Print Page

Disabled Commonly Excluded From Clinical Trial Eligibility

Published: 2022-10-03 - Updated: 2023-01-04
Author: Brigham and Women's Hospital - Contact: brighamandwomens.org
Peer-Reviewed: Yes
Journal Reference: DOI Link to the Study Paper
Related Papers: Latest Items - Full List

On This Page: Summary - Defining Clinical Trials - Main Article - About/Author

Synopsis: Despite constituting the largest minority group in the U.S. and expressing interest in participating in clinical trials, people with disabilities remain excluded. The research team found that protocol eligibility criteria frequently had language that could be used to exclude people with disabilities, including people who have psychiatric, substance use, cognitive or intellectual, or other impairments. The exclusion of people with disabilities from clinical research is counter to federal regulations and research guidelines, reduces access to the potential benefits of participation, limits study generalizability, and, without appropriate justification, is discriminatory.

Definition

Clinical Trials

Clinical trials are research studies performed on people that evaluate a medical, surgical, or behavioral intervention. They are the primary way that researchers determine if a new treatment, like a new drug, diet, or medical device, is safe and effective for people. Often a clinical trial is used to learn if a new treatment is more effective and/or has fewer harmful side effects than the standard treatment. People volunteer to participate in clinical trials to test medical interventions, including drugs, cells, and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, and preventive care.

Main Digest

Excluding People with Disabilities From Clinical Research: Eligibility Criteria Lack Clarity and Justification.

A new study led by investigators from Brigham and Women's Hospital, a founding member of the Mass General Brigham healthcare system, examined the relationship between study protocol eligibility criteria and the inappropriate exclusion of people with disabilities from clinical trials.

advertisement

The research team found that protocol eligibility criteria frequently had language that could be used to exclude people with disabilities, including those with psychiatric, substance use, cognitive or intellectual, or other impairments. Few studies included justifications for these exclusions or descriptions of offered or permitted accommodations. Results are published in the October issue of Health Affairs.

"While the underrepresentation of certain populations in clinical research has been recognized, and there have been concerted efforts to rectify this imbalance, our findings call attention to the need for greater recognition that people with disabilities as an underrepresented group," said study co-author Barbara Bierer, MD, Faculty Director of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. "The exclusion of people with disabilities from clinical research is counter to federal regulations and research guidelines, reduces access to the potential benefits of participation, limits study generalizability, and, without appropriate justification, is discriminatory."

Approximately 25 percent of adults in the U.S. have one or more cognitive, visual, hearing, mobility, developmental, or intellectual impairments. In addition, many people will develop a disability at some point in their life and/or may be caring for a loved one with a disability. But the exclusion of people with disabilities from clinical trials persists. In one example, the authors note that almost 90 percent of people with Down syndrome will develop Alzheimer's disease by age 55. Yet, few Alzheimer's trials specifically include this group of people.

To better document and understand the extent of exclusion concerning people with disabilities from clinical trials, the research team, led by Willyanne Plosky, DrPH, program manager of the Multi-Regional Clinical Trials Center, quantitatively and qualitatively analyzed the inclusion and exclusion criteria of 97 research interventions from ClinicalTrials.gov in the therapeutic areas of dementia, depression, diabetes, and lung cancer.

The researchers found that 85 percent of study protocols allowed broad investigator discretion regarding study eligibility. The phrasing of investigator discretion language was so expansive that many people with disabilities could be interpreted as ineligible.

The researchers also reported that most studies had eligibility criteria that excluded people with a range of disabilities, including:

Only 18 percent permitted people with disabilities to use accommodations, such as assistive devices, and few study protocols justified disability exclusions. The justifications were often ambiguous, open to subjective interpretation, or reflective of exclusions that would be unnecessary if proper accommodations were provided.

The study did have some limitations.

Only Phase 3 studies with posted protocols were analyzed, which might not represent the entire body of ongoing trials. In addition, the authors only coded inclusion, exclusion, accommodation, or justification information from the eligibility criteria section of the study protocols. Nevertheless, the investigators recommend greater forethought into study participant inclusion, adaptations for those included, and reasoning for those excluded.

They also advocate for more thoughtfully written justifications, which could open the door for oversight bodies such as Institutional Review Boards (IRBs) to review exclusion criteria for relevance/necessity and determine whether certain modifications can overcome exclusion. Lastly, they believe that eligibility criteria should be as inclusive as possible and only as restrictive as necessary.

"Given how prevalent disabilities are in the United States and globally, the public health and clinical implications of these exclusions are profound," said co-author Barbara Bierer, MD, and Faculty Director of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard.

DeCormier Plosky, Bierer, and colleagues at Harvard, Mass General Brigham, University of Utah, and Columbia are working to define specific issues around the underrepresentation of people with disabilities in clinical research to operationalize the next steps the research community can take to improve inclusion.

Disclosures:

Ne'eman reports consulting income within the past 12 months from the Service Employees International Union, Inclusa, CareSource, and the Department of Health and Human Services Office for Civil Rights. The data presented here were not collected as part of his duties for any of these entities, including the Department of Health and Human Services. They did not review the research, analysis, findings, and conclusions, nor do they necessarily represent their views. David Strauss received consulting income as an external adviser to the Takeda Pharmaceuticals Ethics Advisory Council.

Funding:

The study was partially supported by the National Institute of Mental Health, National Institutes of Health, under Award No. T32MH019733.

Paper Cited:

DeCormier Plosky, W. et al. "Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification." Health Affairs. DOI: 10.1377/hlthaff.2022.00520

Attribution/Source(s):

This peer reviewed article relating to our Clinical Trial Research section was selected for publishing by the editors of Disabled World due to its likely interest to our disability community readers. Though the content may have been edited for style, clarity, or length, the article "Disabled Commonly Excluded From Clinical Trial Eligibility" was originally written by Brigham and Women's Hospital, and published by Disabled-World.com on 2022-10-03 (Updated: 2023-01-04). Should you require further information or clarification, Brigham and Women's Hospital can be contacted at brighamandwomens.org. Disabled World makes no warranties or representations in connection therewith.

Share This Information To:
𝕏.com Facebook Reddit

Discover Related Topics:

advertisement


Information, Citing and Disclaimer

Disabled World is an independent disability community founded in 2004 to provide disability news and information to people with disabilities, seniors, their family and/or carers. See our homepage for informative reviews, exclusive stories and how-tos. You can connect with us on social media such as X.com and our Facebook page.


Permalink: <a href="https://www.disabled-world.com/medical/clinical-trials/excluded.php">Disabled Commonly Excluded From Clinical Trial Eligibility</a>


Cite This Page (APA): Brigham and Women's Hospital. (2022, October 3). Disabled Commonly Excluded From Clinical Trial Eligibility. Disabled World. Retrieved September 23, 2023 from www.disabled-world.com/medical/clinical-trials/excluded.php

Disabled World provides general information only. The materials presented are never meant to substitute for qualified professional medical care, nor should they be construed as such. Funding is derived from advertisements or referral programs. Any 3rd party offering or advertising does not constitute an endorsement.