Clinical Scorecard: Can Clinical Trials Collect Less Data Without Compromising Safety?

At a Glance

Key Highlights

• FDA CDER and TransCelerate used hypothetical scenarios across four disease areas and regulatory settings to discuss pragmatic trial implementation and SSDC.
• The exercises brought together FDA medical reviewers, statisticians, inspection representatives, and policy and subject-matter experts.
• Discussions addressed targeted data collection and safety monitoring for medicines with mature lifecycles and potential new or expanded indications.
• The interview describes persistent sponsor uncertainty and misconceptions about regulatory views of SSDC.
• The published exercise summaries are not detailed roadmaps but may help sponsors consider engagement with C3TI or FDA review divisions.

Guideline-Based Recommendations

Diagnosis

Management

• The interview discusses targeted data collection and safety monitoring, including SSDC, as potentially appropriate in some scenarios; it does not provide criteria for selecting data to omit.
• Published exercise summaries may help sponsors think through engagement with C3TI or FDA review divisions when facing similar scenarios.

Monitoring & Follow-up

• The interview discusses selective safety monitoring as part of SSDC but does not specify monitoring schedules or required safety measures.
• The interview states that direct data capture and transfer, when achieved, can reduce the number of people entering, querying, or modifying data and can help research professionals identify potential safety signals sooner.

Risks

• The interview says FDA provided feedback on trial design and conduct and highlighted areas where it believed risks remained.
• The source does not identify specific safety risks or establish that reducing data collection is appropriate for every trial.

Patient & Prescribing Data

No specific patient population or prescribing regimen is provided; the exercises used hypothetical trials across four disease areas and regulatory settings.

The discussion includes medicines that had matured through their lifecycles and might support new or expanded indications. No drug-specific treatment or dosing information is reported.

Clinical Best Practices

• The interview describes trial-specific discussions about whether targeted data collection and safety monitoring may be appropriate.
• The interview notes that adding questionnaires, surveys, or quality-of-life assessments can increase complexity and burden.
• The interview discusses reducing burden at site and patient levels as a potential way to expand participation in clinical research.
• The tabletop exercises involved cross-functional FDA experts and sponsor perspectives in discussions of trial design.
• The published summaries are described as not being detailed roadmaps; the interview also notes that C3TI research on SSDC is ongoing.

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