Guest Column | November 29, 2023

Improving Clinical Trials Accessibility For Patients With Disabilities

By Nick Charron and Erica Parks Murray, Clarkston Consulting

Down Syndrome-GettyImages-996380100

It’s hard to overstate the importance of DE&I in clinical research. DE&I in trials helps to foster innovation, enhance decision-making, and cultivate a positive and inclusive environment when it comes to medical research and potentially lifesaving developments. As such, it’s critical to have a diverse group of individuals involved throughout the entire process, from the teams creating the treatments to the patients participating in the trials. While increasing DE&I in clinical trials is essential to all individuals, this article speaks to considerations for removing barriers and improving trial accessibility for individuals with disabilities.

The Diversity Paradox

According to the U.S. Department of Labor’s Office of Disability Employment Policy, individuals with disabilities are the third-largest U.S. market segment, after Hispanics, African Americans, and Asian Americans.1 Approximately one in four adults in the U.S. have “one or more mobility, visual, hearing, cognitive, developmental, or intellectual impairments.”2

However, globally, we know a number of eligible patients don’t participate in clinical research – and further, the data on the disability status of trial participants is rarely collected or reported. Oftentimes, individuals with disabilities who might be willing and legally eligible to participate in a clinical trial for another prevalent health condition are dismissed based on exclusionary criteria, such as psychiatric, substance use, visual, hearing, mobility, speech and communication, or other criteria.3 Take, for example, Alzheimer’s disease. Few trials for this debilitating disease have been conducted specifically for individuals with Down syndrome, despite evidence that demonstrates approximately 90% of the Down syndrome community will develop “Alzheimer’s disease or dementia by age 55.”4

There’s also evidence that suggests people with intellectual disabilities generally wish to participate in clinical trials.5 So, why is there a gap, and what can be done to mitigate it?

Combating Stigma And Bias

When it comes to inclusivity in this space, several challenges exist, including combating existing stigma and bias toward individuals with disabilities. Researchers may be hesitant to include people with disabilities in clinical trials because of concerns about their safety or the potential for their disability to interfere with the trial procedures in some way. However, that mindset is exclusionary and illegal, as “the exclusion of people with disabilities from clinical research without appropriate justification is discriminatory, is counter to federal regulations and research guidelines, and limits study generalizability.”6

Researchers and inspectors alike also may hold unconscious biases — meaning they may not be aware of the bias — against people with disabilities. As an example, if a researcher has been led to believe that all individuals with disabilities are unable to understand or consent to treatment, then the researcher might be unintentionally letting that mindset interfere with their ability to make an unbiased decision to include a participant with disabilities in the trial.

Without taking action, allowing stigma and bias toward individuals with disabilities to exist in clinical trials can have significant impacts on the future of clinical research and innovation, including:

  • Reduced access to new treatments, products, and medical devices: Clinical trials often involve cutting-edge new treatments and therapies that can potentially be lifesaving. Without a good reason for excluding individuals from the trials, people are unduly prevented from accessing these treatments through participation in a trial.
  • Lack of safety and efficacy data: Excluding individuals with disabilities can lead to a lack of data and understanding of the safety and efficacy of treatments as it pertains to people with disabilities, leaving a gap in the research and making it difficult to prove that the treatments developed are safe and effective for these individuals.
  • Increased risk of harm: Excluding individuals with disabilities from clinical trials may lead to these patients experiencing increased risk of harm from treatments that were established without them in mind.

A critical first step to improving accessibility within clinical trials for individuals with disabilities is to educate and inform key stakeholders — researchers, coordinators, sponsors, and volunteers alike. To do this, it’s critical to recognize the stigma surrounding these individuals as well as the unconscious bias that may exist for those involved with the planning and execution of clinical trials. This includes eligibility criteria, trial procedures, communications, and recruitment, at minimum:

  • Eligibility Criteria: Researchers may exclude people with disabilities due to criteria that aren’t medically necessary, like requiring participants to be able to walk or climb stairs.
  • Trial procedures: Trial procedures might be designed without consideration of whether they are accessible for participants with disabilities.
  • Communication: Researchers/inspectors may not effectively communicate with individuals with disabilities who need to use accessible language and devices.
  • Recruitment: Individuals with disabilities are not actively recruited for clinical trials, or researchers/inspectors may use recruitment methods that are not accessible to this group of people.

Changing Structural Design

Clinical trials are the bedrock of medical progress, advancing our understanding of diseases and revolutionizing patient treatment options. They offer a beacon of hope for patients seeking innovative therapies and hold the potential to transform healthcare landscapes. However, beneath the promise of progress lies an alarming reality: the systemic exclusion of individuals with disabilities perpetuating a cycle of discrimination that not only hampers medical innovation but also places the well-being of every individual at risk.

The industry has widely recognized the need for systemic changes to foster inclusivity; however, patients with disabilities are often excluded from these efforts. Improving inclusivity for patients with disabilities must start by homing in on patient recruitment/retention strategies, enhancing the infrastructure at all levels of the trial team, and incentivizing teams to use new and existing methods to support participation. This shift is not only a matter of ethics and fairness but a critical step in driving innovation and ensuring equitable healthcare access for every member of our society.

  • Site Design/Infrastructure: Improved patient recruitment and retention strategies lie at the heart of the imperative to reform the structural design of clinical trials, especially for patients with disabilities. In clinical research, the trial sites essentially decide the study makeup due to the demographics of the center, study team selection, etc. Keeping this in mind during the site selection process, we can ensure trials are run in inclusive environments, considering the background of the PI/study team and understanding the offerings and patient demographics of the clinic or center.

    One way to improve this process would be meeting and/or reviewing the CV of all site staff working on the study. Often, the team will meet with the PI and the practice manager during the site selection process, and possibly with the rest of the team during site start-up and onboarding. Understanding the team working on your project could give critical insights into the site and potential biases they could introduce to the selection process. Further, the practice of looking at patient populations and comparing them against inclusion/exclusion criteria is already widely used, especially for independent PIs at their facilities. There’s even a tool in one of the larger electronic medical records (EMR), Epic, called Slicer Dicer, which allows the investigator to put in certain parameters (i.e., inclusion/exclusion criteria) and receive an eligible patient count. Developing a similar tool that incorporates a broad array of different elements across participating centers could help identify sites with a higher proportion of target populations.
  • Patient-Centered Approach: Simultaneously, we can improve patients' comfort and understanding of a study by crafting documents with individuals with disabilities in mind, including recruitment materials, informed consent forms, and questionnaires, thereby increasing accessibility and potential patient participation. We must ensure exclusion criteria are based on solid scientific rationale, eliminating non-essential criteria that unduly restrict inclusion. A study conducted by the Cochrane Review underscores the urgency of these changes, showing that 32% of the 182 studies reviewed excluded those with a cognitive impairment.7 Without valid ethical or scientific justification, such exclusion undermines both the ethical and scientific integrity of these vital research endeavors. Further, lack of representation of people with disabilities in clinical trials, or conducting trials that don’t adequately consider people with disabilities’ unique needs, may result in those communities being less inclined to trust or participate in trials.
  • Incentivization: It’s important to use new, innovative approaches as well as reexamine existing methods in a new way to help transform the structural design of clinical trials for greater inclusivity. Initiatives like awarding grants and incentives for decentralized trials or satellite sites that prioritize accessibility and reduce patient burden can substantially broaden the participation base. Further, ensuring reasonable site accommodations, encompassing physical ease of access and specialized support mechanisms such as assisted decision-making and assistive devices, serves to eliminate barriers that may hinder participation. Additionally, adopting practices such as Assent, which is commonly employed in pediatric clinical trials, into adult trials for patients with disabilities can enhance their involvement and foster a sense of autonomy.

Without a systemic change in the way we approach clinical trial design and structure, discriminatory practices will continue, which can lead to a lack of innovation and progress when it comes to the future of clinical research and the field of medicine — putting one out of every four adults at risk. By actively embracing these strategies, we can forge a more inclusive path forward in clinical research that respects all patients' diverse needs and enables their meaningful contribution to medical advancements.

Leveraging AI/Technology

Artificial intelligence (AI) has the potential to drive meaningful change within clinical trial design, recruitment, and execution. Al can detect patterns with vast amounts of data generated by clinical trials, deriving insights and expanding knowledge way beyond human capabilities. While it has its potential downfalls and it’s still a rather new technology, there are several advantages that AI can bring to the clinical research space, particularly when it comes to diversity, equity, and inclusion.

  • Provide personalized care for individuals with disabilities. AI can be used to develop adaptive trial designs that are tailored to the specific needs of each participant.
    • The University of California, San Francisco, is using AI to develop a virtual reality simulation that will allow people with spinal cord injuries to participate in clinical trials and to experience the physical sensations of walking or running, which will help researchers assess the safety and efficacy of new treatments.8
  • Overcome bias in clinical trials. AI can develop algorithms that are blind to participant characteristics, like disability status.
    • The NIH is using AI to develop an algorithm that will identify participants with disabilities who are eligible for clinical trials based on their medical records and other data.9
  • Improve communication between researchers and participants. AI can be leveraged to develop translation tools that allow participants to communicate in their preferred language.
  • Pfizer is using AI to develop a platform that will facilitate communication between researchers and participants with disabilities in their preferred language by using tools to translate study materials and communications into multiple languages.10

While the use of AI in clinical trials involves a significant amount of educational training and awareness for those involved — as well as resource investment — it can potentially be a game changer in clinical development, enabling us to take one step closer to improved accessibility and inclusivity for all.

Instituting Regulatory Change

Heightened attention to the lack of diversity in clinical trials has led to significant changes in policies, laws, and regulations in the space to help rectify this injustice, recognizing the immense importance of representation for scientific, ethical, and humanitarian purposes. These changes are a critical step to bettering the medical industry, helping improve outcomes, and ensuring treatments are based on sound testing conducted on a representative population. However, these changes regularly exclude people with disabilities. We dive into some of the recent policy updates and legislation that has been passed targeting the improvement of DE&I efforts in research, in addition to justification as to why these efforts should be expanded to include people with disabilities, below.

  • Programs, Guidelines, and Legislation to Build on: In March 2019, the NIH made overdue and much-needed revisions to their guidelines, underscoring the significance of inclusivity in clinical research.11 These guidelines emphasize the importance of including underrepresented groups, such as women, minorities, and people of all ages. The revisions highlight the need for valid analysis, particularly in Phase 3 clinical trials, to assess and address group differences based on sex/gender and race/ethnicity; however, accounting for patient disabilities isn’t currently considered. These new policies are working to increase inclusivity, and adding provisions for people with disabilities fits with the overall spirit of these changes.

    In addition, when the Affordable Care Act (ACA) was passed it introduced Section 2709, requiring private insurers to cover routine patient costs for patients participating in clinical trials focused on cancer or life-threatening diseases.12 Historically, some health plans denied coverage for clinical trial-related expenses, hindering patient participation. This update aims to reduce financial barriers and discrimination against trial participants, making it more affordable for patients to join critical research efforts. Additionally, guidelines on payment and reimbursement to research subjects stress the importance of making certain the amount of compensation and other incentives being offered to participants doesn’t overshadow or misconstrue the potential risks associated with the trial.
  • Strategies to Increase Recruitment and Participation: Further legislation was passed in June 2022 by the U.S. House of Representatives and enacted into law under the Food and Drug Omnibus Reform Act to mandate diversity action plans as part of clinical trials.13 This was mainly in response to another bout of controversies surrounding the lack of diversity in research (for both Alzheimer's and COVID-19 trials), illuminating the enduring gaps in representation across the field. Starting in 1985, the FDA began a voluntary effort to promote diversity in trials, a largely unsuccessful effort, demonstrating that updating policies and introducing new legislation is great, but must be enforced and backed by efforts to tackle the root causes of the issues. Some such ideas include:
  • Financial Support for Participants: This always has been a tricky situation, as you must balance the need to adequately compensate participants for their time and expenses related to the trial while avoiding a coercive effect. However, this issue can be a major impediment to individual participation in a given study. Ensuring that patients from all backgrounds can participate and aren’t unduly affected by their involvement in a trial should be a significant consideration.
  • Enforce Diversity Action Plans: Now that the 2022 legislation is in place requiring that all Phase 3 studies must prepare a diversity action plan, we need to back them up with real incentives (like tax credits for companies, tying grants to historical performance in meeting these goals, etc.) and consequences (minimum threshold to be considered by certain journals, financial penalty or mandated Phase 4 follow-up study with early inclusion of underrepresented population, etc.). This will help ensure these action plans remain realistic and that companies continue to prioritize the inclusion of marginalized groups.
  • Standardize Tracking and Reporting of Baseline Study Demographics: This effort would be relatively simple to set up, as all this information is already captured in clinical trials. It could be beneficial to more prominently feature tracking and study demographics in papers, articles, and, most importantly, on websites like to bring transparency to which populations are included in research efforts. This can assist researchers, clinicians, and others who review these papers in comprehending the study's limitations, ensuring that this concern remains a priority.

Ultimately, the overarching objective is establishing a more robust and sustainable framework for promoting inclusivity in medical research and drug development. This is essential because previous voluntary efforts have consistently fallen short and should be reevaluated to fill the existing gaps in literature and clinical understanding, with the aim of reducing existing disparities.

Looking Ahead

For clinical trials to truly become more inclusive of individuals with disabilities, it’s imperative that those involved with trials — from design to recruitment to execution — take actionable steps to raise awareness and create a more accommodating, accessible environment. Organizations involved with the design and execution of clinical trials should consider prioritizing training and education for all staff on the criticality of running inclusive clinical trials. They also can consider hiring individuals with disabilities to work at their sites, so those who run trials can better understand the needs of participants with disabilities and provide them with the support they require.

It’s also important to raise awareness about active or upcoming clinical trials among individuals with disabilities to not only increase their participation but also help them become greater advocates. Creating public education campaigns, reaching out to disability organizations, and partnering with healthcare providers are great places to start.

Finally, it’s vital to share wins and celebrate progress in this space. We should celebrate the stories of individuals with disabilities who have successfully participated in clinical trials to further raise awareness of how important their inclusion is to drug development and effectiveness. And, when possible, encourage individuals with disabilities who have participated in trials to share their own stories and experiences; this can help to break down unfounded misconceptions and stereotypes about individuals with disabilities in clinical trials. It also can contribute to influencing others to participate; one Gartner study showed that taking social cues from peers increases the likelihood of experiencing a change or shift in behavior by 30%.14

Improving accessibility and inclusivity for individuals with disabilities in clinical trials is not just the right thing to do, it is also in the best interests of the medical community and the public at large. By including individuals with disabilities in clinical trials, researchers can develop more effective treatments and therapies for all individuals.


  1. Office of Disability Employment Policy. Inclusion@Work: A Framework for Building a Disability-Inclusive Organization. U.S. Department of Labor.
  2. Disability and Health Promotion. Disability Impacts All of Us. Centers for Disease Control and Prevention.
  3. Plosky, W.D., Ne’eman, A., Silverman, B., et al. (2022, October). Excluding People with Disabilities from Clinical Research: Eligibility Criteria Lack Clarify and Justification. Health Affairs.
  4. Alldred, M.J., Martini, A.C., Patterson, D., et al. (2021, October 10). Aging with Down Syndrome—Where Are We Now and Where Are We Going? Journal of Clinical Medicine.
  5. McDonald, K.E., Conroy, N.E., Olick, R.S., et al. (2017, December 13). A quantitative study of attitudes toward the research participation of adults with intellectual disability: Do stakeholders agree? Disability and Health Journal.
  6. Plosky, W.D., Ne’eman, A., Silverman, B., et al. (2022, October). Excluding People with Disabilities from Clinical Research: Eligibility Criteria Lack Clarify and Justification. Health Affairs.
  7. Schwartz, J.K. & Unni, E. (2021, July 26). Inclusion of People with Disabilities in Research to Improve Medication Adherence: A Systematic Review. Patient Preference and Adherence.
  8. Fernandez, E. (2019, October 11). UCSF Launches Artificial Intelligence Center to Advance Medical Imaging. University of California San Francisco.
  9. NIH. (2022, January 28). Notice of Special Interest (NOSI): Validation of Digital Health and Artificial Intelligence Tools for Improved Assessment in Epidemiological, Clinical, and Intervention Research.
  10. Pfizer. (2023). Meet the New Digital Assistants Transforming Patient Medical Information.
  11. NIH. (2019, March). Guidelines for the Review of Inclusion on the Basis of Sex/Gender, Race, Ethnicity, and Age in Clinical Research.
  12. American Society of Clinical Oncology. (2022). Affordable Care Act Provision Requiring Insurance Coverage of Clinical Trials.
  13. Hwang, T.J. & Brawley, O.W. (2022, October 13). New Federal Incentives for Diversity in Clinical Trials. The New England Journal of Medicine.
    See also: Auchincloss, K. & Ashley, D.D. (2023, May 23), Clinical Trial Diversity, Flexibility Championed By The Food And Drug Omnibus Reform Act. Clinical Leader.
  14. Bryan, J. (2019, March 22). Uncover What’s Really Driving Employee Behavior. Gartner.

About The Authors:

Nick Charron is a business analyst at Clarkston Consulting, serving clients in the life sciences, consumer products, and retail industries. His previous experience as a clinical research coordinator at Duke University and the University of Chicago focused on study design and management, process optimization, and regulatory compliance and guidance in clinical research. He holds an MBA and MSBA from Penn State University.

Erica Parks Murray is a manager at Clarkston Consulting with more than two decades of experience in organizational change management, multi-national system deployment, enterprise information technology, and organizational effectiveness. She guides clients within the pharmaceutical, biotech, and life sciences sectors and has dedicated the recent years of her career to the development of human-centered approaches in digital models, capabilities, and structures. Parks Murray is passionate about the advancement of decentralized clinical trials and diversifying clinical study structures to improve innovation and participant inclusivity.