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Oncology Clinical Trial Eligibility Expansion A Focus For US FDA; Sponsors Overcoming Initial Hesitation

 
• By Kate Rawson

US FDA plans to release a second set of guidances to industry; sponsors caution that tradeoffs need to be clear from onset.

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FDA and NCI want industry to take the plunge on clinical trail reforms. • Source: Alamy

Food & Drug Administration-led efforts to encourage oncology drug sponsors to open up pivotal trials to a broader and more diverse patient population will include the release of a second set of guidance documents outlining ways to streamline eligibility criteria, FDA Office of Oncologic Diseases Acting Deputy Director Julia Beaver said.

The US FDA hopes to build on progress from the first guidance documents finalized last year

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