The Fed must correct the exclusion of people with disabilities from clinical trials

People with disabilities are largely excluded from clinical trials that could benefit them because federal agencies have failed to update rules governing how trials are conducted or failed to enforce existing laws that protect disabled Americans protect against discrimination, according to a new report.

The National Council on Disability, an independent federal agency, released the report this week detailing how various federal agencies implicitly and explicitly exclude people with disabilities from clinical trials. The report names several agencies, including the Food and Drug Administration, the National Institutes of Health, Health and Human Services and the Department of Justice.

While healthcare providers’ biases exacerbate this problem, the council’s investigation highlights how the federal apparatus encourages this exclusion. However, this is not the first time that disabled Americans’ participation in clinical trials has been identified as a problem. An unaffiliated 2022 study of 97 clinical research protocols was found surprising levels of exclusion for different disability groups – for example, the eligibility criteria excluded 68% of people with psychiatric disabilities and 53% of people with HIV or hepatitis.

Just as people with disabilities have done fought for more political powerthe costs of such exclusion from clinical trials – i.e. the worse health outcomes for people with disabilities – have become more visible in recent years. In one of the clearest examples of this exclusion: 90% of people with Down syndrome develop Alzheimer’s disease during their lifetime. However, the population is routinely excluded from trials of Alzheimer’s disease treatments, even though Down syndrome advocates have been crucial to ensure better financing of treatments.

“How can this population benefit from these potentially life-changing treatments if they are excluded from the trials? And how can anyone know the efficacy and safety of these therapies in this population – and one of the most affected populations? Exclusion demands too high a price,” said council vice-chairwoman Emily Voorde in a press release.

The authors’ recommendations fall into four categories: codifying eligibility parameters, developing funding mechanisms that prioritize more inclusive studies, making research papers and trial participation more accessible, and strengthening oversight and enforcement of existing laws that ensure that study sponsors adhere to these guidelines.

The NIH recognized people with disabilities as one population with health disparities in 2023, but federal agencies still have a long way to go to solve this “alarming reality,” says Claudia Gordon, head of the council.

“To effectively address health disparities, HHS must prioritize this issue as a cohesive policy issue across the department,” Gordon said.

The council recommended that Congress require the FDA to report to clinical trial sponsors on their efforts to enroll people with disabilities and require 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 over health care facilities to ensure that programs and services are accessible. These rules prohibit entities, such as providers and health insurers that receive federal funding, and federal agencies from discriminating against Americans with disabilities.