Lack of diversity in traditional clinical trials
Underrepresentation in clinical trials presents serious challenges to public health.
By Curebase
According to the 2021 U.S. Census Bureau, Non-Hispanic Whites represent 75.8% of the U.S. population, Hispanic/Latinos represent 18.9%, and Black/African Americans represent 13.6%. Yet, according to the FDA 2020 Drug Trial Snapshots, on average, Non-Hispanic Whites comprise 75% of traditional trial participants, while Hispanic/Latinos comprise only 11% and Black/African Americans comprise only 8% of participants.
Recent guidance by the FDA emphasizes the importance of trial participants accurately reflecting the real-world population in an effort to ensure that all are properly represented in clinical research. Otherwise, any conclusions may portray a skewed public health message that can further healthcare inequities. A decentralized approach to clinical research leads to greater diversity in clinical trial participation by using local, virtual, and at-home care models.
Across our partnerships, clinical trial makeup has had up to 50% more Non-White participation, including up to 67% more Black/African American participation. This can be attributed to the fact that decentralizing clinical trials addresses major obstacles to equity and access by removing barriers for patients such as geographic location, distrust of healthcare systems, accurate collection of patient symptoms, pain points, and outcomes, and much more.
Removing geographic barriers for patients in healthcare through virtual trial sites
Most traditional clinical trials are run at hospitals, academic research centers, or universities, therefore only people with the ability to get to the facility can participate. Many trials also involve frequent visits to the physical site location. This requires participants to afford numerous trips on private or public transportation or live within a commutable distance. Obviously, this prevents many patients from participating and providing valuable data. Incorporating virtual clinical trial site models allows researchers to expand patient access to these trials.
With this model, patients across the globe can contribute to the same study without leaving their homes or traveling further than their local urgent care or physician’s offices. Concurrently, researchers can gain key insights into how different lifestyles and environments influence health and medication effectiveness – this type of data can also be a key element to understanding and fighting against disparities and inequities in the healthcare ecosystem.
Building patient-provider relationships
As we have seen quite clearly with the rollout of the Covid-19 vaccine, many people are wary of the American healthcare system. The Tuskegee Study, for instance, is one example of historic abuse of minority groups causing ongoing generational trauma. To overcome this systemic issue, patients need to feel that they can trust the clinicians collecting their data and developing their treatment plans.
Utilizing patient-centric software designed to help providers focus on building patient relationships, physicians become researchers just by treating the patients they see every day. Not only does the physician-centric model encourage diversity in trial participants but it also provides opportunities for patients who might not otherwise hear about clinical trials.
Represent the underrepresented with us
While underrepresentation in clinical trials continues to be an issue, there is a general consensus among the life sciences community that we need a transformation. But how do we make sustainable and meaningful change? At Curebase, we recognize that decentralized clinical trials are the future of R&D. Every day, we are innovating and improving access for physicians, patients, and researchers.
We are on a mission to ensure every patient can participate in cutting-edge medical research. We believe that including patients with varying backgrounds, experiences, and identities in clinical trials is essential for advancing healthcare. Decentralizing clinical trials can address healthcare disparities across race, gender, and ethnicity by increasing equitable access and broadening the representation of clinical trial participants while collecting quality real-world data.
Read more about diversity in clinical trials: Supporting Women’s health: Addressing gender disparities in clinical trials
