Long before I became a healthcare executive, I began my medical career on a different side of the stethoscope. As a practicing doctor in Madrid, I learned firsthand the value of treating all patients with empathy, dignity, and individualized care. Throughout my career, I’ve always focused on taking into account the full measure of a patient’s personal experience in order to provide answers that work for them. Because without this perspective, we are simply treating diseases, not people.
The same principle, of putting patients first, should go into the unprecedented global effort of developing a viable vaccine for the SARS-CoV-2 coronavirus. Yet this urgent search is running into one of the greatest challenges affecting modern pharmaceutical research: a potentially risky lack of diversity in clinical trials. In seeking solutions to a global crisis, we are struggling to take the full measure of humanity.
A 2020 report from the Tufts Center for the Study of Drug Development that evaluated the diversity of pivotal clinical trials on experimental medicines from 2007 to 2017 found that female, Black, and Latinx participants were chronically underrepresented, while male and Asian participants were frequently over-represented. And while trial participation among Hispanic/Latinx populations did increase over those ten years, which is a positive sign, the representation of Black participants did not. In addition, only 37% of the studies reported data on the ethnicity of their participants, which could invite questions about the broader effectiveness of the treatments being tested.
The reasons for this well-acknowledged yet persistent lack of diversity in clinical trials are complex. Some people are skeptical, or wary of taking part in medical studies. Clinicians fail to coordinate outreach efforts to build trusted relationships with a wide enough range of potential participants. Due to these challenges, clinical trials often rely on data from the most easily available participants. But these demographics do not always correlate to the realities of how a disease spreads, or affects different people. This can lead to the development of treatments that are ineffective for some, or even potentially detrimental for population groups who were not adequately tested.
COVID-19 has proven itself to be a truly global disease with the potential to affect everyone it touches. But it is becoming increasingly evident that the virus and its complications present a higher risk for certain demographics. Because of this, any viable vaccine must be tested for efficacy among those populations who face the highest risk. Globally, this tends to mean older and immunocompromised individuals. In the United States — which has experienced the most COVID-19 cases and deaths among all nations — it is Black and Hispanic populations who are more likely to become infected.
Unfortunately, these high-risk populations also tend to have limited access to effective healthcare options, and are therefore at an elevated risk of developing complications from COVID-19 which can lead to hospitalizations and deaths. Any vaccine trialled on a population that is not diverse, or those who are already in optimal health, may not help the people most in need of it. That makes diversifying these clinical studies an absolute necessity.
When our research team at Merck KGaA, Darmstadt, Germany began Phase 2 trials of an investigational drug named M5049 that may be crucial to mitigate complications from COVID-19 pneumonia, we thought hard about where to conduct our clinical trials. We increased our community outreach and recruiting efforts in regions with a large percentage of Black and Latinx populations, including Detroit, St. Louis, and south Texas, as well as in multi-ethnic locations in Brazil. Our early trials have already attracted a notably diverse group of participants, and we intend to build on this in future studies.
Fortunately, we are not alone in our efforts to increase diversity in clinical trials for COVID-19 treatments. Emerging trends suggest that companies with ongoing COVID-19 investigational therapy and vaccine trials are placing a heavy emphasis on diversity across study participants—even slowing the pace of trials in order to ensure they can more closely represent the demography of the disease’s impact across Black, Latinx or Hispanic, and Native American participants.
But the problem of homogeneity among clinical trial participants is not exclusive to COVID-19. In fact, it is an industry-wide issue, and as such it demands an industry-wide call to action.
As I help steer a global biopharmaceutical company present in over 150 countries, I am acutely aware of the need for increased diversity across clinical trials in every area of medical study — not just in trials for potential COVID-19 treatments like M5049, but across our entire global R&D pipeline. This is especially important in oncology, for example, as different types of cancer are more prevalent or more severe in some demographics than in others. Yet a 2017 study found that fewer than 1 in 20 U.S. cancer patients take part in clinical trials.
To change this trend, we must continue to evolve clinical trials on three key fronts. First, we must ensure that all treatments are being specifically tested for effectiveness among the populations that are most seriously affected by the disease. Secondly, we must ensure that treatments for diseases which afflict a diverse population are being tested among clinical trial participants whose diversity closely matches that of the populations being affected.
And thirdly, we must continue to invest in community education and outreach, especially within populations which have historically been underrepresented in clinical trials. Establishing trusted relationships might help accelerate the development of life-changing treatments that are as broadly or specifically effective as the problem requires.
To do otherwise will risk not just the creation of insufficient or potentially ineffective treatments, but will also foster additional skepticism toward medical science from those who are inclined to doubt such expertise. This distrust has already complicated the challenge of containing and eliminating the SARS-CoV-2 coronavirus; exacerbating it further would only make our global ability to combat future pandemics even more difficult.
This moment must serve as a wake-up call for all healthcare professionals to intentionally expand the diversity of their clinical trials as a rule going forward, rather than as the sudden new exception. Treatments that are only proven to work for certain people within a population can no longer be considered a full success in the fight against COVID-19 or any other disease. Instead, they are simply one step in the right direction.
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