Clinical Trial Fraud: ‘Specter of Impact’ For Big Pharma Companies
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.
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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.
US is going after fraudulent clinical trial conduct, and sponsors may be faced with determining the breadth of such fraud, whether studies will be delayed and impacts on other development programs; how a sponsor handles potential fraud could define their future interactions with FDA, DoJ.
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.