The COVID-19 pandemic sparked rapid innovation and adoption of new methodologies and practices across clinical trials. In addition, it allowed the planet to start to see the difficulty of ensuring diversity and usage of those trials — challenging we’ve faced for several years. Innovators in biopharma, life-science technology companies, and clinical research organizations (CROs) partnered with the FDA and health regulators all over the world to successfully meet this enormous challenge. But we have to keep our foot on the gas.
It is time to press ahead with meaningful, durable change — to codify the lessons we’ve learned through the COVID pandemic, amplify what worked, and harmonize the regulatory environment to market further progress.
We’re at a crucial inflection indicate continue making certain trials were created for the right population. Regulators established stronger guidelines round the need for clinical trial diversity and access — like the FDA, whose window for public comments recently closed on draft guidance to the effect. This guidance comes at a significant 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 again to early 2020: In just a matter of weeks, the pandemic prompted pharmaceutical companies and the CROs that partner using them to look at decentralized clinical trial (DCT) practices in large form — telehealth, remote data collection and diagnostics, at-home therapy administration, and much more. Subsequently, that helped spur more diversity. For instance, Moderna, which leveraged DCT solutions in the development of its COVID-19 vaccine, prioritized patient diversity to the stage of slowing enrollment in its trials. The effect? A commendable 37% of Moderna’s trial population originated from communities of color, a makeup much like the U.S. population most importantly.
Such prioritization and activation are badly needed more broadly. The decision for more diversity in clinical trials is hardly new, yet patient data indicates we still have quite a distance to go. An FDA report published in April on drug-trial populations figured “many programs [were conducted] where representation from certain racial and ethnic groups was low.”
Improving diversity in clinical trials can be an important solution to address medical needs of underserved communities and enhance patient outcomes. One step would be to examine diversity beyond the racial and ethnic lines emphasized in the FDA’s draft guidance. While that is clearly a good start, a lot more types of diversity exist, including geographic diversity, socioeconomic diversity, and beyond.
Another area needing continued focus is DCTs. Remote trials might help mitigate the logistical challenges developed by traditional trials, allowing patients to target more of these attention on the family, work, along with other responsibilities. Moderna is hardly the only real exemplory case of the rise in tech-enabled decentralization through the pandemic. Spurred by CROs and their technology partners, the engines that execute these trials, DCT adoption has garnered FDA support and soared in modern times.
We have to build on that progress: to see 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 most recent FDA guidance is really a commendable step, but we have to ensure the various tools we develop and the leadership we employ meet or exceed the purpose of helping patients. Types 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. Additionally more nuanced outreach, we ought to support more training for research sites and associated staffing to create physicians with original backgrounds and experience to a number of settings. Additionally, we have to leverage more data, like disease prevalence and patient location, to boost trial placement and increase availability to all or any communities. We have to urge sponsors and vendors to fully capture more patient insights and integrate the feedback into drug and device development. Finally, we should continue steadily to lower barriers to accessibility through long hours of operation, more virtual visits, along with other such practices.
Increasing diversity in clinical trials may be the right move to make, especially in underserved and under-recognized patient communities. Let’s continue steadily 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.
Medidata Solutions received client fees from Moderna for creation of a clinical trial platform.