The COVID-19 pandemic has triggered rapid innovation and adoption of new methodologies and practices in clinical trials. It also allowed the world to see the difficulty of ensuring diversity and access to these trials – a challenge we have faced for many years. Biopharmaceutical innovators, life science technology companies, and clinical research organizations (CROs) have partnered with the FDA and health regulators around the world to successfully address this massive challenge. But we have to keep our foot on the accelerator.
It’s time to move forward with meaningful and lasting change – to codify the lessons we’ve learned during the COVID pandemic, amplify what has worked, and harmonize the regulatory environment to promote new ones. progress.
We are at a critical inflection point to continue to ensure trials are designed for the right population. Regulators have established stricter guidelines regarding the importance of diversity and access in clinical trials, including the FDA, whose public comment window recently closed on draft guidelines to that effect. This guidance comes at an important time. The pandemic has shed light on the disparate health outcomes faced by marginalized communities, while driving major advancements in patient diversity for clinical trials, a development that benefits both patients and the effectiveness of the research.
Think back to early 2020: Within weeks, the pandemic prompted pharmaceutical companies and the CROs that partner with them to adopt large-scale decentralized clinical trial (DCT) practices: telehealth, data collection, and diagnostics at distance therapy, home therapy administration, and more. This, in turn, has helped stimulate more diversity. For example, Moderna, which leveraged DCT solutions in the development of its COVID-19 vaccine, has prioritized patient diversity to the point of slowing recruitment into its trials. The result? A commendable 37% of Moderna’s test population came from communities of color, a composition comparable to the US population as a whole.
Such prioritization and activation is badly needed more broadly. The call for more diversity in clinical trials is not new, but patient data indicates that 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 the representation of certain racial and ethnic groups was low.”
Improving diversity in clinical trials is an important way to meet the health needs of underserved communities and improve patient outcomes. One step is to look at diversity beyond the racial and ethnic lines outlined in the FDA’s draft guidelines. While this is a good start, many other forms of diversity exist, including geographic diversity, socio-economic diversity and beyond.
Another area requiring continued attention is that of CSDs. Remote trials can help alleviate the logistical challenges created by traditional trials, allowing patients to focus more of their attention on family, work, and other responsibilities. Moderna isn’t the only example of the increase in tech-enabled decentralization during the pandemic. Spurred by CROs and their technology partners, the engines that run these trials, DCT adoption has gained FDA support and has soared in recent years.
We must build on this progress: to inform and educate, build trust among marginalized communities, expand reach and advocate for CSDs with stakeholders. And we still need further harmonization between different agencies here and abroad, from the FDA to the European Medicines Agency.
The latest FDA guidelines are a laudable step, but we need to make sure the tools we develop and the leadership we employ meet or exceed the goal of helping patients. Examples of what is needed include improving promotion around ClinicalTrials.gov, especially to diverse audiences, and adding culturally and language sensitive education and awareness. . Along with this more nuanced outreach, we should support more training for research sites and associated staff to bring in physicians with unique backgrounds and experience in a variety of settings. Additionally, we should leverage more data, such as disease prevalence and patient location, to improve trial placement and increase availability for all communities. We should urge sponsors and suppliers to collect more patient information and incorporate feedback into drug and device development. Finally, we must continue to reduce barriers to accessibility through extended hours of operation, more virtual tours, and other similar practices.
Increasing the diversity of clinical trials is the right thing to do, especially in underserved and underrecognized patient communities. Let’s keep moving forward quickly, safely and collaboratively.
Jackie Kent, BS, is President of the Association of Clinical Research Organizations and Executive Industry Advisor at Medidata Solutions.
Medidata Solutions received fees from Moderna for creating a clinical trial platform.