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Data Integrity: COVID-19 Impacted Studies Pose Unique Enforcement Risks

 
• By Sue Sutter

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.

Hand turning door knob
When it comes to reporting CRO misconduct, the first pharma sponsor through the door gets more consideration from DoJ than the second. • Source: Alamy

As the US Food and Drug Administration and Department of Justice continue to make clinical trial data integrity an enforcement priority, COVID-19-impacted studies may pose unique risks in this regard.

The move toward decentralized trials spurred by the pandemic is a “very exciting development” but one that brings its own compliance and enforcement risks, Greenleaf Health Inc. principal Cynthia Schnedar...

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