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

Califf: Sponsors Should Go Beyond Letter Of Law With Trial Diversity Plans

 
• By Sarah Karlin-Smith

The FDA Commissioner wants sponsors to incorporate diversity into their development programs prior to Phase III.

diverse group of people with hands in the middle
FDA Commissioner Robert Califf said trial diversity will improve through analysis of trial diversity plans. (Shutterstock)
Key Takeaways
  • FDA Commissioner Robert Califf wants sponsors to exceed legal requirements and incorporate diversity into their entire development programs.
  • Califf is hopeful industry and the FDA will learn how to improve trial diversity by analyzing the required diversity action plans.
  • He acknowledged that postmarket work likely will be necessary to address diversity questions in small studies.

FDA Commissioner Robert Califf wants industry to exceed legal requirements and incorporate diversity efforts into earlier phase trials, not just pivotal studies.

The diversity actions plans (DAPs) required in the 2022 Food and Drug Omnibus Reform Act, apply to Phase III or other pivotal clinical trials where enrollment begins 180...

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 Diversity & Inclusion

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Makary Signals Some Interest In US FDA Staff Cuts, Fighting Patent Thickets

 
• By Sarah Karlin-Smith

The FDA Commissioner nominee also commented on trial diversity, the role of public comment and expedited biosimilar reviews during his Senate confirmation hearing.

US FDA Says Restored Webpages Do Not Reflect ‘Biological Reality’

 
• By Sue Sutter

Clinical trial draft guidance webpages are back online following a court order, but with new language disclaiming any information promoting gender ideology as "extremely inaccurate."

More from R&D

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.