Today’s healthcare and biopharmaceutical organizations understand why engaging diverse patient populations in clinical research is essential. We recognize that disease epidemiology differs across populations, potentially impacting treatment safety and efficacy. The real question is, “How?” How can we ensure diverse and equitable representation in clinical trials while maintaining speed and efficiency?
It’s not an easy task. Every sponsor organization is at a unique place in its diversity journey. Even within organizations, it’s common to find that some departments and functionalities are further along the continuum than others. Consequently, there can be no one-size-fits-all approach. However, every sponsor can enhance their diversity initiatives by encouraging a culture shift in parallel with strategies designed to engage underrepresented populations.
Create a new mindset
There is no question about it: Speed means everything in clinical research. Every day that passes means patients must wait for better diagnostics or therapies.
Still, improving diversity, equity, and inclusion (DEI) in clinical studies is not a sprint. It’s a marathon that involves a great deal of learning, gap analysis, and discussion. So, we must reframe how we look at speed and efficiency.
For example, should we prioritize writing a clinical development plan and protocol quickly if the lack of upfront consideration creates recruitment and retention bottlenecks? Slowing down enough to incorporate DEI strategies at the very earliest stages of the drug development process—long before recruitment—will likely pay dividends over the long run. The benefits might include faster and more representative patient enrollment, higher patient retention, and more robust study data.
Sponsors can start changing the culture by bringing together communities of individuals who will, over time, build the partnerships necessary to increase clinical trial diversity. Leadership commitment is essential. In addition, sponsors should include the perspectives of investigators and other healthcare professionals at sites, as well as patient and community based groups. Doing so will help bring to light practical ways to “operationalize” DEI initiatives that speed and ease studies overall.
Operationalize engagement
Practical steps must be taken in parallel with the mindset shift to truly engage diverse patient populations. For instance, sponsors may have significant opportunities to increase outreach, education, and awareness within historically underserved communities. One published study indicated that more than 90% of Black and Latinx residents had never been approached about participating in clinical research, but 75% of them expressed willingness to participate if approached by organizations they trust.
Here are some tactical ways to raise clinical trial awareness, availability, and accessibility within diverse patient populations:
- Define “diversity” early in development. Diversity takes many shapes and forms—race, age, ethnicity, disabilities, sex, gender identity, pregnancy, individuals breastfeeding, etc. What diversity factors are relevant to the study at hand? Study teams should align on the definition of diversity for each study before crafting the clinical development plan and protocol.
- Build long-standing patient relationships. Engaging patient advocacy groups, advisory boards, and patients with lived experience early and often—not just when actively enrolling a study—is increasingly encouraged. The more we understand and empathize with patients’ perspectives, the faster we can design trials that better accommodate their needs.
- Ensure an inclusive protocol. Closely examine inclusion/exclusion criteria instead of using the faster tactic of simply copying the criteria used for similar studies. Consider assessing earlier criteria against screen failure rates for race, ethnicity, sex, etc. Are some Sexual Gender Minority (SGM) individuals unnecessarily excluded by hormone therapy, for example? Sponsors may want to consider whether AI could help quickly conduct preliminary assessments by evaluating the percentage of various populations that would be excluded if the protocol were written in different ways.
- Create informed consent documents in multiple languages simultaneously. Too often, patient enrollment begins before the IRB-approved English version of the informed consent is translated into other languages. With this type of design, these studies may delay the enrollment of patients whose first language is not English. Besides, it’s often quite apparent to patients when documents are translated into their language vs. written natively, which may make them feel that the study isn’t meant for them.
- Involve clinical sites within diverse communities. Site selection plays an enormous role in engaging diverse patient populations. Because sites are on the front line of patient recruitment, forming genuine partnerships with those in catchment areas, countries, or geographic regions that fit the study’s diversity definition is critical. Sponsors should hold study teams accountable for selecting a percentage of sites in diverse locations. Likewise, they should discourage repeatedly going to the same sites solely because they recruit large numbers of patients.
While it’s true that collaborating with research naive sites across diverse geographies demands additional upfront time, effort, and continuous support, the dedication to establishing study opportunities where none were available before can propel equity, expedite enrollment, and fortify the quality of study data. Choosing sites that mirror the demographics of the community they serve can help to cultivate trust within that community.
- Engage sites with diverse and multilingual investigators, coordinators, and staff. Where possible, staff should represent the diverse populations they serve in their community. Offering patients continual access to someone who understands the study in their language—and can discuss it with them and their families—may help improve access to clinical trials for historically underserved populations. Easier access may, in turn, make it easier and faster to recruit and retain diverse patient populations.
Speed, efficiency, and diversity
Bringing together individuals and organizations that want to enhance clinical trial diversification strategies takes time. Yet, by stepping back, we will see that achieving speed, efficiency, and diversity is possible. If we embed diversity into the very fabric of Clinical Drug Development, we will likely find it faster and easier to create studies that result in higher-quality therapies for everyone.
Catherine Ofori-Atta
Catherine Ofori-Atta is the Senior Clinical Operations Lead at Roche.
She works through TransCelerate BioPharma Inc., a non-profit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies.
The organization’s mission is to collaborate across the global biopharmaceutical R&D. All are welcome to use TransCelerate’s publicly available Diversity of Participants in Clinical Trials Initiative tools and information.
Sandra Amaro
Sandra Amaro is Head of Clinical Trial Diversity at Pfizer.
She also works through TransCelerate BioPharma Inc., a non-profit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies.
The organization’s mission is to collaborate across the global biopharmaceutical R&D. All are welcome to use TransCelerate’s publicly available Diversity of Participants in Clinical Trials Initiative tools and information.
