There are people in your life who influence and shape how you see the world. For me, one of these people is Terry Moakley, a warm and welcoming family friend, a veteran of the Vietnam War, and a fervent advocate for people with disabilities. After he became a quadriplegic as a result of an injury, he began a decades-long career dedicated to improving disability access.
In 2018, 17.7% of Australians lift with disability. This number is likely to increase as Australia’s population increases. Purely as a numbers game, researchers can ill-afford excluding these people. For many trials, particular experiences, comorbidities, and vulnerabilities make including people with disability necessary. Historically, they have been excluded to avoid complexity and risk. But experience shows that people with disability are happy to participate. They want to contribute, and in some cases, it might be the only way for them do I access access treatment. The proposed revision to Section 4 of the National Statement urges researchers and research ethics review bodies to include these traditionally excluded groups. It may require accommodation/modification and mitigation but completeness, respect, agency, and self-determination are required to introduce the principles of justice, respect for persons and merit.
About eight years ago, Terry died at the age of 69. His memory inspires me to create real change in a world built against him. His devotion to equity constantly motivates me to bring that change to the clinical trial industry, where I have worked for more than two decades.
Despite constituting the largest minority group in the U.S. and regularly expressing interest in participating in clinical trials, people with disabilities remain heavily excluded from the process. And it’s not just quadriplegics like Terry. He represents one of many groups of people with disabilities that are often left out of the process. Recently, another First Opinion author shared a powerful essay about the potential of including more people with Down syndrome in research for Alzheimer’s therapies. In that article, she cited an advocate with Down syndrome who warmly expressed to Congress his willingness to contribute to clinical research, reinforcing how much enthusiasm can exist in underrepresented groups — many of whom have unique attributes that could accelerate clinical discovery.
However, even though these groups can bring insights to the table, disability exclusion is often systemic. An October 2022 Health Affairs study conducted by researchers at Harvard, Brigham and Women’s Hospital, Mass General Brigham, Columbia, and the University of Utah examined the eligibility criteria of 97 trials, specifically looking at instances of disability exclusion. Of the protocols they examined, the research team found that those with disabilities, psychiatric or substance use disorders, cognitive or intellectual disabilities, and various impairments were regularly excluded from participation.