Query into the Absence of People with Disabilities in Clinical Trials

Query into the Absence of People with Disabilities in Clinical Trials Background People with disabilities are at a higher risk for numerous health conditions compared to the general population. For example, clinical trials for Alzheimer’s exclude people with Down syndrome, even though approximately 90% of people with Down syndrome will develop Alzheimer’s disease or dementia by age 55.[1] Not only are people with disabilities (PWDs) at higher risk for many conditions and diseases compared to the general population, disability itself can change the presentation and/or management of a disease, and clinicians need to be aware of these differences.[2] The exclusion of PWDs in research has been well-documented.[3] The exclusion of people with psychiatric, substance use, and intellectual disabilities is especially prevalent. Eligibility criteria affecting people with disabilities included exclusions for psychiatric (68 percent), substance use (62 percent), HIV or hepatitis (53 percent), cognitive or intellectual (42 percent), visual (34 percent), hearing (10 percent), mobility (9 percent), long-term care (6 percent), and speech and communication (3 percent) disability-related domains. Documented justification was provided for only 24 percent of these exclusions.[4] The discriminatory practices continue partly due to stigma and bias of PWDs and vague, generalized, and subjective exclusion criteria that is often copied and pasted from one study to another. Phrases such as: · “In the investigator’s opinion, [participants] are well-motivated, and capable.”; · “Subject is generally frail, or has any (medical) condition that, in view of the investigator or the sponsor’s responsible medical officer, is likely to prohibit or limit further participation in the study…; · “Subject has any condition that confounds the ability to interpret data from the study.”; · “Is judged by the Investigator to be inappropriate for the study.”; · “Any other reason the Investigator deems exclusionary.” Given the pervasive stigma and bias of PWDs combined with a clinical trial investigators ability to exclude anyone from a research study, it should be no surprise that PWDs are not well represented in clinical trials. Some investigators have explicitly excluded people with intellectual disabilities by requiring subjects pass cognitive assessments or requiring that subjects know how to read and write.[5] Few studies offered a reasonable accommodation so that PWDs could participate. (Plosky at 1426) This, despite the fact that Universal Design[6] recommendations for medical research have been available for over a decade.[7] Researchers who receive federal funding also have a legal obligation not to discriminate against PWDs under Section 504 of the Rehabilitation Act. Whether the exclusion of PWDs in clinical trials is explicit or implicit, such exclusion is a possible violation of Sec. 1557 of the Patient Protection and Affordable Care Act, which states that “an individual shall not be excluded from participation in, be denied the benefits of, or be subjected to discrimination on the grounds prohibited under Title VI of the Civil Rights Act of 1964, 42 U.S.C. 2000d et seq. (race, color, national origin), Title IX of the Education Amendments of 1972, 20 U.S.C. 1681 et seq. (sex), the Age Discrimination Act of 1975, 42 U.S.C. 6101 et seq. (age), or Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. 794 (disability), under any health program or activity, any part of which is receiving federal financial assistance; any program or activity administered by the Department under Title I of the Act; or any program or activity administered by any entity established under such Title.” Report Purpose The purpose of this report is to address the explicit and implicit exclusion of people with disabilities in clinical trials, the repercussions of exclusion on the disability community, the legal requirements of clinical trial investigators to include PWDs in clinical trials and repercussions for not abiding by those requirements. The final report will provide recommendations and promising practices to increase the acceptance and participation rates of people with disabilities in clinical trials. Research Questions · How can clinical trial researchers, administrators and universities ensure meaningful participation of PWDs in clinical trials? · What promising practices exist to combat conscious and unconscious bias which leads to the exclusion of PWDs in clinical trials? · What recommendations need to be made to federal agencies to ensure inclusion of PWDs in clinical trials? · What is the value of having people with disabilities included in clinical trials? · What are the consequences of not having people with disabilities included in clinical trials? Time Period 6 months The deliverable for this project will include: A detailed preliminary framing paper. A revised framing paper incorporating input from NCD Council members and staff. A first draft report incorporating initial findings, conclusions, and recommendations that can be drawn from the examination. A final report of no more than 100 pages (not including endnotes or appendices) incorporating input from NCD Council members and staff. The final report must contain an executive summary with key findings and key recommendations; and specific sections on methodology; all findings; and all recommendations, organized according to the entity to which they are directed. A brief “Report Highlights” document for each report to succinctly and in plain language encapsulates the report’s scope and purpose, major findings, and recommendations, and contains a link to the full report at the bottom. For an example of a Reports Highlights Page, refer to: https://ncd.gov/publications/2013/10242013
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