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Pragmatic Oncology Trials: Survival Is Only Viable Endpoint For Now; FDA Emphasizes Streamlining

 
• By Michael McCaughan

Overall survival is the only viable endpoint for pragmatic trials in oncology, the US FDA and a panel of stakeholders agree, although other novel endpoints could be validated over time. In the meantime, FDA says, sponsors should focus on other aspects of trials that can be streamlined.

scientists gathered around desk
• Source: Shutterstock

Overall survival is the only viable endpoint for use in a fully pragmatic oncology trial design, but sponsors can work with the agency on applying pragmatic elements to other aspects of their clinical trials, a Friends of Cancer Research working group concludes.

FOCR released a white paper on incorporating pragmatic elements into oncology studies ahead of its November 14 annual meeting. The paper follows up on the FDA Oncology Center of Excellence’s “Project Pragmatica,” which was unveiled by the agency during FOCR’s 2022 annual meeting

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