Philadelphia, PA -- Martin Mendoza, Director of Extramural Research, Office of Minority Health at the FDA, shared a perspective on inclusion and diversity in clinical trials.


The problem is easily demonstrated by the numbers. In the U.S., African Americans represent 12% of the population but only 5% of the clinical trial population. Hispanics are 17% of the U.S. population but only 3% of the clinical trial population. Those numbers get a little better when we look at NIH trials (10% of all trials).


The problem is exacerbated as trials become more global and are increasingly held in countries that are not as diverse.


Representation is critical because minorities may respond differently to medical products. There are well known cases in cancer and heart failure in which medicines show very different responses or side effects in minority subgroups vs. full trial populations. It’s critical that we have that data to best support and educate patients.


The reasons why subpopulations don’t participate are familiar:

  • Historical mistrust
  • Inadequate recruitment and retention
  • Misunderstanding of minorities beliefs and values
  • Misperceptions that minorities are ineligible or don’t want to participate
  • Lack of awareness on the patient’s part


But research shows, monitories will participate if asked. Mendoza said:


  • 91% of African American surveyed would consider participating in a clinical trial
  • 71% of Hispanics surveyed both knew what a clinical trial was would consider participating


The Office of Minority Health is charged with addressing some of those disparities. Their vision is to create a world where health equity is a reality for all.


Their work is fueled largely by the FDA Safety and Innovation Act (2012). That law was fueled by a group of advocacy organizations that lobbied Congress for legislation to require reporting of inclusion data on women and minorities in clinical trials. Section 907 of the Act requires development of inclusion data from medical treatment applications and action plans to address inequities.


The guidance the FDA has developed since starts with clinically relevant enrollment. Sponsors should enroll participants that reflect disease prevalence and the patients that will ultimately use them. A plan for inclusion should be submitted to the agency no later than the phase 2 meeting.


The FDA is not expecting change from pharma alone. They’re investing their own resources in change as well. Last year they launched a campaign focused on clinical diversity to focus on the importance of minority participation in clinical trials. The PSAs, social media and print materials included both scientists and patients, and were targeted at potential trial participants and their doctors and influencers. New programs will be launched soon to empower and educate potential Hispanic participants and give doctors specific tools and approaches to talk with patients about trials. 


*Disclaimer: Mentions contained in these posts do not indicate any association between the products and companies and INC Research/inVentiv Health. All details, statistics and figures are taken from the noted presentation.

About the Author:

As Managing Director of Innovation for Syneos Health Communications, Leigh is responsible for shaping the company’s perspective on the next era of healthcare marketing. Through thought leadership, strategic innovation workshops and new products and capabilities, Leigh focuses on identifying marketing approaches that will fuel that new era and generate significant growth for clients. Leigh has worked with Fortune 1000 companies to craft their digital, mobile, social and CRM strategies for over 17 years. She’s worked for category-leading agencies in retail, public affairs, B2B technology, and higher education. Prior to moving to Syneos Health Communications, she had several leadership roles at one of our agencies, GSW. There, she founded an innovation practice fueled by the zeitgeist and spearheaded digital and innovation thinking across the business. Leigh has taken a special interest in complex healthcare products that can change lives in meaningful ways. She was recently a strategic lead on the 3rd largest launch in pharmaceutical history: Tecfidera. Before that she had keys roles with Eli Lilly Oncology, Abbott Nutrition, Amgen Cardiovascular, and Eli Lilly Diabetes. A critical part of Leigh’s work is trends and new ideas. Every year, she convenes a group of trend watchers from across our global network to identify the shifts most critical to healthcare marketers. Leigh is a sought-after writer and speaker. Recognized as one of the most inspiring people in the pharmaceutical industry by PharmaVoice, Leigh also was recognized as a Rising Star by the Healthcare Businesswomen's Association (HBA) for her overt passion, industry thought leadership and significant contributions in new business, strategy and mentoring.