Improvements in Enhancing Clinical Trial Diversity
Diversity in clinical trials has been a topic of interest at Diverse Health Hub (DHH). Increasing diversity in clinical trials helps investigators to further improve and refine treatments for underrepresented patient groups. We will continue analyzing efforts to address racial and ethnic disparities in health care to gauge progress in these areas. Here’s a look at U.S. efforts for improvements in enhancing clinical trial diversity.
Clinical Trial Disparities and Mistrust
In a previous interview with Dr. Gary Puckrein, President of the National Minority Quality Forum, he shared some information that provides context about some of clinical trial history in the U.S. “Back in the 1990s we didn’t recruit women into clinical trials, and so there was a big struggle to make sure that clinical trials were diverse by gender. Back then the assumption was if you have a bunch of men in the trial, women would react the same way that men do to the medications or the disease pathology would be the same and so, why would you need to have women in trials?”
And Dr. Puckrein provided information about what created the history of mistrust in the Black community. “In the African-American community, there are fears that came out of the Tuskegee experiment where therapy was withheld from African-Americans who were suffering from syphilis for no particular reason and it has an awful impact on their lives and so, that’s a deep scar in the African-American community about participating in clinical trials.”
Prioritization of Clinical Trial Diversity
As racial and ethnic disparities in health care continue, the Biden administration has prioritized a variety of ways to increase diversity. Some of the methods the administration has used is diverse representation in President Biden’s Cabinet members and prioritizing efforts addressing racial and ethnic disparities in health care. The US Food and Drug Administration (FDA) has advised clinical trial sponsors to include a plan to specifically improve diversity (Race and Ethnicity Diversity Plan) in their clinical trial design proposals that go to FDA reviewers. The FDA lists historical mistrust of the clinical research system, health care access inequities, and racism, as reasons for the lack of underrepresented racial and ethnic populations in clinical research. Additional information about the guidance can be found in Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.
The FDA has communicated a framework that aims to make clinical trial sponsors take more deliberate steps towards achieving research diversity in their studies. The framework outlines five recommended elements for inclusion in clinical trial design proposals including:
Description of available data on the pathophysiology of the disease or condition in underrepresented racial and ethnic populations. It should also discuss any variations across racial and ethnic populations in the applications or uses of available prevention, screening, or diagnostic strategies and treatments for the disease or condition.
Description of the planned trials for the program. This section of the Plan would include outlines of the proposed studies and how the inclusion of underrepresented racial and ethnic populations would be addressed.’
Definition of enrollment goals for underrepresented racial and ethnic participants based on the epidemiology of the disease and a priori information that may impact outcomes across racial and ethnic groups. In some cases, greater than proportional enrollment of certain populations may be needed to study potential important differences. The Plan should further detail the specific plan of action and strategies to enroll and retain diverse participants throughout the trial, including site selection and access considerations, community engagement efforts, and plans to reduce access burdens due to the design and conduct of the study.
As the Plan is updated and the study proceeds, sponsors will also discuss the status of the enrollment goals with FDA. If the enrollment goals are not met, sponsors may be expected to discuss a plan and justification for collecting relevant data in the post-marketing setting.
Outline the sponsor’s proposed approach to collecting data to explore the potential differences in the drug’s safety and effectiveness associated with racial and ethnic backgrounds throughout the product’s life cycle, and plans for pediatric studies that include racial and ethnically diverse populations as part of the medical product development program.
The FDA has issued guidelines to improve clinical trial diversity. Some of the recommendations include:
Ensuring clinical trial eligibility criteria are representative of diverse patient groups
Developing specific eligibility criteria for each trial and eliminating restrictive criteria
Involving enough patients from all racial and ethnic groups, sexes, and age groups
Using mobile medical professionals in clinical trials
Considering digital health technology tools
Promoting awareness about financial reimbursements
Holding clinical trials in areas with higher BIPOC representation
Providing clinical trial documents in multiple languages and literacy levels
Holding recruitment events on nights and weekends in non-clinical locations like churches, barber shops, community centers, and sporting events
Discussing potential trials with patient advocacy groups and medical associations
Engaging communities through disease registries, medical societies, and focus groups
As more of these recommendations are implemented in clinical trial processes and designs, clinical trial data should start to show more signs of improvement. We’re here to provide educational resources to increase patient knowledge and confidence about clinical trials.
Do you or someone you know feel apprehensive about participating in clinical trials? Learn more about the importance of participation: Diversity in Clinical Trials Benefits Everyone.
If you have an experience to share of when you experienced a health disparity, contact us at DHH. We collect experiences to expose and hopefully prevent them from happening in the future, and to create a space of healing for the individual.
We will continue to provide more clinical trial diversity updates. Stay tuned for reports about advancements and improving cancer research and treatments for underserved patients.
Sources
Thomas Sullivan. FDA Issues Draft Guidance Focused on Clinical Trial Diversity. Policy & Medicine website. Accessed June 21, 2022. https://www.policymed.com/2022/06/fda-issues-draft-guidance-focused-on-clinical-trial-diversity.html
Jamie Gamerman, J.D. Enhancing Diversity of Clinical Trial Populations: An Overview of the FDA’s Guidance on Clinical Trial Diversity. US Food & Drug Administration (FDA). Accessed June 21, 2022.
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