PS13: Optimizing Safety Data Practices for Clinical Trials: Insights from the C3TI SSDC Program

The CDER Center for Clinical Trial Innovation (C3TI) Demonstration Program fosters collaboration between industry and regulatory agencies to develop, implement, and evaluate innovative approaches to clinical trials. A key focus area of the program is Selective Safety Data Collection (SSDC), targeting drugs and biologics with well-characterized safety profiles. SSDC seeks to streamline data collection in late-stage pre-approval and post-approval trials by reducing unnecessary safety data, minimizing operational burdens, and enhancing the ability to address critical scientific questions about long-term efficacy and safety. The success of SSDC requires innovations in both operational practices and statistical methodologies to identify and analyze essential safety data. While safety data often receive less attention than efficacy data, the FDA has provided guidance-such as the 2012 Safety Reporting Requirements for INDs and BA/BE Studies and the 2022 E19: Selective Approach to Safety Data Collection-to outline principles and considerations for SSDC. However, these documents offer limited statistical guidance, particularly regarding causal evaluation and advanced analytical methods. This session offers a comprehensive exploration of SSDC, blending regulatory, industry, and academic perspectives to provide actionable guidance and statistical insights. Attendees will gain valuable knowledge to prepare for the C3TI SSDC program and improve safety data collection and analysis in future clinical trials.