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

Gaps Found In Most Pharma Trial Diversity Policies

 
• By Sarah Karlin-Smith

A study suggests industry groups like PhRMA could use more of their influence to hold members accountable on trial diversity policies.

white piece of paper with hole ripped in center revealing yellow background.
Drug companies need to plug holes in their clinical trial diversity plans, a study found. • Source: Shutterstock

The average pharma company clinical trial diversity policy contains less than half of the commitments recommended by the US Food and Drug Administration, other regulators, and industry trade groups to improve the composition of their studies, a new BMJ study found.

Key Takeaways

  • While most large pharma companies have a publicly available policy on clinical trial diversity, only one-fifth of non-large companies had one.

  • Many large company plans had gaps in key focus areas for the FDA, such as patient-focused drug development and broad inclusion criteria

The findings suggest the need for more comprehensive policies as the FDA is set to require diversity action plans for pivotal trials in an attempt to ensure trial enrollment more closely reflects the population of patients who will use medicines. (Also see "Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says" - Pink Sheet, 26 June, 2024

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

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.