Clinical Trial Endpoints May Not Fit Real-World Studies
Symptom control, overall survival and time to treatment failure may be more useful measures in a real-world setting than progression-free survival, FDA oncology director Pazdur says.
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Abernethy comes to FDA from Flatiron Health, which develops oncology-specific electronic health record software and real-world evidence for cancer research. She succeeds FDA veteran Rachel Sherman, who will retire from the agency in January.
Under the Information Exchange and Data Transformation initiative, existing clinical trial datasets will be standardized and integrated with real-world sources in a new data environment.
Agency would consider a site-agnostic indication for tumors with high mutation burden if results from the proposed pragmatic clinical practice study were positive.