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Make Sure People with Disabilities Are Included in Clinical Trials: Your Participation Is Needed!

November 15, 2023
Vicki Gottlich, Deputy Administrator for Policy and Evaluation

The U.S. Food and Drug Administration (FDA) is holding a two-day virtual public workshop to promote diversity in clinical trials on November 29 and 30. Of special interest during the workshop:

  • November 29, 2023, 1:25-1:55 PM ET
    • Session 3B: Approaches to Support the Inclusion and Clinical Study Participation of Individuals with Disabilities Including Intellectual or Developmental Disabilities 
  • November 30, 2023, 10:05-10:35 AM ET
    • Session 3C: Approaches to Support the Inclusion and Clinical Study Participation of Individuals with Mental Illness

You can view the full agenda for the two-day workshop and register for the event via Zoom. You can also submit comments for 60 days afterwards (until January 29, 2024). 

Keep reading for more information on the importance of including people with disabilities in clinical trials and how you can get involved.

People with Disabilities Have Historically Been Excluded from Clinical Trials at High Rates

Clinical trials evaluate the safety and efficacy of medical interventions like drugs, vaccines, and devices. To understand how the results of clinical trials will translate into the real world, a trial must have a diverse pool of research participants. Despite this being the case, people from underserved communities — such as people of color, LGBTQ+ individuals, older adults, and people with disabilities — have historically been underrepresented in clinical trials.

One in four people have disabilities, yet disabled people are frequently excluded from clinical trials. Recent research shows that nearly 75% of clinical trials either directly or indirectly excluded people with intellectual and developmental disabilities (I/DD). For example, few trials for Alzheimer’s disease have included people with Down syndrome, even though they are disproportionately affected by Alzheimer’s and dementia. Furthermore, people with I/DD want to participate in clinical trials and have strong confidence in their own ability to do so. Similarly, a recent study found that 68% of clinical trials evaluated excluded people based on psychiatric conditions, often without clear justification.

While the exclusion of people with disabilities may sometimes be appropriate given the nature of the research being conducted, too often it is based on stereotypes or biases against specific disabilities or a failure to take into account the availability of accommodations that can facilitate participation.

The Exclusion of People with Disabilities from Clinical Trials Weakens Their Usefulness and Can Violate Federal Civil Rights Laws 

The exclusion of disabled people from a clinical trial may impair its usefulness by excluding subpopulations most in need of the intervention being tested. Limiting the participation of people with disabilities in clinical trials also deprives them of benefits that may be offered through the trial, such as cutting-edge diagnostic or medical care that is unavailable elsewhere.

Importantly, exclusionary policies may be illegal. Civil rights laws, including the Americans with Disabilities Act, Section 504 of the Rehabilitation Act of 1973, and Section 1557 of the Affordable Care Act, prohibit discrimination on the basis of disability and require the sponsors of clinical trials to provide reasonable modifications to allow participation. The recently updated proposed regulations to Section 504 of the Rehabilitation Act specifically address the discriminatory exclusion of people with disabilities in clinical trials.

There are a number of steps trial sponsors can take to ensure communication and physical accessibility. Additionally, disabled people may also rely on supported decision making and other accommodations to facilitate their participation in clinical trials.

Federal Efforts are Underway to Improve Access to Clinical Trials for People with Disabilities

The Food and Drug Omnibus Reform Act (FDORA), signed into law by President Biden on December 29, 2022, includes several provisions directly aimed at increasing diversity in clinical trials. Section 3603 requires public workshops to gather input from a variety of stakeholders, including patients and disability advocates. According to the law, these workshops must solicit feedback on approaches to support the participation of underrepresented groups and people, considerations regarding informed consent, and inclusion and exclusion criteria for people with I/DD.

The information gathered during the November 29 and 30 workshop, in addition to comments submitted by the public, will form the basis for a report that the FDA will submit to Congress. It is critical that you participate in these sessions and submit public comments!   

Last modified on 11/15/2023

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