The issue of representation has been spotlighted in politics, sports, and entertainment. Now the age-old problem of ensuring diversity confronts the pharmaceutical industry amid the COVID-19 pandemic.
As pharma tackles the huge pandemic problem, it has been forced to keep its clinical trials virtual. As a result, R&D departments have been grappling with a crucial problem: diversity.
How companies are doing clinical trials
The Food and Drug Administration (FDA) revealed recently that only 8% of participants in clinical trials undertaken to support approval of medicines were African American or Black. From this pool of participants, just 11% were Hispanic, and 6% were Asian. Moreover, not more than a third of them were above 65 years old. These figures were culled from the 2020 data on FDA’s Drug Trials Snapshots, which documented demographics from clinical trials involved in the approval of 53 medicines.
Representation is something that pharmaceutical companies have struggled to ensure. The industry is fully aware that drugs work differently among individuals based on ethnicity. There is a preponderance of evidence suggesting that communities of color are disproportionately underserved and affected by diseases, including the coronavirus.
Whether big or small, pharmaceutical companies are employing digital technology to conduct R&D. Telemedicine, decentralized clinical trials, and home health visits facilitate research needed to address the pandemic. However, even these efforts are admitted by pharma as insufficient to address the issue of diversity.
R&D heads struggle to make the participation of minority patients in clinical trials easier.
Craig Tendler, M.D., VP of clinical development for Janssen and executive of Johnson & Johnson, said that ensuring diversity goes beyond “allowing them to get their protocol evaluations locally.” While admitting that it is part of the solution, pharma needs to “do a lot more.”
How to solve the diversity problem
Experts are striving to address the issue of diversity in clinical trials. Greg Rots of consultancy firm PwC summarizes the primary points in diversity as awareness, access, and trust.
Rotz states that implementing decentralized trials is a significant first step, yet it does not address clinical trials’ equity, inclusion, and diversity concerns squarely.
To fully address diversity, pharmaceutical companies must acknowledge the race question in research. Patrice Matchada, head of the Novartis US foundation and its corporate social responsibility arm, says that if Black communities hesitate to participate in clinical trials, there’s a historical justification.
The shadow of the Tuskeegee clinical trials to study syphilis (1932-1972), the utilization of steam cells belonging to Henrietta Lacks without permission, and “father of gynecology” J. Marion Sims’ use of Black women as test subjects in clinical trials sans anesthesia.
In a period where the COVID-19 pandemic is raging, health experts state that the healthcare system’s response to communities and people of color is a failure. Based on data from the Centers for Disease Control and Prevention, most COVID fatalities among the younger population are disproportionately skewed against racial and ethnic minority groups. Moreover, these deaths are facilitated by deeply entrenched health and social inequities.
Therefore, diversity should be an urgent concern for the pharmaceutical industry.