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NCD-23-02: Query into the Absence of People with Disabilities in Clinical Trials

Closed Closed March 22, 2023 Opportunity NCD-23-02 ☆ Save

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• Award ceiling$30,000
• Award floor$30,000
• Total funding$30,000
• Expected awards1
• Cost sharingNot required
• Funding typeCooperative Agreement

Key dates

Who can apply

This opportunity was open to any type of organization.

• Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

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Is this a realistic fit?

• No cost sharing or match is required.

What the grant funds

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.

Category: Other.

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