Clinical Trial Disclosure: Only ‘Tiny Fraction’ Of Thousands Of Unreported Results Cited By US FDA
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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Following request by Universities Allied for Essential Medicines, FDA creates a public dashboard of pre-notices of noncompliance on registering trials and submitting results to ClinicalTrials.gov. The agency denies request to impose civil penalties on those who fail to comply, citing its discretion.
Report by Clinical Trials Transformation Initiative identifies barriers to registration and reporting of clinical trial results to ClinicalTrials.gov and the need for centralized approach to monitor process and educate those responsible for submitting information to the site.
While small CROs have so far been the targets, former US Department of Justice official says sponsors could face enforcement action if they fail to vet them. FDA is developing policies in parallel with DOJ’s criminal initiative.