Clinical Trial Inclusion of People with Disabilities

People with disabilities, representing approximately 16% of the global population, remain persistently underrepresented in clinical research including clinical trials. Current guidance on disability inclusion in clinical trials remains voluntary and inconsistently applied, and enforceable standards are needed. A targeted recruitment program for individuals with schizophrenia achieved approximately a 40% increase in participant enrollment, demonstrating that disability-inclusive clinical research is operationally achievable. Most people with disabilities are fully capable of participating in clinical trials when reasonable accommodations are made, and exclusions are frequently not scientifically justified. Exclusion operates in two forms: explicit exclusion through eligibility criteria and implicit exclusion through inaccessible study designs, procedures, and environments. Exclusion of people with disabilities from trials is often based on incorrect assumptions that impairment prevents participation, rather than on scientific justification. People with Down syndrome face a 90–100% risk of developing Alzheimer's disease after age 65, yet have been systematically excluded from Alzhei…