The Changing Standards for FDA Oncology Approvals: Talal Hilal, MD

The FDA approval process is in place to ensure that drugs are safe and effective before they are made available to the public. But do the clinical trials that lead to approval truly ascertain whether a drug is efficacious? Fully two-thirds of anticancer drug clinical trials leading to FDA approvals between 2014 and 2019 had at least one important limitation in trial design: lack of randomization, lack of significant overall survival advantage, inappropriate use of crossover, and/or use of a...
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FDA Oncology Approvals: Limitations In Clinical Trial Design

Fully two-thirds of anticancer drug clinical trials leading to FDA approvals over the course of a five-year period from 2014 to 2019 had at least one important limitation that could potentially impact the utility of the results, report the authors of an observational study published today in JAMA Internal Medicine. "Clinical trials leading to marketing authorization of anticancer drugs by the US Food and Drug Administration (FDA) are heterogeneous, with varying strengths and weaknesses," write t...
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