Clinical Trial Disclosure: Only ‘Tiny Fraction’ Of Thousands Of Unreported Results Cited By US FDA

 
• By Brenda Sandburg

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.

Clinical trial
JAMA piece encourages US FDA to do more to ensure sponsors report results of clinical trials to ClinicalTrials.gov • Source: Alamy

More from Clinical Trials

More from R&D