Gene Therapy: US FDA Willing To Accept Single-Arm Trials For Approval, But Sponsors May Hesitate

 
• By Derrick Gingery

Data indicates a smaller percentage of studies intended for product registration or indication expansion are single-arm trials, compared to the proportion for all gene therapy trials.

gene therapy pills
Most registrational gene therapy clinical trials do not use single-arm designs. • Source: Shutterstock

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