The FDA Diversity Plans to Improve Enrollment of Underrepresented Racial and Ethnic Populations in Clinical Trials: Why We Must Do More

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In April 2022, The FDA released its Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trial Guidance for Industry. The 12-page guidance document offers information that represent the FDA’s suggestions and recommendations for sponsors currently developing medical products on an approach for developing their own Race and Ethnicity Diversity Plan. The stated goal with these plans is to enroll proper representative numbers from underrepresented racial and ethnic groups in the US in clinical trials.

Tigerlily Foundation has served as a 16 years as a national breast cancer foundation, with a grassroots and patient-driven base, to improve the landscape of medical care for marginalized groups. Through programs such as our ANGEL Advocacy Program, our HEAL Policy Center of Excellence and #InclusionPledge, along with our other initiatives, we work to amplify the voices of and work to increase representation of Black women – a population that experiences egregious inequities as it pertains to clinical trials.?We know the facts:

????????Metastatic Breast Cancer disproportionately affects the Black community and younger women

????????Black women and white women get breast cancer at about the same rate, but Black women are 40% more likely to die from breast cancer than white women.

????????Black women are more likely than white women to get triple-negative breast cancer, a kind of breast cancer that is often aggressive and recurs after treatment.

????????Due to a legacy of exploitation of people of color in the clinical trial/scientific/research settings, Black women have a mistrust of the scientific, healthcare system and providers.

????????African American women have significantly lower enrollment in clinical trials, which makes it more difficult to design treatments for this population, which may contribute to lower mortality rates.

????????There is evidence that Black women’s breast cancers have different physiological characteristics than other populations.

????????21% of Black Women with breast cancer do not survive 5 years past their diagnosis, versus 8% of White Women.

????????The clinical trial participation of Black women is less than 5%.

While industry, community organizers, sponsors, healthcare providers and others stakeholders are working towards changing these statistics, things are not moving fast enough for many who are dying at disproportionate rates, while we continue to see more articles, landscape assessments, surveys and hosting of panel discussions on the topic and problems than actual implementation of specific, measurable, timebound tactics and policies that have proven to ensure diversity in clinical trials.?The FDA’s recommendations provide a much need action plan to jumpstart the changes that need to be made to ensure inclusive care; yet these recommended guidelines only scratch the surface of ideal action in clinical trials.

And while it is a big step forward for the FDA to issue these diversity guidelines to sponsors, optimal recommendations should include more actionable items that result in accountability of these programs to follow through with their promises to patients. ?

Tigerlily responded with our feedback for consideration that the “Diversity Plan” elements should include greater specificity and clarity on certain topics. The below are highlights into several of those recommendations:

1. A Community Engagement Plan: If a community advisory board is created, it must include patients or patients at risk of the disease under study and reflect Black, Indigenous, and people of color (BIPOC) patient representation at different disease stages, ages, sexual orientations, and gender, and with representation from patient advocacy organizations. We also recommend specific community engagement plans that focus on education about clinical trials and listening to the community, versus a seagull approach where we swoop in to "fix the problem" or to take, versus working beside the community - with the community members leading the way.

2. Eligibility Criteria: A Diversity Plan should provide justification and community insights to ensure that the eligibility criteria do not work against the inclusion of underrepresented populations in the catchment area for lead sites.?In addition, BIPOC people and patients should being a part of the development and approval of eligibility criteria.

3. Provide Resources for Patients to Address/Overcome Barriers to Trial Adherence: The Diversity plan should include how the sponsor provides appropriate provision and programs for study participants to address and overcome barriers, especially socio-economic barriers that disproportionately affect BIPOC and marginalized communities, based on feedback from the community advisory board and other stakeholders.

4.?Site Selection: Sites are more often located in U.S. locations that have the supportive resources to run a trial. ?Sponsors should demonstrate how the site catchment areas for their study reflects a diverse population for the disease being studied.?In addition, sponsors must demonstrate a sustainable commitment to support the clinical trial infrastructure for underserved communities, to include developing a diverse site workforce and training. It is important that sponsors stand up new sites that are viable for future research to ensure access to representative populations.? In addition, it is important that the diversity plan demonstrates a commitment to ongoing site utilization for add on studies (of different types) or analyses. Sites should also be stood up in medically underserved communities in a way that eliminates barriers to clinical trials and ensures access for the population being recruited for the trial.

5. Diversity Plan Adherence:?While this guidance is recommended, it is not enforceable, but enforcement and accountability are key tenets that will show success.?Unless it is enforceable, these recommendations are just that – recommendations - some sponsors will meet the goals and some will just try.?However, for populations that continue to have the highest disease burden, recommendations unfortunately don’t equate to timely, lifesaving treatments for that target population – and Black and Brown people will continue to have the highest burden of disease and loss of life.

Finally, another missed opportunity here is that while well-intentioned, as a Black patient, I continue to see organizations making decisions and recommendations for marginalized populations without including patient populations at the creation process of such recommendations.?As we work to build trust in trials, we have to start at the beginning.?Include us in the development of the recommendations, not just ask us to give feedback to plans recommendations.?

At the end of the day, no matter how many buzzwords are used, policies enacted, panel discussions held, articles written or diversity commitments made, real, authentic change will come when Black and Brown communities who have not had representation and who have been disadvantaged no longer die at devastatingly disproportionate rates, even in the face of innovative programs and initiatives such as these, and that will only happen when we are at the table and the recommendations have teeth to them.