Clinical Trial Disclosure: Only ‘Tiny Fraction’ Of Thousands Of Unreported Results Cited By US FDA
Executive Summary
Yale researchers call on FDA to send more pre-notices of noncompliance to those who have not reported trial results. Of 58 pre-notices in last eight years, 56% went to pharma industry and none went to federal agencies. Commissioner-in-waiting Califf is expected to focus on trial reporting.
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