HealthDay News — People with disabilities are commonly excluded from clinical trials, according to a report published in the October issue of Health Affairs.
Willyanne DeCormier Plosky, PhD, from Brigham and Women’s Hospital in Boston, and colleagues analyzed 97 recent interventional protocols in 4 therapeutic areas registered on ClinicalTrials.gov to assess disability status of trial participants.
The researchers found that 85% of protocols allowed broad investigator discretion to determine eligibility, whereas only 18% explicitly permitted people with disabilities to use forms of support (e.g., supported decision making or assistive devices) to facilitate study participation. Eligibility criteria limiting participation of people with disabilities included exclusions for psychiatric (68%), substance use (62%), HIV or hepatitis (53%), cognitive or intellectual (42%), visual (34%), hearing (10%), mobility (9%), long-term care (6%), and speech and communication (3%) disability-related domains. Only 24% of these exclusions provided documented justification.
“We recommend greater scrutiny of study eligibility criteria, scientific or ethical justification of exclusions, and accessible study design,” the authors write.
One author disclosed financial ties to the Takeda Pharmaceuticals Ethics Advisory Council.