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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...

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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

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Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
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UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

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What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

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