Corrigan-Curay (FDA), Estelle Russek-Cohen (FDA); Jay Herson (Johns Hopkins), Frank Rockhold (Duke), Susan Duke (FDA), Amit Bhattacharyya (ACI Clinical)