The FDA's Center for Clinical Trial Innovation has published a white paper outlining its regulatory framework for selective safety data collection (SSDC) in late-stage clinical trials for drugs with well-characterized safety profiles.
The SSDC approach allows for planned reduction in collecting certain safety data types, including common non-serious adverse events and routine laboratory assessments, when such data is unlikely to provide additional clinically important knowledge.
Real-world examples demonstrate successful implementation across therapeutic areas, including the Pragmatica-Lung Study which limited safety collection to grade 3+ adverse events and the VICTORION-2-PREVENT study which reduced visit frequency from monthly to every 6 months.
The framework promises to reduce participant burden, lower study costs, and accelerate drug development while maintaining patient safety standards, though adoption remains limited despite international regulatory harmonization.
