Can Clinical Trials Collect Less Data Without Compromising Safety?

Rob DiCicco discusses how FDA–industry collaboration is helping sponsors rethink safety reporting, selective safety data collection, and pragmatic clinical trial design.

By
Mouj Hijazi
October 22, 2026
8 min

The Medicine Maker

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TransCelerate and FDA CDER used hypothetical trials across four disease areas and regulatory settings to explore pragmatic trial design and selective safety data collection.
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The tabletop exercises brought together FDA medical reviewers, statisticians, inspection experts, and policy specialists to discuss trial design and implementation.
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Participants discussed targeted data collection and safety monitoring, including selective safety data collection for medicines with mature life cycles and potential new indications.
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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.
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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.

Can Clinical Trials Collect Less Data Without Compromising Safety?

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Original Source(s)

Can Clinical Trials Collect Less Data Without Compromising Safety?

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