Advocates call for more diverse clinical trials

As the biopharma sector looks to modernize clinical trials, some industry experts are calling for those efforts to extend beyond new AI-enabled software and technologies by including more diverse participants.

Del Smith, co-founder and CEO of health diversity tech company Acclinate, told attendees at a November biopharma conference in Boston that health equity should be at the center of any clinical trial. But, he stressed, companies can’t just tout health equity; they must actually take steps to achieve it.

That means including patients from minority groups, LGBTQ+ populations, and those with obesity, he said. Researchers must also take the time to learn about their participants and make inroads to those communities.

“We’ve seen, playing out in this space, the importance of having […] diverse people involved in this process,” Smith said. “It’s not that simple because we also know that just looking like someone doesn’t necessarily mean you have the same lived experiences.”

For decades, women and people from various racial and ethnic groups have been either excluded from or underrepresented in clinical research, making it hard to predict how certain medications or therapies could affect those populations. Congress passed legislation in the ’90s to ensure more women and minorities were included in such research, but representation issues persist.

Women, for example, accounted for as little as 25% of participants in some clinical drug trials for diseases affecting men and women in 2022, according to the FDA’s Drug Trials Snapshots Summary Report. The majority of patients enrolled in pivotal trials for 37 novel therapies were white, followed by Asian and Black participants.

Meanwhile, many researchers have only recently started asking about a participant’s sexual orientation and gender identity, according to the National Institutes of Health.

The 1932 incident in Tuskegee, where the federal government failed to inform Black participants of the involved risks in a syphilis study, exacerbated tensions between medical professionals and underinvested groups, and created mistrust of clinical research.

Beyond racial and ethnic groups

Advocates for patients with obesity have also called for greater representation in biopharma research, arguing that their lack of inclusion has made it hard to gauge how certain drugs may affect people with higher body mass indexes.

Groups—including the American Society for Metabolic and Bariatric Surgery, the Obesity Action Coalition, the Obesity Medicine Association (OMA), the STOP Obesity Alliance, and the Obesity Society—recently urged the FDA and pharma companies to include people with obesity in clinical trials before new drugs are approved.

“We must ensure drugs are safe and effective and labeled correctly for everyone for whom they are intended,” OMA President Angela Fitch said in a joint statement last month. “Drug companies don’t get a pass on people with obesity.”

The advocates asked drugmakers marketing medications with standard doses that have safety and effectiveness issues for people with obesity to “update their labeling immediately.”

The groups specifically want to see updated drug labels for Rexulti (brexpiprazole)—a medication approved to treat schizophrenia and depression—and Noxafil (posaconazole)—a medication approved to prevent fungal infections.