Moving the Needle on Clinical Trial Diversity and Navigating New FDA Requirements for Diversity Action Plans
Kellie Combs
Partner
Ropes & Gray LLP
Ronni Fuchs
Partner
Troutman Pepper Hamilton Sanders LLP
Jennifer Jones-McMeans, PhD
Divisional Vice President, Global Clinical Affairs
Abbott
Katrina Long
Senior Director, Assistant General Counsel
Regeneron Pharmaceuticals, Inc.
- Devising a clinicical trial diversity action plan: what can industry do in practice to improve diversity in clinical trials and overcome operational challenges and obstacles in this endeavor
- Understanding the different roles of sponsors, patients, and investigators in conducting more equitable clinical trials
- Examining the new FDA clinical trial diversity requirements set forth by the Food & Drug Omnibus Reform Act of 2022
- Understanding what will be required in the development of Diversity Action Plans to improve the enrollment of racial and ethnic populations in clinical trials
- Exploring FDA’s toolkit for encouraging study sponsors to meet diversity goals
- Taking a look at specific strides life sciences companies are making to increase clinical trial diversity – what is working and what is not?