Aggregate Safety Assessment Planning in Clinical Trial Drug Development: Survey of Clinical Safety Professionals and Safety Data Scientists Advancing Premarket Safety Analytics at 21 Companies.

To improve the overall quality of safety reporting and to comply with requirements for aggregate IND safety reports, sponsors need to have a proactive and systematic approach for safety evaluation based on data in the aggregate.We have carried out a survey to gauge and benchmark the advancement of aggregate safety assessments in clinical trial drug development. Twenty-one companies are represented (anonymously). We summarize the results by company size (Smaller, Mid-Sized, Larger) and Overall. Since these companies and the rest of industry are in flux and there are no established standards yet, we collected information-rich free-response answers through interviews with each company.An Aggregate Safety Assessment Planning (ASAP) process empowers the multidisciplinary Safety Management Team (SMT) to plan and coordinate aggregate assessments of accumulating safety data across ongoing and completed trials throughout the product development life cycle. It strengthens cross-disciplinary communication and collaboration and facilitates a scientific evaluation of accumulating program-level safety data.Note, the ASAP process is not the only possible solution, and certainly not the final solution, to the IND Safety Reporting final rule; however, it does recognize the bigger story:• Declining value of individual expedited reports.• Increasing emphasis on aggregate causality assessments.• Emergence of multidisciplinary governance.• Documentation of sponsor reasoning.