Justice department has investigative tools that can uncover fraudulent activity even when a clinical site passes inspection, DoJ’s Clint Narver says; in deciding whether to self-report possible clinical trial fraud to FDA and DoJ, sponsors should consider that other companies would benefit from knowing this information about a particular site or investigator.
A “glowing” US Food and Drug Administration inspection may not protect a pharmaceutical sponsor, contract research organization or site investigator from a Department of Justice investigation into potential clinical trial fraud.
Although DoJ looks at an entity’s inspectional history, that may not tell the full story in terms of whether fraud...