DIA 2025 Global Annual Meeting

Component Type: Session
Level: Intermediate

Planning safety reviews for a compound developed for multiple diseases is complex, requiring consistency across studies and analyses. A compound-level Data Monitoring Committee ensures unblinded safety review consistency, while an Aggregate Safety Assessment Plan (ASAP) supports post-study assessments. This presentation explores how an ASAP was implemented across a program to enable ongoing safety profile development as studies complete. It also introduces an interactive R Markdown application for real-time aggregate reviews, aligning with new draft regulatory guidance. This approach provides reviewers with access to program-level and individual study data during development, improving safety oversight. Key topics include the importance of coordination, teamwork, and standards to maintain a reliable safety database. A "year in review" will highlight lessons learned and enhancements made, concluding with an example of the application’s interactive capabilities.

Learning Objectives

Comprehend and apply the Aggregate Safety Assessment Planning (ASAP) concept to drug development and aggregate safety analysis; Implement the ASAP effectively within their organization; Identify and utilize the importance of an interactive application for performing ongoing aggregate safety reviews.

Chair

Robert (Mac) Gordon, MS