Long-Term Postmarket Studies For Gene Therapies May Need To Be Combined, Standardized

 
• By Derrick Gingery

Running multiple product-specific postmarket trials for 15 years or longer would not be cost-effective and one industry stakeholder suggests workstreams eventually could merge.

postmarket research
With multiple regulators expected to mandate postmarketing studies, standard requirements would be beneficial, Tito Roccia said. • Source: Shutterstock

Standardization of methods and trials may be necessary for long-term post-approval data collection on cell and gene therapies to be feasible.

US Food and Drug Administration officials want 15 years or more of postmarketing follow-up for new cell and gene therapies,...

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