Real-World Evidence Could Help Relax Clinical Trial Enrollment Criteria
FOCR study suggests overall survival for PD-1s seen in real-world datasets is similar to results from clinical trials.
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AstraZeneca Tagrisso, Pfizer Xalkori Stand Out Among US FDA’s Single-Arm Oncology Approvals, JAMA Suggests
Only two US approvals based on single-arm trials met the European Society for Medical Oncology’s threshold for substantial clinical benefit, according to an analysis of cancer drugs approved over a decade.
Death typically is not included in electronic health records, and sources are disparate; Difficulties with endpoint expose potential limitation to real-world evidence use.
CDER Director Woodcock says for regulatory purposes, using real-world data likely will remain a case-by-case decision.