Clinical trials to test the safety and efficacy of new drugs have a well-known diversity problem. For decades, drug trials have leaned heavily on white male participants, leaving much unknown about how the drugs would work across a wider population. The demographics of clinical trials have changed in recent years—today, according to a 2021 study in journal Digital Health, clinical trial participants tend to be older, female, non-Hispanic White, and highly educated—leaving broad swaths of the public out.
Black Americans, for example—who account for some 13% of the general population and some 22% of annual cancer cases—are consistently underrepresented in trials of novel cancer therapeutics. One 2020 study found that in clinical trials for multiple myeloma, a type of bone marrow cancer, Black Americans make up 20% of yearly cases, but median enrollment of Black Americans in trials has been just 4.5%.
To be sure, many drug makers have been trying, with at least some degree of success, to address these problems themselves. But new requirements in the Food and Drug Omnibus Reform Act (FDORA), enacted December 29, 2022, now make it mandatory, by requiring the sponsors of any phase 3 clinical trial—or other pivotal studies of a drug or medical device—to submit a “diversity action plan.” The detailed guidance is still being finalized, but it essentially means that the demographics of trial participants will need to better reflect the real-world prevalence of the diseases being studied.
That’s easier said than done. Finding enough research volunteers is already a challenge—more than 80% of clinical trials fail to enroll enough patients in time. There are many complicated reasons behind the lack of trial diversity, including institutional distrust, financial and logistical barriers, and lack of access to information about trials. Startups including Power, Acclinate, and Trial Library are focused on improving access on the patient side.
But another big factor is the lack of diversity in the type of sites that host clinical trials. “One of the main reasons so many patients are left out of clinical research is because most of the trials are done at the very large academic hospitals,” says Kourosh Davarpanah, CEO and cofounder of Inato, a “marketplace platform” that connects clinical-trial sponsors with trial sites and today announced $20 million in Series A2 funding from Cathay Innovation, Obvious Ventures, and others. “That means about 70% of trials are done in those 5% of sites. What is less known is you actually have tens of thousands of smaller hospitals that have clinical research expertise, but really struggle to get access to the right trials.”
The company, which is headquartered in Paris and operates in Europe and the United States, is essentially a matchmaking service. “We’re not about rebuilding the entire system,” says Davarpanah. “Pharma companies and contract research organizations are really good at partnering with a small number of large sites. They can continue doing that. We’re helping them connect with the long tail of tens of thousands of community sites.” (Paradigm, another startup focused on connecting trial sponsors and community clinics, raised a $203 million Series A in January, one of the largest healthcare funding rounds of 2023 so far.)
Inato works with about 2,500 sites globally, located in urban centers as well as more rural settings. “We’re really looking at secondary, tertiary hospitals outside of major city centers,” says Davarpanah. “The drug companies have the coast of the U.S. very well covered, but everything in between is an opportunity.” These local sites generally already have some experience running trials, and—key to diversity efforts— often have unique relationships and access in the community that help boost representation for specific trials.
Recently, for example, Inato worked with a site in South Dakota that recruited large numbers of Native American participants—who are historically underrepresented in drug trials—for a study of a new vaccine. Apart from demographics, community sites can often devote more attention to any given trial. “A [large] academic site might have 10 times more patients than the smaller community site, but will typically have 30, 40, 50 times more trials,” says Davarpanah. “Our sites are really going to focus all their efforts on one trial for one given sub-segment of their patient population.”
This brings benefits for patients—allowing people with cancer to gain access to cutting-edge treatments at an earlier stage of the disease, for example. And the platform, which is free for trial sites (trial sponsors pay fees), helps smaller institutions attract the steady flow of trials they need to maintain the staffing to conduct research that benefits patients.
Inato chief strategy officer and cofounder Liz Beatty says the company currently works with a third of the top 30 clinical-trial sponsors—including pharmaceutical companies Sanofi and Moderna—supporting studies in oncology, immunology, neurology, and vaccines. “Typically, any treatment that you can get in the community is a good fit for us,” says Davarpanah.
With its recent funding, the company will ramp up its technology and global teams in the U.S. as well as in Europe. There, says Davarpanah, clinical-trial diversity is also a priority, although “it’s definitely not defined in the same way. Whereas diversity is heavily focused, at least today on ethnicity and more and more gender in the US, it’s much more socioeconomic diversity in France, or Europe.”
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