The diversity of patients participating in clinical trials continues to be a problem in drug development. As sponsors and sites attempt to address the problem, regulators are also doing their best to address the issue.
One person deeply involved in this issue is Rear Admiral Richardae Araojo, the associate commissioner for minority health and director of the Office of Minority Health and Health Equity at FDA. Araojo recently joined a diversity panel on Clinical Leader Live to discuss the responsibilities of her office and the steps it is taking to help create more diversity in trials.
The Office of Minority Health was established at FDA in 2010. In 2019, the name was changed to the Office of Minority Health and Health Equity. Araojo believes the name change helps highlight the scope of the work that the office has historically performed and will continue to do.
“We work to protect and promote the health of diverse populations by focusing our efforts in two key areas, which are research and outreach/communication to address health disparities. We work broadly across the agency, as well as working closely with our public and private sector stakeholders. A key priority area for us is working to advance the participation of racial and ethnic minority groups in clinical trials.”
The Need For Diversity
In drug development, clinical trials provide a crucial base of evidence for evaluating whether a medical product is safe and effective. For that reason, enrollment in trials should reflect the diversity of those who are ultimately going to use the product. Araojo notes that this is important because people of different ages, races, and ethnicities may react differently to certain medical products.
“We think it's important that clinical trial participants reflect those who are most likely to use the product so the data can be appropriately analyzed and meaningful information can be communicated to the public,” she says. “FDA has long worked to advance diverse participation in clinical trials from hosting public meetings, developing tools, issuing guidance documents, and highlighting some of the specific efforts of the office of minority health and health equity.”
Educating diverse communities and stakeholders is an important part of that effort. Several years ago, the Office of Minority Health and Health Equity established a Diversity and Clinical Trials Initiative which includes an ongoing multimedia campaign. The campaign focuses on raising awareness and education on clinical trials. The diversity initiative also works to provide educational materials and multimedia to help address some of the barriers preventing diverse populations from participating in clinical trials. This is done through a variety of culturally and linguistically competent strategies, tools, and resources. The overall goal is to ensure the tools and resources highlight what a clinical trial is, what it means to participate in a clinical trial, and why it is important for trials to have diverse participation.
An Effort To Educate
The Diversity and Clinical Trials Initiative has a variety of resources available on its website. There are fact sheets and postcards available in multiple languages that highlight the value of clinical trial participation. There are public service announcements and videos, and the office engages in social media outreach to encourage different groups to participate. Those social media messages are also available in multiple languages.
“We have ongoing outreach to engage different communities of health professionals working to raise awareness of trials,” says Araojo. “When you think about the barriers to participation, we know those barriers cross multiple sectors. It's important for us to make sure we have close collaborations, partnerships, and engagements across all of our stakeholders. We work with both public and private sector stakeholders. We also work across government and with academia and industry to educate consumers and communities about the importance of diverse participation in clinical trials.”
Education is an ongoing campaign, and FDA is always working to add new tools and resources. One of the resources recently added is a video on medical device clinical trials. The Office of Minority Health and Health Equity worked with FDA’s Center for Devices and Radiological Health to produce the video, which was released in November 2020. The video provides educational information on devices and device clinical trials, and also highlights the importance of diverse participation in device clinical trials.
Partnerships and collaborations are very important to Araojo, and she notes stakeholder engagement activities are an important part of them. The Office of Minority Health and Health Equity is working with the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and FDA. Araojo’s office also works with the Multi-Regional Clinical Trials Center (MRCT) of Brigham and Women’s Hospital and Harvard University on their diversity work group. There are other types of collaborations created through memorandums of understanding (MOUs). One is with the Yale School of Medicine, which gave Araojo’s office the opportunity to work with the Yale’s cultural ambassador program, an engagement of community partners that work to increase diverse participation in clinical research.
Another MOU, with the Alliance of Multicultural Physicians, has allowed the Office of Minority Health and Health Equity to engage with five of the major minority physician associations to continue to advance diverse participation in clinical research.
The Importance Of Community Engagement
Advancing patient diversity in clinical trials means overcoming barriers. To overcome barriers, there needs to be community engagement.
“We know one barrier is a lack of trust due to past historical abuses,” states Araojo. “Other barriers we hear about are the lack of awareness about what a clinical trial is and what it means to participate in one. When we can engage with the community, it offers opportunities for us to overcome those barriers. When we talk about community engagement, I think it's really important for us to remember that when we say this, we're thinking consistent and continued community engagement. We cannot step in for one trial and then step back out. We are working to build long lasting relationships with the community that can lead to trust.”
Community engagement can also raise awareness and provide the education that the public needs on clinical trials. Consistent and continued bi-directional community engagement is not about telling the community what you think they want to know. It involves working with the community to understand their knowledge of clinical trials and work to address any gaps. Araojo stresses working with cultural ambassadors and faith-based organizations, as well as with trusted leaders in the community. All those efforts, taken as a whole, will support and advance clinical trial diversity.
Finally, Araojo addressed successful strategies that might work to address the lack of diversity in trials.
“When you’re planning a trial, you're thinking about disease prevalence,” she says. “You will be thinking about epidemiology, and the fact that there is no one-size-fits-all approach. As you’re thinking about the disease or condition, you should be thinking about the populations that you are seeking to recruit. That thinking has led to strategies that we know worked to support clinical trial diversity and have led to success in that space.”
Most successful strategies are straightforward. First, Araojo suggests starting your planning early and having the target patient population in mind from the very beginning. Avoid eligibility criteria that is overly burdensome. Make community engagement a central part of that plan. Part of your planning process should also include engaging patients and patient advocacy groups.
“Engaging patients and advocacy groups regarding trial design, logistics, and recruitment and retention practices will help you design trials that avoid patient barriers,” adds Araojo. “I think sponsors should also not forget the importance of sites. Make sure your site locations are in areas where there is access to racial and ethnic minorities and that there are diverse study team staff. Site staff should be culturally competent and aware and sensitive to the needs of minority patients. Sponsors should attempt to engage with providers and do what they can to eliminate language barriers through translations or interpreters. Following these strategies will help you recruit a more diverse patient population.”