The global COVID-19 pandemic shone a bright light on the need for healthcare systems and communities to work for the benefit of all.

What steps are being taken by clinical researchers, the industry sponsors of that research, and the Agency regulating that research to ensure more equitable healthcare in the US, from bench to bedside?

FDA Frameworks

Two years later, Section 907 of the FDA Safety & Innovation Act of 2012 specifically directed the Agency to report on inclusion of these demographic subgroups in clinical trials, data analyses, and approval applications for drugs, biologics, and medical devices. In response, the FDA developed Drug Trial Snapshots that analyzed clinical trial participation and safety and effectiveness data by demographic subgroups. By identifying gaps in study enrollment, these snapshots have helped drive more complete and representative trial recruitment.

FDA’s focus on diversity and inclusion in clinical research continued to ripple through subsequent guidance to industry. Issued in 2016, Data Collection from Relevant Populations reinforced FDA’s expectations that sponsors would enroll clinically relevant populations with regards to gender, race, age, or ethnicity, in their trials. This concept was subsequently supported and refined by Evaluation of Age-, Race- and Ethnicity-Specific Data (issued in 2017); and Enhancing Diversity of Clinical Trial Populations (2020).

Clinical research conducted during the frantic aftermath of the first wave of COVID-19 highlighted the need for better and more frequent communication between the overall healthcare system (including research) and patients of every demographic, and the concepts of diversity and inclusion were embedded in FDA’s guidance to industry on drug and biologic clinical research and development, and vaccine research and development, in the pandemic’s wake.

Community Foundations

Working to ensure that trial sites bring the research to the communities that the research is trying to serve is one basic first step. This can mean locating your site in a community neighborhood, but it can also include employing study staff who represent, can be trusted by, and know how to engage with that community. Developing new sites is worthwhile, but so is encouraging (and perhaps incentivizing) your existing sites to better understand and communicate with these communities with genuine sincerity for their well-being.

Where are patients in these communities going for healthcare? Working with these same healthcare providers will engender experience with and access to these communities – and trust in your research as a complement or new option to their regular or routine care.

Sponsors can plan ahead for diversity by including in their study budget allocations for transportation and translation. Diverse populations can work different types of jobs and have different family or social obligations, often on different schedules. A transportation allowance may help some patients visit the clinic earlier (before) or later (after), and still manage to meet their work or family obligations. Language translation, not only of print materials but of software or device download instructions, is no longer a luxury – it is a must. Enrolling diverse study populations will almost ensure that at least one patient can read and comprehend their informed consent only in their native language.

The investigator’s kickoff meeting is another opportunity to stress the epidemiology of the disease, its relative burden in different subpopulations, and the expectations that these subpopulations will be enrolled in the trial to generate appropriate data for analysis. Providing enrollment benchmarks (or even incentives) for these subpopulations based on this epidemiology has proven helpful.

The global rise of expedited or accelerated regulatory review processes, including emergency use authorizations for COVID-19 products, have recently stimulated new discussions about how the post-market setting has opened a new frontier to further pursue diversity and inclusion in healthcare.

COVID-19 has taught many important if difficult lessons. The global healthcare community has learned that significant healthcare issues can no longer be contained by or within manmade borders or barriers. Sponsors are exploring more deeply the connection between good communication with diverse subpopulations about clinical trials, their participation in these trials, and more successful product launches in these subpopulations. And researchers continue to learn that the best place to meet underserved and underrepresented communities is right where they already are.