What To Watch As EU Clinical Trial Compliance Changes

By Sonia Nath, Elisabethann Wright and Natasha Leskovsek (July 13, 2021, 6:47 PM EDT) -- Earlier this year, industry became more intimately familiar with the clinical trials reporting requirements in the U.S. when, on April 27, the U.S. Food and Drug Administration sent a notice of noncompliance to Acceleron Pharma Inc. identifying the company's failure to submit study results from a November 2017 trial that tested the efficacy of dalantercept and axitinib, proposed treatments for renal cell carcinoma.

As sponsors and principal investigators seek to learn from the Acceleron example, it is important for industry to consider reporting requirements not just in the U.S., but also for the European Union given the Clinical Trials Regulation, which,...

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