Between the 2010 and 2020 U.S. Census, the percentage of Americans self-reporting as White declined from 71% to 61.6% of the total population. And yet the FDA reports that of the 32,000 participants in 2020 clinical trials that resulted in the approval of 53 novel drugs, 75% were White. This disconnect, along with others, results in the distribution of pharmaceuticals and other medical compounds and products to diverse communities without a complete picture of their potential side effects or relative effectiveness.
The price tag for this marginalization is both human and financial. A staggering $1-2 trillion in economic losses is tied to the persistent and pervading health care, scientific and medical inequities impacting underrepresented demographics. Many of these losses are rooted in a lack of diversity in researching and developing life-saving drugs and medical devices through clinical trials. With less than 8% of Blacks/African Americans and fewer than 5% of Latinx patients participating in clinical trials, much work lies ahead to make clinical trials more equitable and inclusive.
A recent webinar hosted by RGP Healthcare’s VP and Global Head of Life Sciences R&D, Marcia Brown-Rayford and LaShell Robinson, Director of Diversity & Inclusion in Clinical Trials at Takeda Pharmaceutical, explored these trends and “Strategic Approaches to Achieving Diversity, Equity, and Inclusion in Clinical Trials.”
Building Trust Starts with a Look in the Rearview Mirror
Recent high-profile drug recalls related to adverse events, and side effects in diverse populations have shed light on the issues, causing the FDA to issue guidance that clinical trials should proactively seek to enroll patients that reflect the people who will use the medications.
Pharmacogenetic research has uncovered significant differences among racial and ethnic groups in metabolism, effectiveness, and side-effect profiles of clinically important drugs and unearthed disparities in the prevalence of disease and mortality rates by gender, race, and ethnicity. However, organizations have struggled to bridge the divide, in part because of a loss of trust over decades of arguably unethical clinical studies, often performed on unsuspecting minority communities without informed consent.
The Tuskegee Study impacted my father’s perception of health care. My participation in clinical research as an employee on the healthcare side has helped rebuild that trust, but not everybody has that advantage.LaShell Robinson, Director of Diversity & Inclusion in Clinical Trials at Takeda Pharmaceutical
African-, Asian-, Latin- and Native-Americans have borne the double burden of being underrepresented in clinical trials for lifesaving drugs and devices and also as unwitting participants in studies ranging from sexually transmitted diseases to inbreeding—as recently as 1994. Rebuilding trust will be a long journey, but education and access to and inclusion within ethically conducted diverse clinical trials with transparent privacy and safety guardrails are clear first steps.
Decentralized Clinical Trials Can Be Effective in Advancing the DE&I Journey
It’s important to note that diversity goes beyond race, color, and ethnicity to include factors like nationality, socioeconomic status, education, marital status, language, age, gender, mental or physical ability, and more. When considering trial protocols, understanding those nuances and the disease burden within populations is essential to equitable design. Trials must be structured to provide access and remove barriers to participation for all people impacted by a disease.
The COVID-19 pandemic has opened new pathways to close gaps and enhance the participation of marginalized patient populations—enabled by remote clinical trials and supported with digital technologies and platforms, including wearables. This forced shift has resulted in increased representative demographics within trials, making them more accessible to populations outside of metro areas while helping to remove logistical challenges. For example, healthcare providers extending normal business hours to accommodate after-work patient visits is an approach to address access issues.
Decentralized clinical trials can be a key tool to advancing diversity, equity, and inclusion (DE&I). Additionally, organizations must make a concerted effort to educate underrepresented populations on the importance and availability of drug trials (and their connection to medications), eliminate barriers like linguistic challenges, and build trust at the local level by engaging communities (i.e., physicians, patient advocacy groups, etc.) in trial or protocol design.
Representative Inclusiveness in Research Studies is Imperative to Patients and Your Business
In addition to the criticality of real-world patient population representation in clinical trials for commercial availability of safe and effective drugs and medical devices, there are also financial incentives for organizations to elevate DE&I in clinical protocols. Streamlining the number of trials, reducing drug development timelines, obviating the costs of regulatory submissions and approvals, mitigating drug recalls, and avoiding lost market entry opportunities are among them. Not only is the need for DE&I in clinical trials clear, but so is the financial value proposition to a company’s bottom line from a top-line revenue, cost reduction, and profitability perspective. Locked within the core of diversity, equity, and inclusion in clinical trials is untapped growth opportunities scientifically, operationally, and economically.
To learn more about how your organization can improve DE&I in clinical trials, watch an on-demand recording of our webinar, “Strategic Approaches to Achieving Diversity, Equity, and Inclusion in Clinical Trials.”