When Can You Trust Real-World Evidence? Experts Point Out Pitfalls
Speedy publication and data validation methods were red flags in studies retracted by Lancet and NEJM, IQIVA’s Nancy Dreyer says. Duke-Margolis and Sanofi researchers note growth in use of real-world evidence in drug applications at DIA’s annual meeting.
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Retraction of Lancet, NEJM studies does not signal doubts about the utility of RWE for evaluating drug efficacy and safety; instead, it highlights importance of transparency, validation and audit trails for real-world datasets, and lack of familiarity with RWE methods among medical journal peer reviewers, experts say.
Director of the US FDA’s Office of New Drugs says there will be a greater focus on identifying the optimal dose before a drug candidate advances into Phase III trials, but the problem is not limited to oncology, the target of Project Optimus.
Peter Stein says FDA will set criteria for holding a virtual meeting and will be seeking stakeholder feedback.