ACL’s disability network, people with disabilities, and advocates have until January 29, 2024, to submit comments on the FDA Workshop to Enhance Clinical Study Diversity, which included a session focused on inclusion of people with disabilities (with a focus on people with intellectual and developmental disabilities). ACL previously shared a blog on the workshop and open comment period: Make Sure People with Disabilities Are Included in Clinical Trials: Your Participation Is Needed! The blog detailed the historic exclusion of people with disabilities, as well as people with psychiatric conditions, in clinical trials.
Comments on the FDA workshop are an important part of FDA’s efforts to solicit input from stakeholders. To view the workshop segment on inclusion of people with disabilities (session 3B) that features ACL’s Alison Barkoff, start at the 3:14:40 mark of the Day 1 video (slides for session 3B begin at slide number 112). The workshop also included a session (3C) titled, Approaches to Support the Inclusion and Clinical Study Participation of Individuals with Mental Illness (slides for session 3C begin on slide 128 and the session begins at the 00:03:45 mark of the Day 2 video).
The information gathered during the FDA workshop, in addition to comments submitted by the public, will form the basis for a report that the FDA will submit to Congress.
Comments on the FDA workshop are an important part of FDA’s efforts to solicit input from stakeholders. To view the workshop segment on inclusion of people with disabilities (session 3B) that features ACL’s Alison Barkoff, start at the 3:14:40 mark of the Day 1 video (slides for session 3B begin at slide number 112). The workshop also included a session (3C) titled, Approaches to Support the Inclusion and Clinical Study Participation of Individuals with Mental Illness (slides for session 3C begin on slide 128 and the session begins at the 00:03:45 mark of the Day 2 video).
The information gathered during the FDA workshop, in addition to comments submitted by the public, will form the basis for a report that the FDA will submit to Congress.
Why You Should View the Video and Consider Commenting
People from underserved communities — including people with disabilities — have historically been underrepresented in 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.
Too often the exclusion of people with disabilities from clinical trials is based on stereotypes about or biases against disabled people or a failure to take into account the availability of accommodations that can facilitate participation. Your voice is important to this discussion and can impact clinical trial decision making in the future!
Too often the exclusion of people with disabilities from clinical trials is based on stereotypes about or biases against disabled people or a failure to take into account the availability of accommodations that can facilitate participation. Your voice is important to this discussion and can impact clinical trial decision making in the future!
Note About Accommodations
Closed captioning and ASL are included in the videos, but note that technical difficulties interrupted ASL for a portion of the video.
Contact
For additional information, complete the Clinical Trials Transformation Initiative contact form.
Presented by Joyce Falkenhan, DNP, RN, B-C, CNRN, RN Consultant and Anne Conway, RN, BSN, MS, CCM, Director of Health Plan and Hospital Services
