5 Key Takeaways

• 1

  TransCelerate and FDA CDER used hypothetical trials across four disease areas and regulatory settings to explore pragmatic trial design and selective safety data collection.

• 2

  The tabletop exercises brought together FDA medical reviewers, statisticians, inspection experts, and policy specialists to discuss trial design and implementation.

• 3

  Participants discussed targeted data collection and safety monitoring, including selective safety data collection for medicines with mature life cycles and potential new indications.

• 4

  DiCicco said automation can reduce manual data handling and help research professionals identify potential safety signals sooner, but easier collection can also increase data burden.

• 5

  Sponsors face myths and uncertainty about regulators’ views of selective safety data collection, while FDA C3TI research has examined whether its use could have affected study findings.