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Data Integrity Fallout: Sponsors Risk Reputational Damage, Negative Impacts On Other Research

 
• By Sue Sutter

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.

Storm clouds
Findings of research misconduct can cast a 'cloud of unreliability' over all the data from a particular site or investigator. • Source: Shutterstock

Biopharma manufacturers whose clinical trials are marked by data integrity concerns must navigate a host of potentially negative consequences, including reputational damage with the US Food and Drug Administration, questions about a study’s overall veracity and viability, and the impact on other research programs.

During a panel discussion at the Food and Drug Law Institute’s recent Enforcement, Litigation and Compliance Conference, an FDA official and industry attorneys highlighted recent findings of clinical research misconduct...

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