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