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.
Terry was a champion for the often-overlooked disability community. Over the years, he helped set the standards for public transportation in New York City, contributing to the codification of accessible design.
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.
People with disabilities are often excluded on the basis of either ethical reasons like added burden or disadvantages, or scientific reasons like increased medical risk. There are certainly some occasions in which the exclusion is justifiable. But the current industry standard for inclusion criteria allows for broad exclusions rather than inclusive writings that give specific reasoning and prevent discrimination.
Undeniably, this results in a lack of generalizable trial findings. It also contradicts laws put into place to protect those with disabilities from unjustified discrimination.
Thankfully, through the efforts of researchers and advocates, we’re seeing a greater push to address this lack of inclusivity.
By redesigning trial accommodations, eligibility criteria, and consent forms, we can build more inclusivity in the future of research and eliminate wrongful exclusion.
In 2011, researchers Ann Williams and Shirley Moore proposed the Universal Design of Research as a way to “design research so that all people can be included as potential participants, to the greatest extent possible, without the need for adaptation or specialized design.” The concept of universal design is nothing new. Curb cuts, wheelchair ramps, and large, color-contrasting prints are all examples of accessible designs.
If universal design can be implemented to enable accessibility in our day-to-day, why not in trials? At present, just 18% of trials explicitly allow patients to utilize forms of support (such as canes, hearing aids, or other assistive devices) to complete a trial. The Universal Design of Research strategy suggests that by redesigning studies with accommodating options from the get-go, we can avoid these issues of exclusion on the basis of accessibility limitations.
Trial designs with thoughtful, universal accessibility in mind could range from transportation for those with mobility issues to study instruments that enable visually impaired people to use them without assistance, or to broader options for collecting symptom reports that span multiple avenues of communication.
Certainly, there is no single fix that modifies every trial to every disability out there. Yet by becoming dedicated to approaching trials with universal design in mind, disability accommodations can become the norm, and no patient will have to wonder whether they can be included in receiving treatment because of a study’s limitations.
Enabling accessible participation removes a huge barrier to people with disabilities from participating in trials, but even with a thoughtfully designed trial, inaccessible consent stands in the way for many medically eligible patients.
Half of all people with Down syndrome in their 60s and 30% of people with Down syndrome in their 50s have Alzheimer’s. Yet very few Alzheimer’s trials include people with Down syndrome. It is a population that should be prioritized, given the drastic overrepresentation of the disease, and nevertheless is continuously left out of innovative treatment opportunities.
An ongoing blocker to integrating more people with Down syndrome is the rigid consent processes. At present, one-third of trials deem individuals with intellectual disabilities directly ineligible for participation on the basis of their diagnosis or capacity to provide consent. If you include the number of studies that indirectly exclude that population through limitations like reading ability, it soars up to three-quarters of trials. In fact, a study published in the Disability and Health Journal found that only 12.7% of studies “explicitly included adults with intellectual disability” when it came to legally authorized consent.
But there are ways to enhance consent forms to make them more accessible without compromising people’s ability to consent. Consent forms are fraught with medical jargon; they’re difficult for anyone to understand. There are innovative, creative ways to present trial information that are accessible to a wider range of patients, and it is due time we implemented them.
One way consent forms might be made more accessible is to condense the information into a video format that not only clearly outlines the effects of the trial, but also gives the patients visuals of what the treatment will look like. In fact, it could be even simpler than that, like using more images in the form itself or incorporating audio-visual tools.
Not every trial is the right fit for every person. But if a trial calls to exclude a patient with specific disabilities, there should be a good reason. Yet many trial protocols use broad exclusion language, leaving it to the investigator to personally decide, patient by patient, who fits a vague description of eligible and who does not.
The October 2022 Health Affairs study found that 85% of trial protocols assigned investigators the ability to exclude patients using “broad discretion in determining eligibility,” meaning subjective decisions were made on a patient’s eligibility based on nonspecific language. A whopping 93% of protocols excluded patients with “other chronic conditions” without specifying the conditions that fall into that category, and few provided justifications. Rather than carrying on with eligibility defined with vague subjectivity, trial protocols should be written with the intent for inclusion. More forethought into inclusion and thoughtfully written justifications would allow for more insight into the necessity of inclusion and perhaps even enable modifications to the study to overcome the limitations.
The influence that Terry Moakley had in his lifetime is proof that change is possible and within reach. Now, as I continue to push for inclusion in my career, I hope to carry on his legacy and continue to advocate for patients with disabilities. I want to strive for a reality where it is no exception to include individuals with disabilities in research, where medicine is safe and effective for all, and where drugs on the market are generalizable to the entire population, regardless of differences between us.
Liz Beatty is co-founder and chief strategy officer at Inato.
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