Researchers, epidemiologists and pharmaceutical giants have spent the past couple of years looking for ways to more effectively prevent COVID infection and better treat those who do become infected. With the virus once again surging, that effort is front and center.
But there’s a critical flaw in the process — and as obvious as it is, it has evaded correction for decades. Put simply, clinical trials, even the largest and most well-funded ones, seldom come close to representing the diversity of the society meant to benefit from them.
One reason? There is no federal mandate ensuring that diversity be part of the mix.
A recent COVID trials meta-study published in the Journal of the American Medical Association makes the point clearly. After scouring the results of 122 trials with a total of more than 176,000 participants nationally, researchers found that women were underrepresented when it came to participating in prevention trials, while Black and Asian people weren’t recruited in sufficient numbers when testing vaccines and other treatments for the virus.
Further, “We were disappointed to find that demographic representation was not always reported in the trials, which in my view is clearly a problem that could be readily rectified,” researcher Joseph Unger told Capital & Main.
Unger, with the public health sciences division of the Fred Hutchinson Cancer Research Center at the University of Washington, a co-author of the JAMA article. The Hutchinson Center provided funding for the study, which collected data on COVID trials from October 2019 to February 2022.
The trials participation, taken in total, was all over the map demographically — and again, it can’t be known fully, since many of the pharmaceutical company-based trials either didn’t collect demographic data or kept only limited types of information.
For decades, medical clinical trials in the U.S. have skewed heavily white — at times more than 80% of those participating.
Women have made up 52.4% of COVID cases in the U.S. to date, but they accounted for only 44.6% of those in treatment/vaccine trials, the authors found. Their representation in prevention trials was statistically closer at 48.9%.
Black people were well represented in treatment trials, but vastly underrepresented in prevention trials. Asian Americans were underrepresented in prevention trials relative to their overall percentage of the U.S. population. And Latino or Hispanic participants were overrepresented across the board, most likely because so many of the COVID trials took place in California, Florida and Texas, all of which have large Latino or Hispanic populations.
The importance of accurate representation by sex, race and ethnicity is critical. The point of the COVID trials is to determine the efficacy of prevention or treatment therapies and products when applied to the general public, which includes subsets of people whose sex, race or ethnicity may play a significant role in why they become ill or how their bodies respond to the virus — or to certain treatments. If a particular group of people isn’t well represented in trials, it’s harder to maintain “confidence that trial findings apply generally to the patient population, including patients with diverse backgrounds,” Unger said.
There are possible explanations for many of the results. Women may be underrepresented in part because men in the U.S. have experienced more severe COVID outcomes on balance, including hospitalization rates that may lead to them receiving trial treatments on site in disproportionate measure.
Black and Asian American patients, meanwhile, were well represented in treatment trials largely because those were conducted at hospitals to which they’d already been admitted, Unger said. Prevention trials, on the other hand, require traveling to a specific testing site, often several times over, at considerable cost. The authors suggest that waiving copays and coinsurance, along with “providing support for indirect expenses such as transportation, child care and time off from work,” may lead to improved participation by some racial and ethnic groups.
While some lawmakers have pushed for a congressional-level requirement for more diversity in clinical trials, none has yet materialized.
Big Pharma is responsible for the majority of the trials conducted. It’s also the industry trying to create prevention and treatment products that can be sold for profit. But when it comes to reporting on the participation in studies of key demographic groups, the pharmaceuticals are held to no specific standard.
That’s not a new development. For decades, medical clinical trials in the U.S. have skewed heavily white — at times more than 80% of those participating. And while Congress passed legislation 30 years ago requiring the National Institutes of Health to include more women and people of color in its studies, the NIH represents only about 6% of all trials in the country.
The U.S. Food and Drug Administration is well aware of the dynamic, and the COVID epidemic brought home the point with renewed emphasis. In April, the FDA issued draft guidance that “sponsors of medical products” — in this case, Big Pharma — submit a Race and Ethnicity Diversity Plan to the agency in the early stages of a clinical development.
Of course, it’s a recommendation, not a mandate. And while some lawmakers have pushed for a congressional-level requirement for more diversity in trials, none has yet materialized.
“What I’m hearing from clinicians out there is that they would like to do some of this stuff, but they’re not encouraged to do it by the administrators they’re working with,” FDA Commissioner Robert Califf said earlier this month at the Milken Institute’s Future of Health Summit. “It’s going to take progress in the health system if we’re going to get to where we need to be.”
That won’t happen without a strong push, and it may well take a federal law to drive the medical industry toward more diverse trials — a process that will require effort and expense. “Patients of all backgrounds should be able to enroll in trials in an equitable fashion to receive their care,” Unger said. Decades after the problem was identified, a solution remains well out in the distance.
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