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July 11, 2022, 7:58 a.m. EDT

FDA and drug makers deepen their commitment to clinical-trial diversity. Will it work?

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By Jaimy Lee

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In a similar vein, clinical research has long preferred the “male norm,” aka young and middle-aged healthy white men, according to the same National Academies report. That preference, which extends far beyond the clinic and into everyday medicine, comes at the exclusion of women and people of color. 

“Some physicians may think Black patients don’t know what clinical trials are, or can’t understand them, or won’t complete a clinical trial, or can’t understand the elements of one,” Walker said. “These little preconceived notions that you have that are monumental … keep us from even participating in a clinical trial.”

These biases set off a chain reaction that highlights how the design of clinical trials can be more prohibitive than Black mistrust of medicine: If physicians don’t tell Black patients about medical studies, they can’t decide whether to enroll in them. If regulators don’t require pharmaceutical companies to diversify their trials, they may choose not to. And if drug makers only partner with the same academic medical centers in the same cities to conduct medical research, that eliminates patients who are cared for in community health centers or live in rural communities.

“Our research establishment is too much concentrated in major medical centers,” Dr. Janet Woodcock, the then-acting commissioner of the Food and Drug Administration, said in January . “We had people dying in community hospitals everywhere, and yet they did not have access to clinical trials. And we couldn’t enroll them in order to learn faster about what worked for COVID and what didn’t work. And, even in the vaccine trials, specific efforts had to be made to have real representation of America in those trials. So I think what we learned is we have a long way to go.”

What we learned in 2020

Back in 2020, the FDA “strongly” encouraged the COVID-19 vaccine makers to design clinical trials that reflected the U.S. populations most affected by the virus. 

In the race to have the first FDA-authorized COVID-19 shot, Moderna /zigman2/quotes/205619834/composite MRNA +0.15% and Pfizer /zigman2/quotes/202877789/composite PFE -0.91% began sharing the demographics of participants enrolled in the Phase 3 clinical trials for the COVID-19 vaccines on their websites at a time when many Americans were closely watching the clinical trials, learning how medical research worked, and paying attention to differences in efficacy rates. About 10% of the participants in Moderna’s Phase 3 clinical trial in 2020 were Black, while 9.3% of the participants in the BioNTech and Pfizer study identified as Black or African American.

By the first half of 2021, most Americans knew getting vaccinated was safer than getting COVID-19, and that the shots were safe and effective, according to the Annenberg Science Knowledge survey.

“People paid attention to the science for the first time,” said Mary Stutts, a longtime pharmaceutical executive and the chief inclusion officer at Real Chemistry, a healthcare communications and innovation firm. “You had people talking about the difference between the J&J vaccine vs. Pfizer vs. Moderna. Talking to their primary-care doctors. Asking the questions about the difference.”

(Pfizer, for the record, still tracks enrollment demographics in its medical studies. “It’s embedded into the way that we work,” said Judy Sewards, the company’s head of clinical trial experience.)

That level of public awareness combined with corporate interest is fueling much of the activity we’re seeing today. Meharry’s Hildreth said more drug makers are contacting the medical college about clinical trials than they have in the past, shaking up a tradition in which some companies made lackluster attempts to enroll and retain people of color in pharmaceutical research. 

What’s happening now, Hildreth noted, is much more intentional than what has happened in the past. “I’m happy to see that some companies have been very aggressive in trying to leverage the moment that we’re in,” he said. 

Pfizer last year shared a decade’s worth of data on clinical-trial diversity for the first time in its history (and perhaps the first time in the industry), finding that the percentage of Black patients and women who participated in Pfizer’s clinical trials between 2011 and 2020 was equal to U.S. Census population levels. However, the company also discovered that there was “marked underrepresentation” of Black and Latino populations in cancer trials, which made up about 35% of the studies included in the retrospective analysis .  

Novartis /zigman2/quotes/203243705/composite NVS -0.73% in 2021 gave about $13 million to the Morehouse School of Medicine, a historically Black medical school, to establish a clinical trial center of excellence. (It just announced plans to invest an additional $17 million in similar centers at three more historically Black medical schools.) Roche Holding’s /zigman2/quotes/206324342/delayed CH:ROG +1.00% Genentech set up a network of cancer trial sites in historically Latino and Black cities like San Antonio and Birmingham, Ala., while the Bristol Myers Squibb /zigman2/quotes/202559280/composite BMY -0.86% Foundation is now providing clinical-research training to 250 medical students and physicians of color in varying areas of medical expertise. 

“What we’re trying to do is assure that our clinical trials reflect a population that mirrors the real world and is aligned with epidemiology of the disease,” Lorena Kuri, Bristol’s director of clinical-trial diversity strategy. “We need to think about that from the very beginning of the design of our trials.” 

While all of these programs are impressive in scope and detail, the recent involvement of regulators is what may put heat on companies and how they approach representation in clinical trials. 

The Centers for Medicare and Medicaid Services, which decides whether Medicare will pay for therapies or procedures, this year told the makers of the Alzheimer’s disease treatment Aduhelm and similar monoclonal antibodies in development that clinical-trial participants need to be representative of Alzheimer’s patients in the U.S. This came after the FDA approved Biogen’s /zigman2/quotes/201531540/composite BIIB +1.03% Aduhelm using data from two clinical trials that enrolled 19 Black patients out of a total of 3,285 participants. That’s less than 1% of the total participants, though roughly 14% of seniors with Alzheimer’s in the U.S. are Black. (Biogen disagreed with the CMS’s decision, though it said it supports the agency’s efforts toward “better diversity in clinical trials.”)

The FDA is firming up some of its own policies. The regulator this spring put out draft rules recommending drug makers present plans to enroll people of color in research for new drugs before they begin the large, pivotal Phase 3 clinical trials used to inform FDA applications. It also recently chose not to approve at least two cancer therapies based on clinical trials conducted in China. The FDA told one of those companies — Hutchmed /zigman2/quotes/208391399/composite HCM +2.67% , a Chinese drug maker — that it needs to conduct a clinical trial in more than one region or country to get approval for its pancreatic tumor treatment in the U.S.

Walgreens Boots Alliance /zigman2/quotes/203410933/composite WBA -0.48% cited the FDA’s guidance when it announced the launch of a new business that will use its stores and clinics as clinical-trial sites, particularly in underserved or rural communities. A proposed joint venture between HCA Healthcare /zigman2/quotes/205934574/composite HCA -2.07% , a publicly traded hospital company, and healthcare distribution giant McKesson /zigman2/quotes/206975466/composite MCK -0.62% announced in June aims to enroll people in “underserved communities” in cancer trials.

Corporations and regulators appear to be speaking the same language, and that’s happening at a time in which the pandemic forced the stagnant U.S. healthcare system to adopt telehealth and move as much care as possible out of hospitals.  

No longer do potential clinical-trial participants have to live within miles of a major academic medical center. They can use telehealth for some follow-up visits and get lab work or imaging scans close to home and have those results shared remotely with the trial team. Plus, millions more people now understand how clinical trials work and why it’s important to participate in them, and companies have paid close attention to that engagement.

“We have a long way to go,” said Walker, the patient advocate for the Metastatic Breast Cancer Alliance. “COVID, on the other hand, has taught us a lot that we can utilize with clinical trials.”

An earlier version of this story incorrectly described the Bristol Myers Squibb effort. It is a program of the Bristol Myers Squibb Foundation.

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