Embracing diversity in psychiatry and neurology clinical trials

There is broad recognition of the need to promote diversity and inclusion in clinical trials, with the goal of improving health equity and enhancing the validity and generalisability of study findings. This goal will require earning and building trust, promoting fairness, and generating biomedical knowledge.

Diversity is the focus of the draft guidance from the US Food and Drug Administration (FDA), entitled, “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry.” The draft guidance requires drug manufacturers to submit diversity action plans for phase 3 and other pivotal trials. Goals are required to be disaggregated by age, sex, and racial and ethnic demographic characteristics of clinically relevant populations. This builds on the FDA’s 2020 guidance on clinical trial diversity, “Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry.”

Sponsors wishing to enhance diversity in their psychiatry and neurology clinical trials should consider working with a partner with expertise in these areas. Multiple strategies at clinical research site level have been shown to help promote participation from underrepresented populations. Eight strategies to boost diverse recruitment include:

• Patient engagement in early-phase in-patient studies: For early-phase in-patient clinical trials, both recruitment and retention pose challenges. These trials may last for several months – for example, a recent study of a GLP-1 weight loss drug lasted 111 days – requiring participants to be able to tolerate long periods of time at a facility. The typical profile of a successful participant is someone who can entertain themselves, is generally laid-back and low maintenance, and perhaps enjoys online engagement such as gaming, shopping, or watching movies.
  Patient liaisons at the site play a vital role in retention, helping to tailor available activities to suit individuals. Medical teams are also important players, helping to manage any adverse events that may threaten retention. Factors to consider include the need for strong relationships between site staff and participants, to build a sense of inclusion and belonging, which in turn can lead to site loyalty and participation in multiple trials. The period when study participants are at the facility provides an opportunity for education about clinical research and future studies.
• Culturally-competent care: Ongoing training should be provided for site staff on cultural competence, implicit bias awareness, and best practices for recruiting and retaining diverse participants. Culturally sensitive care and language assistance should be provided, with documents and verbal communications in Spanish and other languages as needed. This will help ensure that participants feel comfortable and engaged throughout the research process.
  Cultivating a sense of belonging for participants is an important part of these efforts. In 2022, a study of patients with psychotic disorders found that, compared with their Caucasian counterparts, individuals from racial minorities particularly valued site staff courtesy and respect and took these into account in their decisions to enrol and continue participating in studies. Remembering to thank study participants is also an important step in building trust and loyalty to the site.
• Recruiting participants from earlier studies: For example, vaccine studies, with their large number of participants, are often the first type of clinical trial that participants experience. A positive experience with a vaccine trial – where the site staff build trust with study participants – can help build a site’s database of minority populations for future trials.
• Flexible study design, including providing transportation: This can help with recruiting individuals who face challenges in travelling to sites; for example, those who live in inner cities and do not have cars, or those without easy access to public transportation. Offering pick-up and drop-off to individuals within a 60-mile radius of the site has been found to support diverse recruitment, along with reimbursement of train tickets for those living further away. Flexible visit schedules and childcare support can also be helpful for underserved populations.
• Peer-to-peer referral programmes: Programmes where current study participants or interested community members refer others to clinical studies form the basis of peer-to-peer referral programmes, which are supported via materials such as ‘refer-a-friend’ business cards and brochures providing lists of indications currently being studied. Study coordinators and raters are particularly active in these programmes, leveraging their involvement in taking family medical histories from participants to identify family members who may also have target neurological diseases and be interested in clinical studies.
• Community outreach: This involves engaging with local communities to raise awareness about clinical research opportunities and address misconceptions or concerns about participation. Community ambassadors are another way to reach out into communities to support recruitment, developing long-term relationships and seeking out speaking engagements at local functions. Personal recommendations from trusted sources within the community can be particularly effective in encouraging participation among underrepresented groups. Endorsement from community leaders can also be helpful in building credibility and trust in clinical research, encouraging more individuals to consider participation.
• Targeted marketing and messaging: This includes developing culturally appropriate marketing materials and messaging that resonate with diverse populations. This may involve using imagery and language that reflects the diversity of the community and highlighting the potential benefits of participation in a way that is relevant to different demographic groups. Targeted advertisements may be placed in local publications for ethnic minorities, including immigrant communities, as well as outreach through churches and their publications.
• Patient advocacy groups: Sites can partner with patient advocacy groups that represent specific demographic or disease-specific populations. These groups can help identify potential participants, provide support and resources, and advocate for the needs of their members within the research process.

These learnings were derived from extensive study experience. In one example involving sickle cell disease, which is particularly prevalent in African Americans, CenExel was tasked with recruiting 40 study participants in around 14 days. The sponsor specified that this should include at least 25% African Americans. Ultimately, CenExel recruited 77.5% (31 out of 40 patients) African Americans. All 40 participants completed the 4.5 month-long study.

In a second example, the sponsor asked CenExel to enrol 39 subjects with a focus on females, who are traditionally harder to enrol due to the potential for childbearing. Following extensive efforts to screen more females, CenExel succeeded in enrolling 25 (64%) females and 14 (35%) males to the study. Of the 39 people enrolled, 36% were African American, 28% Latino/Hispanic, and 21% Caucasian.

Conclusion

By implementing these strategies, clinical trial sites can help overcome barriers to participation and promote diversity and inclusion in research studies. In fact, an example of successful recruitment of diverse populations showed 33% enrolment of African Americans, 28% Caucasian, 26% Hispanic, and 13% Asian and other minorities. Ultimately, by embracing diversity as a strength and making inclusivity a priority, we can ensure that clinical trials reflect the full spectrum of human diversity and lead to better health outcomes for all.