The data are clear: White patients are taking up the majority of clinical trials.
About 130 million Americans across various races are "being somewhat ignored, [or] deprioritized, in clinical trials" that support regulatory approval, said Yele Aluko, M.D., chief medical officer for EY Americas, in a November Fierce Biotech interview. That's "embarrassing," Aluko added.
We also know for sure that drug developers and their partners need to include more races and women in studies of their medicines because side effects and treatment effectiveness aren't universal.
But the drug development industry—despite a lot of progress and an awareness among the largest pharmas out there—still gives short shrift to many underrepresented populations in clinical testing. This is especially true for studies used to prove treatment efficacy to gain regulatory approvals from the FDA and others.
There's momentum on this front going into 2022, but the industry still has much to accomplish. Multiple biopharmas and decentralized trial providers are making commitments to diversify their clinical studies through multiyear efforts.
This includes Novartis setting aside $13.7 million for three research centers at the Morehouse School of Medicine for clinical trials and Abbott's five-year, $5 million efforts at historically Black colleges and universities.
Eli Lilly self-identified a problem with diversity in its oncology trials, where Black people represent just 11.5% of patient populations compared to 39% across its broader portfolio of studies. The company is working to address a lack of trust in medical institutions, reduce barriers to inclusion and establish community partnerships in an effort to boost minority enrollment in clinical trials.
The FDA is no longer looking the other way when trials come to them without a diverse population. Just this summer, the regulator rejected Incyte's PD-1 drug for anal cancer after the agency's advisers cited lack of diversity as one reason for its vote of no confidence in the med.
And the first year of the pandemic was no better, as Fierce Biotech chronicled in its 2021 forecast.
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In some areas like stroke treatment trials, the needle has barely moved over three decades for representation of women. That's 30 years of almost no improvement, according to a study published in Neurology, the medical journal from the American Academy of Neurology. In breast cancer, the numbers are striking: For the four new treatments approved in 2020 by the FDA, trial patient makeup was 2% to 9% Black Americans and 0% to 9% Hispanics or Latin Americans.
A bevy of virtual trial providers are raising megarounds, like Medable's $304 million series D in October, and others are more nascent, like Lightship and Slope. They all want to decentralize access to investigational treatment studies, and they say time and again that this is the route to making trials more inclusive of traditionally underrepresented groups.
These companies are trying to squash the disparities glaringly present among in-person clinical trial sites, which typically are staffed by white investigators. In academic and community hospital settings in the U.S., white personnel comprise a whopping 68% of staff. The number is lower in private practices at 56% white.
To improve numbers, disease-specific organizations are calling for more patient participation. Other groups, like the Alzheimer's Association, are working on engaging with specific communities and organizations that help recruit specific populations.
Race and gender are among the two demographics getting the biggest spotlight for trial diversity. The LGBTQ+ community might also get a bigger megaphone in 2022 with more calls for including sexual orientation in clinical trials. Another initiative is to try to make clinical research more accessible to patients who identify as transgender and nonbinary.
Time will tell whether biopharmas willingly diversify their trials. As we enter yet another pandemic year, the omicron variant is likely to dominate the news, and so will COVID-19. Drug developers are still testing new treatments for SARS-CoV-2, but there are thousands of other investigational drugs being studied in humans across hundreds of indications. They all need to better represent the population.
Early in the pandemic, plenty of criticism was leveled at companies developing vaccines for not featuring diverse trial populations in their studies for the crucial COVID-19 vaccines. But there's good news: As companies pivoted to keep operations for their non-COVID studies going during the pandemic, they stocked up on tech that makes decentralized trials easier and other key tools that the industry has known for a long time can help bring in a broader range of people.
So the question for 2022 is this: Will they use those new tools?