Federal report illuminates need for disability inclusion in clinical trials

Federal report illuminates need for disability inclusion in clinical trials

For Immediate Release

Aug. 14, 2024

WASHINGTON-Today, the National Council on Disability (NCD) released a timely report on exclusionary practices that prevent people with disabilities from participating in clinical trials.

The Implicit and Explicit Exclusion of People with Disabilities in Clinical Trials discusses how healthcare practitioners' internal biases and federal policies contribute to the participation rates, and how the disparity affects people with disabilities and the efficacy of clinical trials.

Federal agencies have made efforts to address exclusionary practices pertaining to people with disabilities, including the U.S. Department of Health and Human Services' explicit requirements of clinical trials inclusion in the amended Section 504 regulations. However, much work remains to ensure that people with disabilities are meaningfully included in clinical trials.

"A significant step forward was made last September when the NIH finally recognized individuals with disabilities as a health disparities population," said NCD Chair Claudia Gordon.

"Building upon this progress, our report underscores the alarming reality that people with disabilities are systematically excluded from crucial clinical trials," said Gordon. "To effectively address health disparities, HHS must prioritize this issue as a connected policy matter across the entire department."

"The fact that 90 percent of people with Down syndrome will develop Alzheimer's during their lifetimes and yet none of them have ever been included in a clinical trial for Alzheimer's treatments is a poignant example of the cost of exclusion," said NCD Vice Chair Emily Voorde. "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."

This report offers recommendations for federal agencies, Congress, and healthcare practitioners focused on improving the participation rate of people with disabilities in clinical trials.

NCD's key findings include:

• Multiple efforts in recent years have been made to enhance diversity in clinical trials; however, disability is not included as a dimension of diversity in such efforts.

• The inclusion and exclusion criteria embedded in clinical trial criteria can create barriers for people with disabilities - often without scientific justification.

• Clinical trials for Alzheimer's therapeutics have excluded people with Down syndrome, even though 90 percent of people with Down syndrome will develop Alzheimer's by the age of 55.

NCD's key recommendations include:

• FDA and HHS should develop guidance on eligibility parameters for investigators, similar to FDA's "Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors."

• NCD recommends FDA should promulgate regulations that incorporate the "Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors," making the guidance legally enforceable.

• Clinical trial study teams should incorporate overt explanations and justifications of the availability of reasonable accommodations in informed consent documents.

Read this and all of NCD's reports at NCD.gov.

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