FDA Wants Sponsors to Submit Diversity Recruitment Plans in INDs and IDEs
(Thursday, April 14, 2022)
Despite more than 10 years of prodding the industry, most products approved by FDA are still based on clinical trials conducted mostly on Caucasian volunteers. In future, FDA will require that sponsors present a formal written plan to recruit underrepresented racial and ethnic populations in the US for pivotal trials with drugs, biologics, and medical devices. But does this help or create more paper with limited desirable impact? Almost all pivotal clinical trials allow recruitment of diverse patient populations, and no sponsor would deliberately exclude ethnic minorities in their trials. However, despite almost 40 years of increased regulations to protect the rights and welfare of all clinical trial participants, the underrepresented racial and ethnic populations (U-REPs) in the US are suspicious of clinical trials and do not volunteer to the same extent as Caucasians. Clinical trials recruit much fewer black or African Americans, Hispanic/Latino, indigenous and native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of color in the US. Most diversity of clinical trial participants is contributed by non-US sites since most pivotal trials are conducted in multi-national settings. FDA and DHHS has launched numerous programs to educate these populations in the US about the benefits of participating in clinical trials with limited success. Now the FDA would like to pass on some of the responsibility to recruit subjects from these populations in the US to the sponsors of clinical trials. Sponsors of clinical trials will be “asked” to submit “Racial and Ethnic Diversity Plan” as soon as possible in the clinical development plan but no later that the End-of-Phase 2 meeting or submission of the IDE application for devices. Any meetings with FDA at those stages will be expected to include this Plan. In this Plan, sponsors will be required to define enrollment goals based on PK, PD and pharmacogenomic data from the diverse population. The Plan must include measures to collect data from diverse population and planned statistical analysis of the impact of ethnic factors on the safety and effectiveness of the investigational product. Although the Guidance Document contains disclaimers that these suggestions are voluntary for sponsors, the tone of the Guidance document presents this as a required exercise for a favorable FDA review. While having the right intent and a plan to implement recruitment from diverse populations is certainly beneficial, the problem of mistrust in the U-REPs towards clinical trials remains the biggest hurdle to recruit these populations, and no amount of forcing the sponsors would help with the goal. The most practical way to collect data from diverse populations has been by including non-US sites in the pivotal trials, as suggested by previous FDA Guidance Documents. Combining that with the Racial and Ethnic Diversity Plan for US patients will probably be the most plausible way to get the needed data, going forward, without excessively delaying patient access to new drugs.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC