People with disabilities are commonly excluded from clinical trials, according to a new study conducted in the US.
Investigators from Brigham and Women’s Hospital, the second largest teaching hospital of Harvard Medical School, found that the language used in protocol eligibility criteria for clinical trials frequently allowed for the exclusion of people with disabilities. In fact, only 18% of protocols explicitly allowed people with disabilities — the largest minority group in the US — to participate in trials.
Approximately 25% of adults in the US have one or more cognitive, visual, hearing, mobility, development or intellectual impairment and many people will develop a disability throughout their lives; however, their exclusion from clinical trials is an ongoing situation. One example shows that almost 90% of people with Down syndrome will develop Alzheimer’s disease by the age of 55, however, few Alzheimer’s trials include this group of people specifically.
The study has called for greater recognition of how people with disabilities are underrepresented. It reports that the eligibility criteria of most studies excluded people with a range of disabilities — psychiatric, substance abuse, HIV or hepatitis, cognitive or intellectual, visual, hearing, mobility and others. Only 18% of trials permitted people with disabilities to use accommodations such as assistive devices, and few protocols provided any justification for these exclusions. Where justification was present, it was often ambiguous and subjective.
The study’s co-author outlined that the exclusion of people with disabilities from clinical research is counter to US federal regulations and research guidelines, reduces access to the potential benefits of these trials, limits the measure of how useful study results are and is discriminatory.
The investigators, in conclusion, have recommended greater forethought into study participant inclusion, adaptations for those included, and reasoning for those excluded. They also advocate for more thoughtfully written justifications which could potentially facilitate oversight of these exclusions to determine whether or not they can be overcome with modifications. They have also said that they believe criteria should be as inclusive as possible and only as restrictive if necessary to avoid the profound implications of these exclusions.
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