The COVID-19 pandemic led researchers to take a hard look at who is most often represented in clinical trials. Efforts to be more inclusive of women, individuals of various ethnic and racial identities, and patients of different ages have been implemented as a result, according to an article published in The New England Journal of Medicine.

Swenor B, Deal JA. Disability inclusion as a key component of research study diversity. New England Journal of Medicine. 2022;386(3):205–207.

 

People living with disabilities, however, are still fighting for adequate representation in research—and, consequently, access to effective medical interventions.

 

Patients with disabilities excluded from research

Despite the progress researchers have made in diversifying research study populations, further work is needed to include more people with disabilities. According to research published by Patient Preference and Adherence, they comprise about 15% of the world’s population.

Schwartz JK, Unni E. Inclusion of people with disabilities in research to improve medication adherence: a systematic review. Patient Preference and Adherence. 2021;15:1671–1677.

 

Some of the various ways that patients with disabilities get excluded from studies were revealed by a 2022 investigation published by Health Affairs.

DeCormier Plosky W, Ne’eman A, Silverman BC, et al. Excluding people with disabilities from clinical research: eligibility criteria lack clarity and justification. Health Affairs. 2022;41(10):1423–1432.

 

Researchers analyzed 97 interventional protocols in four therapeutic domains for studies registered with ClinicalTrials.gov.

The data showed that only 18% of protocols explicitly allowed people with disabilities to use accommodations—including assistive devices and supported decision-making—so they could participate in the studies. For 85% of the protocols, investigators had broad discretion in defining the eligibility criteria.

The most common exclusions related to disability domains were for psychiatric problems (68%) and substance use (62%), followed by HIV or hepatitis (53%), cognitive or intellectual impairments (42%), and visual disability (34%). Individuals with hearing (10%), mobility (9%), long-term care (6%), and speech and communication (3%) issues could also be excluded. Only about one-quarter of these exclusions were supported by documented justification.

Considering how many Americans living with disabilities fall under these categories (at least 25%), these statistics are no small matter. The authors of the Health Affairs article voiced their concerns about these findings.

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.

Exclusionary eligibility criteria can also have consequences for the health and well-being of those with disabilities.

 

Importance of inclusion

People living with disabilities in the US have a higher rate of unmet health needs than Americans who are without disabilities.

According to The New England Journal of Medicine, the prevalence of disability is growing as a result of COVID-19 and the aging population.

To help meet the health needs of those living with disabilities, the authors of this article urged clinicians and researchers to reassess the lens they’re using in reference to people with disabilities and their inclusion in clinical trials. The COVID-19 vaccines are a case in point.

“There is mounting evidence that COVID-19 has had disproportionate effects on the disability community, which makes the inclusion of people with disabilities in clinical trials of COVID-19 vaccines critically important,” the authors wrote. In particular, they noted, data pertaining to people with disabilities in Covid vaccine trials are lacking.

It’s crucial for people with disabilities to be included in clinical research because their participation paves the way for better treatments that they specifically need.

The authors of the study published by Patient Preference and Adherence elaborated on this significance.

People with disabilities should be included in all scientifically appropriate intervention studies so that they can have access to safe and effective interventions that promote their long-term health and wellbeing.

 

Breaking down biases

Although practicing physicians may not have a say in research eligibility criteria, they can still do their part to help address biases toward patients with disabilities.

Another article published by Health Affairs looked at the results of a survey completed by 714 physicians.

Iezzoni LI, Rao SR, Ressalam J, et al. Physicians’ perceptions of people with disability and their health care. Health Affairs. 2021;40(2):297–306.

Of that group, only 40.7% felt “very confident” in their ability to provide care for patients with disabilities which equaled the care provided to patients without.

 

Only about half of the physicians welcomed patients with disabilities into their practice. For 18.1% of the surveyed physicians, it was clear that the healthcare system in the US often doesn’t treat patients with disabilities equitably.

Physicians who hold these views may contribute to the health disparities faced by patients with disabilities. To help address these possible biases, physicians can seek training that teaches about disability cultural competence and etiquette, according to Health Affairs.

They can also exercise empathy for patients with disabilities by learning about and providing other medical accommodations, which may include making house calls.

The inclusion of people with disabilities in clinical research is a policy issue that may ultimately require legislative action. But by interrogating their own possible biases and addressing them with actionable changes, clinicians can better serve their patients with disabilities.