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.

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