Objective:

The article describes FDA–TransCelerate tabletop exercises on pragmatic clinical trials and selective safety data collection (SSDC), and discusses their implementation challenges and regulatory context in an interview with Rob DiCicco of TransCelerate.

Approach:

• Tabletop exercises: The groups used hypothetical trials reflecting real-world scenarios across four disease areas and regulatory settings, with facilitated discussion coordinated with FDA CDER’s Center for Clinical Trial Innovation (C3TI).
• Participants and topics: FDA medical reviewers, statisticians, inspection representatives, policy experts, and industry participants considered trial design, conduct, burden reduction, and targeted safety monitoring.

Key Findings:

• FDA participants offered feedback on trial design and conduct and identified areas where they believed risks remained.
• The exercises enabled experts from different FDA disciplines to discuss the same scenarios together and provided sponsors with insight into cross-functional perspectives.
• The interview describes persistent sponsor hesitation and misconceptions about regulators’ views of SSDC, alongside limited understanding of how reducing site and patient burden may expand research participation.
• Automation and direct data transfer can reduce manual data handling and may help research professionals identify potential safety signals sooner, but scaling direct data capture remains difficult.
• The interview notes that easier data collection can also encourage collection of additional measures, increasing trial complexity and burden.

Interpretation:

The interview presents the tabletop exercises as a way to explore practical trial-design questions and clarify discussions about SSDC. It states that applying these concepts in a sponsor’s own live study is ultimately important for building confidence.

Limitations:

• The scenarios were hypothetical and intentionally leaner than a typical trial proposal.
• The published summaries are not intended to serve as detailed roadmaps.
• The context provides no quantitative results or detailed outcomes for individual scenarios.
• The interview says FDA C3TI’s analysis of studies that might have used SSDC is ongoing.

Conclusion:

The exercises used hypothetical trial scenarios to discuss pragmatic trial design, burden reduction, and targeted safety monitoring. The interview also describes sponsor hesitation and practical challenges in implementing SSDC.

Sources:

• Article context: interview with Rob DiCicco, Special Advisor at TransCelerate