By Irene Yeh
Jul 11, 2023
Diversity in clinical trials plays a key role in determining the effectiveness of new medications and treatments. However, clinical trials have proven that participant pools are not as diverse as they should be. At the IQVIA Institute, a 2022 report found that there has been a significant decrease in participants during Phase II and III of completed clinical trials over the past decade, mainly among the African American and Hispanic American communities. The number of African American participants in clinical trials was as high as 80-90% of US demographic levels in 2018, but fell to only about 50% of demographic levels in 2021. For Hispanic American participants, the fluctuation has not been as distinct; Hispanic patients were enrolled in trials at 53% of U.S. demographic levels in 2022.
But there have been changes in the right direction. At the end of 2022, the FDA’s latest Food and Drug Omnibus Reform Act (FDORA) was approved. With this new policy, clinical trials are now obligated to fulfill diversity requirements, such as recruiting, enrolling, and retaining participants from underrepresented racial and ethnic groups, as well as other demographic groups. FDORA is the next step to reducing disparities and helping patients more easily access the care and medications they need.
While diversity efforts are improving, it still takes the entire clinical development field to keep the momentum going. So, what can clinical research organizations do to make sure these disparities are reduced and to ensure more diverse pools of participants? On the latest episode of The Scope of Things podcast, host Deborah Borfitz discusses the report findings and next steps with Murray Aitken, Executive Director of the IQVIA Institute.
Sites and Staffing
Two crucial players that can help expand participant pools are the research sites and their staff members. IQVIA conducted a series of interviews with sites that are stepping up to the plate about diversifying not only their participants but also their staff members. They found that patients generally feel more assured and trusting toward the research team if they see diverse team members.
“A patient’s trust stems from the experience they have from the site’s study team,” explains Aitken. “If a patient observes a racially-diverse staff that are cooperating and respecting one another as they work together, patients of color may expect the same treatment as a result.”
This also extends to the passion of the staff. “Bringing in staff that are representative of the local community and are passionate about patient care—that is what comes through and helps the patient feel assured and trust the system,” continues Aitken.
Keeping an Eye on the Bigger Picture
While race and ethnicity are important aspects of diversity, there are other demographics that must be considered. Biological sex and gender are also factors that contribute to diversity. In trials for therapeutics, there is not enough attention being given to women who are affected differently or women who may have a different response to the therapeutic. Age is another factor. Many patients over the age of 65 receive medicine that has been trialed on patients younger than 65, which presents concerns over whether a certain medication is suitable for that particular age group. But perhaps the most prominent factor is socioeconomic status and background, which can be reflected in limited access to resources, including transportation, healthcare, and medical treatment.
The Future of Clinical Trials
“We’ve definitely turned a corner with this issue since the pandemic highlighted the stark disparities in COVID-19 outcomes among different racial and ethnic groups,” says Aitken.
While FDORA has helped clinical trials and researchers take the necessary steps to enroll and retain a more diverse participant pool, there is still much more work that needs to be done. “I think it’s fair to say there has been more public commitments and public statements of intent than there has been documented progress.”
But the future seems hopeful. With the new policy, clinical trials are expected to follow guidelines that will provide a more acute look into the effects of certain medications and treatments for specific demographics. If a trial does not meet the correct requirements, then it can be rejected, which can delay a trial from starting. FDA regulators are also allowed to issue response letters and post-approval commitments linked to a lack of diversity. These delays can have real impacts on the uptake of new medicines and affect business consequences in the long term.
“Fundamentally, it comes back to designing and executing clinical trials that include study participants who are representative of the patients who will ultimately be treated with that medication,” says Aitken. “That’s the core of the issue.”
As clinical trials continue to improve enrollment and retention, it is up to those who work in the clinical trial field to maintain the momentum and to keep doing better, trying new things, listening more, and investing in the right factors.