Keep Our Foot on the Gas for Clinical Trial Diversity

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The COVID-19 pandemic sparked rapid innovation and adoption of new methodologies and practices across clinical trials. It also allowed the world to see the difficulty of ensuring diversity and access to those trials — a challenge we’ve faced for many years. Innovators in biopharma, life-science technology companies, and clinical research organizations (CROs) partnered with the FDA and health regulators around the world to successfully meet this enormous challenge. But we need to keep our foot on the gas.

It’s time to press ahead with meaningful, durable change — to codify the lessons we’ve learned during the COVID pandemic, amplify what worked, and harmonize the regulatory environment to promote further progress.

We’re at a critical inflection point to continue ensuring that trials are designed for the correct population. Regulators have established stronger guidelines around the importance of clinical trial diversity and access — including the FDA, whose window for public comments recently closed on draft guidance to this effect. This guidance comes at an important moment. The pandemic illuminated the disparate health outcomes faced by marginalized communities, while also spawning major strides in patient diversity for clinical trials, a development that benefits both patients and research efficacy.

Think back to early 2020: In a matter of weeks, the pandemic prompted pharmaceutical companies and the CROs that partner with them to adopt decentralized clinical trial (DCT) practices in large form — telehealth, remote data collection and diagnostics, at-home therapy administration, and more. In turn, that helped spur more diversity. For example, Moderna, which leveraged DCT solutions in the development of its COVID-19 vaccine, prioritized patient diversity to the point of slowing enrollment in its trials. The result? A commendable 37% of Moderna’s trial population came from communities of color, a makeup comparable to the U.S. population at large.

Such prioritization and activation are badly needed more broadly. The call for more diversity in clinical trials is hardly new, yet patient data indicates we still have a long way to go. An FDA report published in April on drug-trial populations concluded that “many programs [were conducted] where representation from certain racial and ethnic groups was low.”

Improving diversity in clinical trials is an important way to address the health needs of underserved communities and enhance patient outcomes. One step is to examine diversity beyond the racial and ethnic lines emphasized in the FDA’s draft guidance. While that’s a good start, many more forms of diversity exist, including geographic diversity, socioeconomic diversity, and beyond.

Another area needing continued focus is DCTs. Remote trials can help mitigate the logistical challenges created by traditional trials, allowing patients to focus more of their attention on their family, work, and other responsibilities. Moderna is hardly the only example of the rise in tech-enabled decentralization during the pandemic. Spurred by CROs and their technology partners, the engines that execute these trials, DCT adoption has garnered FDA support and soared in recent years.

We need to build on that progress: to inform and educate, build trust among marginalized communities, expand reach, and advocate for DCTs among stakeholders. And we still need additional harmonization between different bodies here and abroad, from the FDA to the European Medicines Agency.

The latest FDA guidance is a commendable step, but we need to ensure the tools we develop and the leadership we employ meet or exceed the goal of helping patients. Examples of what’s needed include enhancing the promotion around ClinicalTrials.gov, especially to diverse audiences, and adding education and outreach that’s sensitive to culture and language. Along with this more nuanced outreach, we should support more training for research sites and associated staffing to bring physicians with unique backgrounds and experience to a variety of settings. Additionally, we should leverage more data, like disease prevalence and patient location, to improve trial placement and increase availability to all communities. We should urge sponsors and vendors to capture more patient insights and integrate the feedback into drug and device development. Finally, we must continue to lower barriers to accessibility through extended hours of operation, more virtual visits, and other such practices.

Increasing diversity in clinical trials is the right thing to do, especially in underserved and under-recognized patient communities. Let’s continue to press forward rapidly, safely, and collaboratively.

Jackie Kent, BS, is chair of the Association of Clinical Research Organizations and executive industry advisor at Medidata Solutions.

Disclosures

Medidata Solutions received client fees from Moderna for creation of a clinical trial platform.

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