The COVID-19 pandemic has sparked rapid innovation and adoption of new methods and practices in clinical trials. It has also shown the world how difficult it is to ensure diversity and access to these trials – a challenge we have faced over the years. Innovators in biopharmaceuticals, life science technology companies, and clinical research organizations (CROs), working with the FDA and health regulators around the world, have successfully tackled this formidable challenge. But we need to keep our feet on the ground.
Time to move forward with meaningful, lasting change – codifying the lessons we’ve learned during the COVID-19 pandemic, amplifying what works, and harmonizing the regulatory environment to facilitate further progress.
We are at a critical inflection point and need to continue to ensure trials are designed for the right population. Regulators have developed stronger guidance around the importance of diversity and access to clinical trials — including the FDA, whose public comment window recently closed for draft guidance on this. This guidance comes at an important time. The pandemic has revealed disparate health outcomes facing marginalized communities, while also bringing about major advances in patient diversity in clinical trials, a development that benefits both patients and research efficiency.
Recall early 2020: In a matter of weeks, the pandemic spurred pharma companies and the CROs they work with to adopt large-scale decentralized clinical trial (DCT) practices – telemedicine, remote data collection and diagnosis, family therapy management, etc. This, in turn, helps stimulate more diversity. For example, Moderna, which leverages DCT solutions when developing a COVID-19 vaccine, prioritized patient diversity to the point of slowing enrollment in its trials. result? To its credit, 37% of Moderna’s trial population is from communities of color, a composition comparable to the overall U.S. population.
This prioritization and activation is urgently needed more broadly. Calling for more diversity in clinical trials is nothing new, but patient data suggest we still have a long way to go. An FDA report on drug trial populations, released in April, concluded: “[Conducted] many programs that are underrepresented by certain racial and ethnic groups.”
Increasing the diversity of clinical trials is an important way to address the health needs of underserved communities and improve patient outcomes. One step is to examine the diversity beyond racial and ethnic boundaries highlighted in the FDA’s draft guidance. While this is a good start, more forms of diversity exist, including geographic diversity, socioeconomic diversity, and more.
Another area that requires ongoing attention is DCT. Remote trials can help alleviate the logistical challenges posed by traditional trials, allowing patients to focus more on their family, work and other responsibilities. Moderna isn’t the only example of tech-enabled decentralization rising during the pandemic. Driven by CROs and their technology partners (the engines that execute these trials), DCT adoption has gained FDA support and has skyrocketed in recent years.
We need to build on this progress: inform and educate, build trust among marginalized communities, expand reach, and advocate for DCT among stakeholders. We still need additional coordination between different agencies at home and abroad, from the FDA to the European Medicines Agency.
The latest FDA guidance is a laudable step, but we need to ensure that the tools we use develop and the leaders we hire meet or exceed our goals of helping patients. Examples of what needs to be done include increased advocacy for ClinicalTrials.gov, especially for diverse audiences, and increased cultural and language-sensitive education and advocacy. In addition to this more nuanced outreach, we should support more training of research sites and associated personnel to bring physicians with unique backgrounds and experiences into a variety of settings. In addition, we should leverage more data, such as disease prevalence and patient location, to improve trial placement and increase availability in all communities. We should urge sponsors and providers to gain more patient insights and integrate feedback into drug and device development. Finally, we must continue to lower accessibility barriers through extended operating hours, more virtual visits, and other such practices.
Increasing the diversity of clinical trials is the right thing to do, especially in underserved and underrecognized patient communities. Let’s continue to move forward quickly, safely, and collaboratively.
Jackie Kent, BS, President of the Association of Clinical Research Organizations and Medidata Executive Industry Consultant Solutions.
DISCLOSURE
Medidata Solutions received Moderna’s client fee for the creation of the clinical trial platform.
