Despite regulatory guidance, disability status is frequently unreported or overlooked in trial design.
A study recently published in the Journal of the American Heart Association found low representation of individuals with disabilities in cardiac randomized clinical trials (RCTs) in the United States. The investigation revealed that disability status was frequently not accounted for in the study design and implementation process.
“Cardiovascular disease is associated with significant morbidity and mortality, ultimately leading to both transitory as well as permanent disability,” the authors wrote.1
According to the Centers for Disease Control and Prevention, a disability is any condition of the body or mind that makes it more difficult for the affected person to perform certain activities and interact with the world around them, ultimately leading to a debilitating impact on their quality of life.2
For the study, the authors conducted a search of ClinicalTrials.gov for the 20 most recently completed interventional studies with completed results and associated peer‐reviewed articles. Enrollment was limited to the United States, in which coronary artery disease, hypertension, atrial fibrillation, and diabetes were the main conditions studied. This search yielded 80 RCTs, encompassing a total of 452,149 participants. The study then reviewed each RCT’s published article as well as publicly available study protocols to determine the frequency of disability reporting by exclusion criteria.1
Despite the substantial impact of cardiovascular disease on disability, the findings reveal a notable underrepresentation of people with disabilities in these trials. Disability status is frequently unreported or overlooked in trial design, with 38% of trials excluding individuals with disabilities. The most excluded subtype is cognition/psychiatric disabilities. Moreover, only 8% of trials report participant disabilities at baseline, and atrial fibrillation trials notably omit this information.1
“Recent literature has highlighted racial, ethnic, and sex disparities in cardiovascular clinical trials; however, reporting of disabilities has never been systematically assessed in cardiovascular RCTs,” the authors wrote. “Although cardiovascular disease is the second‐leading cause of disability worldwide and a leading cause for people aged >50 years, our findings indicate that the majority of cardiovascular clinical trials do not even report disability status for patients at baseline or in their study protocols, let alone include them for participation.”
The article brings attention to the Code of Federal Regulations Title 21, Part 56 (21CFR56), which states that trial enrollees selected from vulnerable populations, including those with physical and mental disabilities, must be provided protections to safeguard health and welfare during clinical trials.3 The authors follow by stating, “However, this does not preclude them from participating in clinical trials and should not prevent the reporting of disabilities in a transparent and holistic manner. Increased reporting and transparency on disabilities may enable researchers and clinicians to better advocate for this vulnerable population, especially if aligned with Centers for Disease Control and Prevention disabilities reporting guidelines.”1
The study calls for increased transparency in reporting disability status, suggesting adherence to Centers for Disease Control and Prevention-defined categories to enhance inclusivity. As cardiovascular disease ranks high in global disability, addressing these limitations is crucial for promoting health equity and ensuring the applicability of trial findings across diverse patient populations, the study authors concluded. They advocate for further research involving individuals with disabilities to enhance their engagement in clinical trials.
References
- Lan, R. H., Rice, E. N., Nunes, J. C., Shah, R., Igwe, J.-K., Clark, K., Periyakoil, V. S., Chen, J. H., Lin, B., Awad, C., Idris, M., Cruz, E. R., Lewis, E. F., Brown Johnson, C., & Wang, P. J. (2023). Disability Reporting in United States Cardiovascular Clinical Trials. Journal of the American Heart Association, 12(e029726). https://doi.org/10.1161/JAHA.123.029726
- Okoro CA, Hollis ND, Cyrus AC, Griffin‐Blake S. Prevalence of disabilities and health care access by disability status and type among adults—United States, 2016. MMWR Morb Mortal Wkly Rep. 2019; 67:882–887. doi: 10.15585/MMWR.MM6732A3
- Institutional review boards. 21 CFR Part 56 (1981).