Clinical Data Integrity: Clean US FDA Inspection No Guarantee That DoJ Won’t Investigate
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.
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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.
Move toward decentralized trials means sponsors may be working with naïve clinical investigators who lack experience, Greenleaf’s Cynthia Schnedar says; DoJ’s Gustav Eyler urges drug sponsors to look for oddities in clinical trial data and to voluntarily report potential misconduct.
Sponsors must decide whether to repeat bioequivalence and other studies after two CROs were found to have potentially falsified data, causing the US FDA to reject all data produced by the firms.