Online Program

Return to main conference page
Tuesday, September 24
Tue, Sep 24, 4:15 PM - 5:30 PM
Thurgood Marshall South
Challenges in Safety Monitoring for Basket Design Trials

Challenges in Safety Monitoring for a Master Protocol Trial Mimicking Real-World Setting (300958)

*Sue-Jane Wang, FDA/CDER 

Keywords: Master Protocol, Monitor, Safety, Real-World Setting

We consider a master protocol design in a post-marketing requirement setting. As the aim is to further investigate potential safety induced consequences of post-approved medical imaging drugs, relevant clinical practices in real-world setting, e.g., of a medical imaging drug class, are key considerations for design feasibility. Under this framework, we articulate study rationales, give study objectives and study endpoints in a few scenarios. We will also lay out challenges including trial logistics, safety monitoring and trial implementation in use of master protocol design in the post-approval setting. Should traditional safety monitoring approaches be applied or alternative safety monitoring strategies be considered in such a setting ? Perspectives on some approaches to potentially mitigate challenges in safety monitoring of a safety trial while maintaining the study goals on trial flexibility and trial feasibility will be given.