Disability inclusion in clinical trials and equity in outcomes

Many agree that disability inclusion in clinical trials is a worthy pursuit, but the historical significance and future impact of pursuing this goal is relatively unexplored. Here, we peel back the layers of this vital mission.



One in seven people – or over one billion people globally – have a disability. (1) People with disabilities have been described as “the largest underrepresented group in the world”, (2) despite being a huge population that anyone could potentially join at any given time. Due to obstacles such as unnecessarily restrictive protocols and inaccessibility of trial sites or information materials, (3) (4) (5) it can be difficult for people with disabilities to have the same opportunities to take part in scientific studies as the rest of the population.

“Pre-existing conditions are often considered exclusion criteria in clinical trials, even if the condition would have little bearing on the treatment being tested or the trial outcomes.” (5)


Disability inclusion in clinical trials: why it matters, and what is being done

Access to study participation is not simply a matter of equal opportunity; the effects of inclusion vs exclusion are far further reaching. Barriers to clinical trial participation can impede fair access to novel potential treatments for this demographic (and therefore the generalizability of drug safety and efficacy data for people with disabilities), and consequently perpetuate existing health inequity associated with disability. (1) (2) (6) (7)

“As disability often correlates with other inequalities such as poverty, exclusion of disabled individuals from a clinical trial can result in the study population being unrepresentative of the general population in more ways than one.” (5)

Particularly as people with disabilities have frequently been excluded from past initiatives aiming to increase the diversity of research study populations, (8) the time is ripe for meaningful progress – and thanks to Bristol Myers Squibb (BMS) and Disability Solutions, progress may well be on the way. Recently, the two organisations launched a new Disability Diversity in Clinical (DDiCT) Trials initiative. The first objective is to develop recommendations on how to “effectively improve access, engagement, speed of enrolment, and participation of people with disabilities in clinical trials, to ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies.” (2)


Disability inclusion is a key component of patient centricity and therapeutic advances

“There is a complete lack of disability-related information published about the participants in clinical trials. This is very difficult to see, particularly when the trial is about something that affects the whole population, like COVID-19. The COVID-19 pandemic has highlighted the importance of pre-existing conditions and comorbidities and how these affect not just the risk of contracting an illness, but how it manifests, and the extent to which you respond to therapies. I think the pandemic has highlighted the importance of collecting this kind of information – and reporting it.” – Dr Becca Wilson, Research Fellow at the University of Liverpool, and disability activist (5)

This work has significant potential to move Pharma closer to a future where patient centricity is the mainstream. To bring this hypothetical future into reality, initiatives addressing the specific inclusion needs of different ‘types’ of patient are vital; if clinical trials or engagement activities are not inclusive of all different kinds of patients, one cannot hope to describe them as truly patient-centric. Patient centricity is, at its core, about putting patients’ needs first and that cannot fall apart as soon as a potential participant in a trial or engagement activity has needs beyond the basic considerations applicable to all patients.

What’s more, given that people with disabilities are present across all therapy areas and are at particularly high risk of comorbidities compared to the able population, (3) Pharma leaders must remain aware    that to improve disability inclusion is to foster the development of more relevant, appropriate, and highly-valued treatments across all therapy areas.


Efforts made now will boost the value and impact of future medicines

The scale of the positive impact of disability inclusion initiatives in clinical trials is far broader than at first glance. As research communities acquire and share expertise in how to include disabled participants, involving these patients in clinical trials and insight-seeking collaborations will start to reap extensive rewards.

For instance, disability-inclusive clinical trial recruitment will be better understood and therefore more easily implemented, resulting in better recruitment to and retention in inclusive studies. Investigators will consequently be able to collect more diverse (and therefore more representative     ) data with greater ease and speed, speeding time to submission for product approval and market access. Developing drugs in this way will enable the pharmaceutical industry to deliver higher value products due to the more realistic nature of the demographics on which the drug was tested, and thus the broader generalizability of drug safety and efficacy data. Ultimately, healthcare professionals will be empowered to prescribe treatments for a wide range of patients with greater scientific justification, boosting the chance of people living with disabilities receiving safe and effective care.

“Inclusive … research is a necessity, not a luxury, if research is to benefit all the communities it seeks to serve. It requires close engagement with under-served groups and attention to aspects of study topic, design, delivery, analysis and dissemination across the research life cycle.–  Witham et al.” (9)


Patient and caregiver engagement is key to understanding meaningful inclusion

The new BMS initiative is looking ahead, but what can we learn from past successes? A great example of working towards disability-inclusive clinical trials comes from the UK Fragile X Society, who conducted a study to better understand barriers to, and how best to facilitate participation in, medication trials for people living with Fragile X syndrome, an inherited form of intellectual disability. While medication is not used to treat Fragile X per se, associated challenges such as anxiety may be managed via pharmaceuticals, (10) meaning this population could stand to gain from access to investigational treatments relevant to their disability.

By engaging with people living with Fragile X and their caregivers to hear their views on and experiences of taking part in clinical trials, researchers were able to learn how this demographic could be meaningfully supported in pharmaceutical research. Many suggestions were made regarding how to overcome barriers to trial participation, such as the provision of accessible study information for families in a range of easy-to-understand formats, particularly regarding any potential safety issues (N.B., information that is accessible for the average lay person does not equate to accessible for someone living with intellectual disability – accessibility levels must be tailored for the intended audience). By collaborating with people with disabilities and their caregivers to learn from this kind of insight, pharmaceutical companies could develop impactful strategies to make a meaningful difference to the inclusion of people with disabilities in drug development research.



Disability inclusion in clinical trials is a key step towards addressing the specific health inequity faced by the one billion people living with disabilities worldwide – a group that any currently non-disabled person could find themselves joining in a split second. While initiatives to boost disabled presentation in clinical trials are encouraging, they remain few and far between, and those working in the pharmaceutical industry would do well to proactively strive for designing studies in a more inclusive manner (see below for guidance on doing so from the National Institute of Health Research). For basic fairness, for drug development integrity, for safe and effective medical care, the justification is clear.



  1. What are the characteristics / demographics of the population which your research looks to serve?
  2. How will your inclusion / exclusion criteria enable your trial population to match the population that you aim to serve?
  3. Justify any difference between your projected trial population and the population you aim to serve
  4. How will your recruitment and retention methods engage with under-served groups?
  5. What evidence have you that your intervention is feasible and accessible to a broad range of patients in the populations that your research seeks to serve?
  6. Are your outcomes validated and relevant to a broad range of patients in the populations that your research seeks to serve?


Click here to find out more about the fantastic new initiative from BMS and Disability Solutions discussed in this blog post, or check out this article from our team to learn about what Pharma can do to address unmet health literacy needs for people living with intellectual disabilities.



  1. Disability and health [Internet]. Who.int. 2021 [cited 15 August 2022]. Available from: https://www.who.int/news-room/fact-sheets/detail/disability-and-health
  2. Bristol Myers Squibb. Bristol Myers Squibb Launches Disability Diversity in Clinical Trials (DDiCT) Initiative to Improve Healthcare Outcomes for People with Disabilities. 2022.
  3. Schwartz J, Unni E. Inclusion of People with Disabilities in Research to Improve Medication Adherence: A Systematic Review. Patient Preference and Adherence. 2021;Volume 15:1671-1677.
  4. Peachey C. Bristol Myers Squibb aims to improve disability diversity in clinical trials [Internet]. European Pharmaceutical Review. 2022 [cited 15 August 2022]. Available from: https://www.europeanpharmaceuticalreview.com/news/173353/bristol-myers-squibb-aims-to-improve-disability-diversity-in-clinical-trials/
  5. How to achieve inclusivity and diversity in medical research: insights from a disability activist [Internet]. The Publication Plan. 2021 [cited 15 August 2022]. Available from: https://thepublicationplan.com/2021/05/05/how-to-achieve-inclusivity-and-diversity-in-medical-research-insights-from-a-disability-activist/
  6. Younossi A, Sanhai W, Shah S, Chang C, Overman J. Enhancing clinical trial diversity [Internet]. Deloitte Insights. 2021 [cited 15 August 2022]. Available from: https://www2.deloitte.com/uk/en/insights/industry/life-sciences/lack-of-diversity-clinical-trials.html
  7. Rubio C, Schliebner S. Examining the Current Value of ClinicalTrials.gov Listings for Patients and the Public [Internet]. Applied Clinical Trials Online. 2020 [cited 15 August 2022]. Available from: https://www.appliedclinicaltrialsonline.com/view/examining-the-current-value-of-clinicaltrials-gov-listings-for-patients-and-the-public
  8. Swenor B, Deal J. Disability Inclusion as a Key Component of Research Study Diversity. New England Journal of Medicine. 2022;386(3):205-207.
  9. Witham M, Anderson E, Carroll C, Dark P, Down K, Hall A et al.
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