FAIR TRIAL: Excluding people with IDD from clinical trials means the treatments used for a variety of conditions have not been evaluated to determine the benefits or the risks of use in people with specific developmental conditions.
HOPE IS ON THE HORIZON
In September of 2023, the National Institutes of Health (NIH) formally designated people with disabilities as a population with health disparities, allowing greater opportunities to include people with disabilities in research efforts. "Research to understand the barriers and unmet needs faced by people with disabilities, and to develop effective interventions to address them, is needed. This designation will help to improve access to healthcare and health outcomes for all people." 4
In addition, the US Food and Drug Administration (FDA), the entity responsible for approving drugs and medical devices, recently sought public input into a proposal to address inequities in study design, by requiring those who are conducting clinical trials to use disease prevalence and incidence data by demographic group, to inform clinical trial enrollment by those who are expected to use a particular drug or device. This means information about disability status must be considered in the study design, to ensure that people with disabilities are not unnecessarily excluded.
As advocates for people with IDD, we play a critical role in supporting full and meaningful participation in all activities, including clinical research trials. Understanding the history of exclusion and the efforts to promote inclusive study design and implementation will help ensure that people with IDD have the same opportunities as others to participate in research activities. •
References
- Public Workshop to Enhance Clinical Study Diversity. 2023. US Food and Drug Administration & Clinical Trials Transformation Initiative. ctti-clinicaltrials.org/wp- content/uploads/2023/12/FDORA-Diversity-Primary-Slide-Deck-11.28.-23-FINAL.pdf
- Inclusive Methods for Engaging People with Intellectual and Developmental Disabilities in Research Practices. 2023. American Institutes for Research® (AIR®) Center on Knowledge Translation for Disability and Rehabilitation Research. ktdrr.org/products/info-briefs/KTDRR- EngagingPeopleWithIDD-508.pdf
- Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification. 2022. Health Affairs. healthaffairs.org/doi/10.1377/hlthaff.2022.00520
- NIH designates people with disabilities as a population with health disparities. 2023. National Institutes of Health (NIH). nih.gov/news-events/news-releases/nih-designates-people- disabilities-population-health-disparities
ABOUT THE AUTHOR:
Lorene Reagan, RN, MS, has over 35 years of experience in the field of intellectual and developmental disabilities (IDD). Lorene is the former Bureau Chief for IDD services in New Hampshire, was Manager of Care Management for a Medicaid managed care organization, and a Principal in a consulting firm focusing on state Medicaid policy and operations. She is the former Director of Public Relations at IntellectAbility (replacingrisk.com) which provides tools and training to agencies, governmental entities, and supporters of people with intellectual and developmental disabilities to foster early recognition and mitigation of health risks and promote health equity for people with IDD. Currently, Lorene provides strategic consulting services focusing on health risk management and health equity for people with IDD.