People with disabilities are largely excluded from clinical trials that could benefit them because federal agencies have failed to update rules that govern how trials are conducted or neglected to enforce existing laws that protect disabled Americans against discrimination, a new report has found.
The National Council on Disability, an independent federal agency, released the report this week detailing how several federal agencies implicitly and explicitly exclude people with disabilities from clinical trials. The report singled out several agencies including the Food and Drug Administration, National Institutes of Health, Health and Human Services and Department of Justice.
While health practitioner biases worsen this problem, the council’s research highlights how the federal apparatus encourages this exclusion. This is, however, not the first time disabled Americans’ participation in clinical trials have been identified as a problem. A non-affiliated 2022 study of 97 clinical trial protocols found startling levels of exclusion for various disability groups — e.g., eligibility criteria removed 68% of people with psychiatric disabilities and 53% of people with HIV or hepatitis.
As disabled people have fought for more political power, the cost of such exclusion from clinical trials — i.e., the poorer health outcomes for people with disabilities — has become more visible in recent years. In one of the starkest examples of this exclusion, 90% of people with Down syndrome develop Alzheimer’s during their lifetimes. However, the population is routinely excluded from trials for Alzheimer’s treatments, even though self-advocates with Down syndrome have been pivotal for securing better funding for treatments.
“How can this population benefit from these potentially life-changing treatments if they’re excluded from the trials? And how can anyone know what these therapeutics’ efficacy and safety is on this population – and one of the populations most affected? Exclusion exacts too high a price,” said the council’s Vice Chair Emily Voorde in a press release.
The authors’ recommendations fall into four buckets: codifying eligibility parameters, developing funding mechanisms that prioritize more inclusive trials, making trial documents and trial participation more accessible and beefing up oversight and enforcement of existing laws that would ensure trial sponsors abide by these guidelines.
The NIH recognized people with disabilities as a population with health disparities in 2023, but federal agencies have a long way to go to fix this “alarming reality,” said Claudia Gordon, who heads the council.
“To effectively address health disparities, HHS must prioritize this issue as a connected policy matter across the entire department,” said Gordon.
The council recommended that Congress require the FDA to ask clinical trial sponsors to report their efforts to enroll people with disabilities, as well as demand that diversity action plans include ways to increase the participation of people with disabilities in clinical trials.
The report suggested that HHS and DOJ increase their oversight and enforcement of Section 504 of the Rehabilitation Act of 1973 and section 1557 of the Affordable Care Act at health care facilities to ensure that programs and services are accessible. Those rules prohibit entities, such as providers and health insurers that receive federal funding, and federal agencies from discriminating against Americans with disabilities.