Diversity in Clinical Trials: Walking the Walk

By Sheila Omondi, Practice Lead, Clinical Planning and Strategy Consulting

Ensuring diversity in clinical trials is not just about talking the talk, it’s about walking the walk. At the Summit for Clinical Ops Executives (SCOPE) last month, it was evident that diversity in clinical trials remains a topic of discussion, even a decade after it first gained significant attention. It's time we ask ourselves why progress has been slow and whether we're truly innovating at the pace required to effect meaningful change. Achieving true diversity in clinical trials requires intentional and proactive efforts throughout the entire research process. Let’s now hear from industry leaders and trailblazers committed to taking concrete steps and addressing this issue head on.

10 challenges in recruiting diverse population

1. Awareness — of the protocol/sponsor/clinical trial space
2. Access — to the clinical sites (most sponsors have a preference for university/academic hospitals during feasibility and site selection, which eliminates a lot of the marginalized population)
3. Resources/logistical challenges — child and elderly care, food, transportation, time off work
4. Education and lack of understanding — about clinical trials in general
5. Mistrust — of the medical/pharmaceutical industry as a whole
6. Language and cultural competencies — create a safe space to ensure all concerns are addressed 
7. HCP engagement — some HCP are less receptive to sharing clinical trial options with patients; underserved patients often lack trust in their HCPs because of negative engagements with them and resist receiving clinical trial information
8. Complexity — of the trial and how to best communicate it
9. Representation in research — people are less likely to participate if the clinical trial staff does not look like them
10. Stigma and discrimination — for so long, populations such as the LGBTQIA+ community have been excluded from participation in clinical trials because they don’t meet binary gender criteria or exclusion criteria including pre-exposure prophylaxis (PrEP) for HIV prevention with no scientific backing elimination.

Where do we go from here? Start with the patient

Paula Nwajei, manager, Patient Engagement and Recruitment, ProKidney, says sponsors must always use a health equity lens when making clinical decisions. In her role at the biotech, Nwajei focuses on patient engagement and clinical trial diversity. When it comes to clinical trial diversity, she says one of the first things sponsors should consider during the protocol development phase is understanding epidemiological data related to the patient population. She says diversity should be a factor from the get-go, during the trial planning stage. By creating a patient journey to help understand barriers to care within the patient group, sponsors can avoid having to submit protocol amendments later. Nwajei says the goal should be pushing for a more patient-centric approach in clinical trial development.

Nwajei also recommends including patients as part of these processes to provide real-time data. Their feedback, she advises, should be incorporated when developing the protocol (patient burden, fears, and understanding of the protocol itself). This goes for patient-facing material such as the informed consent form as well. Is it relatable? Is it concise? Is it easy to understand (aim for a third- to eighth-grade reading level)? Are there any gaps that should be addressed regarding the patient/caregiver? She says patient feedback should not stop with the protocol; sponsors should establish a process to receive continuous and real-time feedback. This helps the study team “become” the patients and better serve them, Nwajei says. Nwajei notes that keeping patients engaged throughout the process allows for sponsors to understand the nuances/cultural/socioeconomic implications that may otherwise be overlooked. Engagement with grassroots patient advocacy groups increases understanding and awareness of the clinical trial space.

Sponsors would be wise, Nwajei says, to move from a site-identification approach to more of a patient-identification approach. In other words, meet patients where they are. She reminds that not all patients have access to the investigators that sponsors choose. Ways sponsors can increase access to a study, she says, is by creating hub-and-spoke models, decentralized clinical trials ( in countries where permitted), and partnerships with community hospitals. She adds that this barrier also can be bridged by increasing community engagement. Sponsors’ presence among religious groups and at recreational centers, for instance, can go a long way toward building trust in ― and their understanding of ― these communities.

Just as it is important to continuously collect feedback, Nwajei says that keeping patients engaged throughout the process boosts retention. On an individual level, she says participants feel valued when they receive personalized messages (which can be automated), such as birthday greetings, remembering special life events, and engaging one-on-one during visits. On a global scale, she notes, sponsors can harness digital media to push awareness.

Building trust while keeping ethics and regulations in mind

Sponsors must possess a high level of cultural competence in order to build trust in underserved communities. They should know and understand how people of various demographic groups want to receive information, says Dezbee McDaniel, cofounder/CEO of CliniSpan Health. CliniSpan uses AI-driven influencer matching technology to promote patient education and engagement.McDaniel emphasizes that “nothing works in today’s world of marketing without the integration of social media platforms, and that is true for patient education and engagement as well.

Ethical considerations for leveraging social influencers, however, are centered on information sharing and data privacy. These are universal industry concerns, regardless of the medium. Another red flag regarding social media is the sheer amount of misinformation shared. Sponsors must carefully choose communication partners to ensure the accuracy of information. Failure to do so will erode the trust they have worked so hard to develop within patient communities.

McDaniel says social media is not highly regulated industry wide, but more stringent regulation is on the horizon. That means it is up to sponsors and their recruitment partners to set specific guidelines on how to share content and how to engage the public.

In conclusion

Sponsors seeking to recruit trial participants from marginalized communities must first earn their trust. To do this, they must elicit feedback from patients and then act upon that input. They must ensure that their study teams are diverse, reflecting the target population and providing a certain level of comfort. They must immerse themselves in these communities to learn communication preferences, address challenges to participation, and understand cultural nuances that could impact the decision to join a clinical trial.