Three ways to increase patient diversity in clinical trials
Safe and effective treatments for all are only possible if there is patient diversity in the clinical trials of those treatments
Otis Johnson, Ph.D., M.P.A. – Chief Diversity, Inclusion, and Sustainability Officer at Clario
Each year, clinical trials deliver dozens of life-saving solutions to the market. However, a startling lack of diversity in the people on these trials potentially puts lives at risk and can lead to poorer outcomes for diverse patients.
According to Tufts Center for the Study of Drug Development (CSDD), the representation of Black people in trials for FDA-approved drugs during the period 2007–2017 was 65 percent below census levels and disease population. This powerful statistic demonstrates the dangerous underrepresentation of minorities in clinical trials.
Safe and effective treatments for all are only possible if there is patient diversity in the clinical trials of those treatments. As a leading provider of rich clinical evidence for our customers, we believe it is our responsibility to drive forward diversity in clinical trials. In a recent MedCity News article, I outlined three key actions I believe will achieve more diverse patient populations in clinical trials: increase education and restore patient trust, improve access to trials, and drive diversity in the clinical trial workforce. Here, I dive deeper into each of these areas.
Increasing Education and Restoring Patient Trust
The lack of patient diversity in clinical trials is a dangerous problem, but we rarely use this type of language to communicate the extent of the problem. Given the current lack of diversity in trials, a loved one could begin taking medication for a life-threatening condition without knowing whether it will truly be effective, because it was not tested on enough people like them. This is a dangerous proposition, yet it is the reality for many, and we need to discuss these potential consequences. We must change the way we talk about participating in clinical trials and talk about the importance of diversity and inclusion in trials and studies through impactful messaging that invokes emotion, empathy and action.
The lack of education about the value of clinical trials is also a significant contributor to the lack of trial participation within the Black community. As I shared in the recent MedCity News article, to reach a more diverse patient population, we must restore trust, broken by historical events like the Tuskegee Syphilis study and wrestling with cancer treatment advancements due to the cells of Henrietta Lacks being collected and used without her consent, to strengthen familiarity among diverse patient communities and the general public. This is an area Clario employees are working on already. Our employee resource groups (ERGs) are developing an inclusive toolkit for clinical sites to help them when speaking with minority patients about clinical trials. We are also working with CISCRP, an organization that advertises in print and digital publications that target geographies with high minority populations, to promote participation and raise public awareness about the importance of patient diversity in clinical trials.
Improving Access to Clinical Trials
We can work to improve health equity by increasing access to trials through remote, hybrid and decentralized clinical trial (DCT) models that bring trials to areas with diverse populations, rather than asking them to come to trial sites (an option often unavailable or that creates a major inconvenience to many in diverse communities). According to another Tufts CSDD study, access to studies (e.g., transportation issues and lack of minority clinical investigators) contributed to a lack of participation in non-white communities.2 Similarly, the remote model offers participants the opportunity to take part in trials from the comfort of their own home while mitigating bias experienced at on-site trials.
Given the various benefits of DCTs, we must encourage and enable clinical trial sponsors and contract research organizations (CROs) to take their trials into diverse communities. This is why Clario is focusing on our decentralized trials technology portfolio and scientific expertise, to enable sponsors to collect high-quality endpoint data from any modality or location while improving the patient experience.
Driving Clinical Trial Workforce Diversity
It is well-known that a person is more willing to participate in a clinical trial if someone who looks like them informs them of the opportunity.
Clario is working with industry organizations that play a vital role in solving the lack of patient diversity in clinical trials. For example, the Association of Clinical Research Organizations (ACRO) is committed to building a clinical research ecosystem that represents the world we live in, and the Association of Clinical Research Professionals (ACRP) focuses on growing the diversity of the clinical trial workforce and developing the existing workforce. We have a seat on the diversity advisory committee of both industry organizations and are working hard with them to identify the steps needed to solve these problems.
We are also working to do our part to improve the diversity of the clinical trial workforce. We are launching an internship program in partnership with Wake Forest University to bring more women and minorities into the clinical trial workforce. This internship program is only one example of an ongoing solution to a dangerous problem. We need more organizations and universities to join together and foster relationships to bring new generations into clinical research, supporting diversity and inclusion in the industry workforce to bolster trust and participation.
In closing, we need to ensure clinical trials are accessible to all. The whole industry must intensify its efforts by offering more inclusive educational materials, bringing trials into Black and other minority communities, increasing representation in the workforce, restoring trust and saving lives. These actions will ultimately improve the quality of life for all, and not just those who have traditionally been able to access or trust clinical trials.