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US FDA Solicits Comments On Barriers To Innovative Trial Design Implementation

 
• By Derrick Gingery

In admitting problems, the FDA creates a docket for comments and will convene a public workshop in the spring on why the clinical trial innovation is not more widespread.

breaking barriers
The docket on barriers to implementing clinical trial innovations is expected to open later this month. • Source: Shutterstock

Sponsors soon have a chance to advise the US Food and Drug Administration on the barriers and facilitators to implementing innovative clinical trial designs.

The agency has more than a dozen programs aimed at fostering various ideas that could improve the clinical trial system, and by extension, speed drug development

How FDA Will Get Feedback

To improve adoption of innovative clinical trials, CDER is “conducting internal workshops and listening sessions and is working in partnership with Duke Margolis Center for Health Policy to host a public workshop” on March 19 and 20, 2024.

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