Health Equity Requires Diversity in Clinical Trials
By Michelle McMurry-Heath and Rahul Dhanda
Covid-19 has laid bare America's health inequities.
More than one in 555 Black Americans have died from Covid-19, according to the latest data from APM Research Lab. Latino Americans are about twice as likely to die from the virus as whites.
Countless health and economic disparities contribute to this unequal toll. Fixing these inequalities will require systemic changes across our society.
One important place to get started is clinical trials, studies in which scientists test a new drug or medical device on people to evaluate whether it's effective. Ensuring that diverse groups are included in clinical trials leads to a better understanding of how a therapy will work. Without that knowledge, people of color end up at an even greater loss.
Lacking access to clinical trials can also have a direct impact on an individual's health. For patients with aggressive diseases like advanced-stage cancer, sometimes a trial drug offers the best shot at a longer life.
Communities of color have historically faced barriers to trial participation, with African Americans, who make up about 13% of the U.S. population, accounting for only 5% of enrollment in clinical trials. Latinos make up 18% of the population, but only 1% of participants.
Luckily, using lessons learned from the pandemic, drug and diagnostic companies are exploring ways to reach under-represented communities. Covid-19 vaccine makers Moderna, for instance, slowed down clinical trial enrollment to increase representation of minority groups. Pfizer increased its trial size to include more minorities.
Ultimately, Black and Latino enrollment in both trials came close to their share of the total U.S. population.
This bolstered confidence that the vaccines would work across all demographics. Being able to point to diverse representation helps reassure communities that may be skeptical about receiving the vaccine, which is essential to ending this pandemic.
While Covid-19 vaccine trials mark progress towards equity, there is more that companies, research institutions, and regulators can do.
More trial organizers could make participation logistically easier. Ideas include shipping drugs to patients' homes and gathering results through online reporting or wearable technology.
Documenting minority representation in clinical trials should also become standard practice. Between 2011 and 2020, most clinical trials reported the age and sex of all of their participants, but only 58% reported race, and just 34% reported ethnicity, according to a February JAMA study.
Federal agencies like the National Institutes of Health and the Food and Drug Administration could develop policies and processes that expand clinical trial sites and trialists, implement innovative clinical development tools and approaches to help companies meet diversity benchmarks and communicate meaningful demographic information to regulators, patients and physicians.
Finally, the biotech industry needs to diversify its own workforce. Last year, the Biotechnology Innovation Organization published its first-ever report on diversity in the industry, finding that only 16% of companies had women CEOs and just 11% had non-white CEOs.
Building a more diverse biotech workforce calls for educational investments to attract diverse students to science, technology, engineering, and math. At companies, it will require new hiring practices, mentoring programs to support diverse future leaders, and policies that reward woman- and minority-owned businesses in the supply chain.
We've come far, but we can -- and must -- do better. Last year will be remembered as one of the most challenging in our lifetimes. Let's make this one memorable for bringing true diversity to biomedical research.
Michelle McMurry-Heath, M.D., Ph.D. is the president and CEO of the Biotechnology Innovation Organization. Rahul Dhanda is the president and CEO of Sherlock Biosciences.
