In April 2022, FDA issued draft guidance for the clinical trials industry entitled, “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials.” Over the years, FDA has issued numerous recommendations to improve the racial and ethnic diversity in clinical trials with the goal of ensuring that clinical trials are representative of and generalizable to the larger population. As a result, companies seeking marketing approval will be required to submit a diversity plan. To meet these requirements, companies will need to articulate their demographic goals for patients recruited, explain their rationale, and provide an action plan for how these goals will be accomplished.
Even though minorities make up nearly 40% of the population of the United States,
participants of color, women, LGBTQ+ individuals, and the elderly have been historically underrepresented in clinical research. While there is encouraging movement towards the democratization of clinical trials, relatively little attention has been paid to the need to make clinical trials more accessible. This is critically important for the nearly 60 million adults in the US living with one or more visual, auditory, cognitive, communicative, physical, or emotional limitations, many of whom are already part of the 40% referenced above.
Built environments, i.e., the material and cultural world that surrounds us, determines our ability to navigate the world, and, you guessed it, participate in clinical trials. If the design of a clinical trial does not consider how the built environment impacts potential participants, it effectively prematurely excludes potential participants. It also sends a clear message that this population is not considered an equally deserving benefactor of clinical research.
Some might suggest that improved accessibility of clinical trials is a luxury instead of a necessity. The reality is that any dataset that is not representative of a diverse population is not as scientifically accurate as it would be if it included the demographics excluded. A reasonable solution, then, starts with addressing very tangible barriers through purposefully designing inclusive trials and considering how every aspect of a trial impacts a participant.
Let’s look at a few concrete examples of how we inadvertently make clinical trials less accessible:
- Example A: A visually impaired adult is living in a mid-sized city with limited public transportation options. They’re unable to drive, and light rail and rideshare aren’t options. So, in order to participate in a study, they’ll need to ask a friend or loved one to take off work to drive them to and from their study visit.
- Example B: A young adult with Duchenne Muscular Dystrophy, a condition characterized by progressive muscle degeneration and weakness, has expressed interest in participating in a clinical trial. To complete the informed consent, they’re asked to provide a wet ink signature.
- Example C: A geriatric adult with multiple sclerosis is returning to their clinical trial site for a follow up visit. Though they’re able to drive, mobility is an issue and they’re often confined to a wheelchair. The parking lot at the trial site has relatively few handicapped spots and the doors to the building do not have a push-button access switch.
Though there have been recent developments with respect to bringing clinical trials to a participant’s home through home health visits and telemedicine, there’s still plenty of room for improvement. Here are some simple strategies we can employ to make clinical trials accessible to a wider population:
- Strategy A: Talk with the patient population intended to benefit from a clinical trial. Get to understand their unmet needs, what impacts their quality of life, and their preferences. Be thoughtful when designing your clinical trial protocol. For example, don’t simply provide transportation to and from a clinical trial site for someone with vision or mobility challenges. Make sure they have support along their journey. This includes transportation from their home to the waiting room at the clinical trial site and back.
- Strategy B: When asking patients to complete a task, be sure you understand what is and is not feasible. When requiring a wet ink signature, consider whether a patient is able to grip a pen. Do they have a printer, ink, and scanner at home to print, sign, and return? If not, are you asking someone to travel to a copy shop when the task could more easily be completed with the assistance of technology like electronic consent (eConsent)?
- Strategy C: Have clinical research associates (CRAs) evaluate clinical trial site accessibility. Are there curb cut outs from the parking lot to the sidewalk? Is there a touch-free means of opening the door? Is the clinical trial site located in a three-story walk up?
- Strategy D: Are all the visits required to be on-site? Is there flexibility in when and where participants can complete study activities in case they are in pain, do not have reliable support, or have an emergency that is unavoidable?
- Strategy E: Have conversations with each participant prior to visits about any sensory or communication strategies that work best for them and their support system.
We can reduce barriers and burdens to participation through intentional consideration of the realities faced by patients, thereby making research accessible to a broader patient population. Not only does this contribute to more equitable science, it also benefits everyone, as it pushes the industry to make less assumptions about capabilities and provide more flexibility to potential participants as a whole.
Written by Richie Kahn, Co-Founder & Principal at Canary Advisors and Kristy Birchard, Director, Canary Advisors
Additional Resources:
https://www.nature.com/articles/d41586-023-00469-4
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