Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification

Area of Science:

• Clinical research methodology
• Disability studies
• Health equity

Background:

• Exclusion of individuals with disabilities from clinical research is discriminatory and limits generalizability.
• Data on disability status in trial participants is infrequently collected or reported, indicating an understudied area.

Purpose of the Study:

• To analyze the eligibility criteria of interventional clinical trial protocols concerning the exclusion of people with disabilities.
• To assess the frequency and justification of disability-related exclusions in clinical research.

Main Methods:

• Analysis of 97 recent interventional protocols registered on ClinicalTrials.gov across four therapeutic areas.
• Examination of eligibility criteria for explicit permissions regarding support for participants with disabilities.
• Quantification of specific disability-related exclusions and assessment of documented justifications.

Main Results:

• 85% of protocols granted broad investigator discretion for eligibility, while only 18% explicitly allowed support for disabled participants.
• Common exclusions involved psychiatric (68%), substance use (62%), HIV/hepatitis (53%), and cognitive/intellectual (42%) disability domains.
• Documented scientific or ethical justification was provided for only 24% of these exclusions.

Conclusions:

• Clinical trial eligibility criteria frequently exclude people with disabilities without adequate justification.
• Recommendations include increased scrutiny of exclusions, mandatory justification, and the adoption of accessible study designs.
• Addressing these barriers is crucial for promoting inclusivity and enhancing the generalizability of clinical research findings.