By Catherine Ofori-Atta and Sandra Amaro

Engaging diverse patient populations is essential to clinical research for many reasons, including:

● Disease epidemiology. We know there are biological differences in how various diseases impact different individuals. If we’re not reaching those populations that could benefit the most from the medicines, vaccines and/or devices being researched, we’re doing a disservice to those communities.
● Safety and efficacy data. It is important to assess the effect of potential therapies and devices within a controlled research environment. Failing to reflect diverse populations in clinical trial data may prevent their safe roll-out and limit their efficacy within specific populations.

Still, efforts to increase diversity, equity, and inclusion (DEI) in clinical trials often encounter barriers. In many cases, this is because of a longstanding—and necessary—emphasis on drug development speed. After all, the longer it takes to get a trial up and running, the longer patients must wait for much-needed treatments. Therefore, given the need to launch studies as quickly and safely as possible, diversity strategies historically are not incorporated until the recruitment stage.

This traditional approach seldom results in optimal representation of underserved populations. One study, for example, suggested that although 75% of Black and Latinx residents were willing to participate in clinical research that was conducted by entities they trust, more than 90% of them had never been asked about it. Such oversights often add time and complexity to patient recruitment—even though sponsors are also pressured to reduce recruitment cycle times.

With that in mind, sponsors should consider the downstream benefits of incorporating diversity into studies before the clinical development plan takes shape. Doing so might stretch early timeframes, but it could generate faster enrollment by opening research options to populations for the first time. Opening new demographics and geographies to clinical research can help advance not only diversity but equity as well.

Integrate diversity into operations
So, in a culture where speed is critical, how can sponsors achieve it in conjunction with quality and diversity? Here are five practical ways to “operationalize” diversity initiatives through patient engagement strategies:

1. Reinforce genuine patient relationships. As an industry, we can all do a better job of building deeper relationships with patient advocacy groups, advisory groups, and patients themselves. It’s not enough to engage diverse communities only when studies are open. Rather than transactional relationships, sponsors should commit to raising education and awareness of clinical research in general. They should empathize with patients as real people with real lives—not just their diagnoses. By working to understand patients’ challenges and accommodate their needs, sponsors can establish greater trust over time.

Trust, of course, is essential to any clinical trial’s success. Without it, patients will not enroll. Yet, mistrust caused by historical injustices is very real within some communities. Sponsors must be prepared to acknowledge history, have candid and sensitive conversations, and apologize when necessary to dispel any myths and overcome skepticism.

Additionally, educating communities on the measures in place today, such as Institutional Review Boards (IRBs) and Informed Consent, which are designed to safeguard patient safety and ensure informed participation, can further bolster trust and confidence in the clinical trial process.

2. Define diversity. Race and ethnicity are arguably the two most recognized forms of diversity. However, sponsors may need to think about other diversity factors such as age, (dis)abilities, sex, gender identity, pregnancy, and individuals breastfeeding. Study teams should carefully determine which diversity factors are relevant to their study and then use that insight to write the clinical development plan and protocol that supports inclusive behavior for these groups.

3. Write more inclusive protocols. It’s common practice to utilize I/E criteria from previous protocols for the same product or indication. However, sponsors should discourage this shortcut in favor of continually scrutinizing previously used criteria against reasons and rates for screen failures for diverse populations. AI tools could potentially make the process faster by showing who would be excluded by different versions of the protocol.

One critical aspect of inclusivity often overlooked is the gendering of protocols. Historically, clinical trial protocols have been framed in binary terms, which can inadvertently exclude Sexual Gender Minorities (SGM). By de-gendering protocols, sponsors can ensure that all individuals, regardless of their gender identity, feel acknowledged and included in the trial process.

In addition to writing more inclusive protocols, a review of real-world data may show which trial designs are most effective at reducing barriers for desired populations. Could transportation challenges be alleviated through decentralized or hybrid models, for example?

4. Look at language. Language barriers are a key deterrent to clinical trial diversity. Once again, however, they may be overcome if tackled early.

Instead of enrolling mainly English-speaking patients first, and then later “catching up” with patients whose first language is not English, sponsors may consider creating multilingual informed consent documents at the same time the English version is created. While there is some risk involved with IRB approvals and cost, the benefit is that sites can begin enrolling English- and non-English-speakers at the same time. Where possible, it can be beneficial to provide patients with access to site staff who both understand the study and speak their language. Patients who can read about and discuss their clinical trial options in their native language are more likely to be engaged and less likely to feel like a study “afterthought.”

5. Be intentional about investigator site selection. Nurturing long-standing relationships with community sites is as essential as deepening patient relationships. Indeed, sites that both serve and reflect diverse communities are the only way to reach those communities. Therefore, sponsors should be prepared to offer transparency and support to investigator sites, especially if they lack experience with clinical trials. This can be done by:

● Committing to continuous conversations with the sites.
● Helping to build capabilities and capacity within inexperienced sites.
● Being transparent about the kinds of patient populations the study team hopes the site can recruit. Diversity of Participants in Clinical Trials Solutions
● Holding sites to the same diversity and equity standards as the sponsor organization.
● Conduct DEI training for sites on topics like implicit bias and inclusive behaviors.

The time is now
Waiting until enrollment begins to engage diverse populations is not an effective way to make clinical trials more diverse, equitable, and inclusive. Diversity must be an integral part of each study’s strategy—defined and entwined into the end to end Clinical Development Lifecycle. More importantly, it must be part of a culture shift that prioritizes long-term relationships as much as speed and quality. However, if we take these steps, we can move toward a more seamless integration of speed, quality, and diversity in our clinical trial ecosystem.

About the authors: Catherine Ofori-Atta is the senior clinical operations lead at Roche. Sandra Amaro is head of clinical trial diversity at Pfizer. Catherine and Sandra collaborate on diversity strategies 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.