1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

More from R&D

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.