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A Path of Progress: ASH Works to Increase Diversity in Clinical Trials

May 30, 2024

June 2024

The American Society of Hematology (ASH) has long been committed to combating inequities in hematology, supporting individuals from backgrounds underrepresented in medicine, and embracing diverse voices. As part of this mission, ASH has created several key resources and initiatives to ensure that hematology trials reflect the epidemiology of the disease and are inclusive of the population that will benefit from the therapeutic under investigation.

ASH Clinical News recently spoke to a member of ASH’s Committee on Scientific Affairs and Subcommittee on Clinical Trials, Alan E. Mast, MD, PhD, and a member of ASH’s Committee on Diversity, Equity, and Inclusion, Rayne H. Rouce, MD, about the Society’s major milestones toward improving inclusivity and access to clinical trials — especially for underrepresented populations — its ongoing progress, and what’s yet to come.

The importance of designing clinical trials that are reflective of real-world patient settings cannot be overstated, and there are significant, growing concerns that many trials are not designed in this way, meaning the outcomes generated can’t be applied to all patients. “We have to make sure our trials are not restricted to only certain subsets of affected populations, that our interventions in the real world have been tested in real-world settings,” said Dr. Rouce, who is also an associate professor in the Department of Pediatrics and associate director in the Office of Diversity, both at Baylor College of Medicine in Houston. “Our science is sophisticated and often uncovers subtle nuances and differences that must be adequately studied in all so all may benefit.”

Although ASH has always recognized the crucial need for clinical trials and their outcomes to be representative of diverse patient populations, the Society issued a policy statement in August 2021 that acknowledged this need and established new priorities to work toward. Clinical trials that are not diverse, the statement said, lead to health inequities in medical research and practice. Therefore, it is necessary for trial populations to reflect “the composition of a diverse society,” because this ultimately allows “researchers and physicians to better understand how diseases impact different populations, why they tend to disproportionately impact some populations over others, and (especially in the age of precision medicine) how treatments can be tailored to individual patients or a subset of patients.”1

Because “the medical community has learned that a one-size-fits-all approach is not ideal,” the statement called for the development of more “trials that will attract and enroll underrepresented patient populations.”1 ASH also pledged to “hold investigators of [National Institute of Health]- funded trials accountable when diverse groups are not enrolled” and to “collaborate with the [U.S. Food and Drug Administration] to provide substantial initiatives encouraging investigators to design clinical trials” that involve more representative populations.1

Shortly after the release of the policy statement, ASH conducted a series of surveys and focus groups — comprised of international clinical trials experts across academia, clinical and academic research organizations, patient advocacy groups, government agencies, and industry — “to identify current barriers and challenges to implementing diverse, representative clinical trials for rare classical hematologic disorders, such as hemophilia and sickle cell disease,” said Dr. Mast, who is also a senior investigator at Versiti Blood Research Institute in Milwaukee. The meetings identified several key issues for ASH and the broader hematology community to focus on, he explained, including “harmonization of demographic terminology, engagement of lived experience experts across the entire study timeline, [and] improved awareness of how implicit biases impede patient recruitment and enrollment.”

As a first step to addressing the concerns identified, ASH developed an indispensable resource for investigators that was launched at the 2023 ASH Annual Meeting: the ASH DEI Toolkit for Clinical Trial Sponsors. The toolkit, available online at hematology.org/diversity-equity-and-inclusion, includes a series of “key, actionable steps that should be undertaken starting at the initial stages of trial design through dissemination of study findings,” Dr. Mast said.

The steps outlined in the toolkit are intended to help investigators mitigate frequent barriers and challenges encountered when trying to design trials that are diverse, inclusive, and representative. The toolkit also provides checklists for formulating thoughtful research questions that engage the patient voice, creating a trial budget that will foster community engagement outreach efforts and recruitment of underrepresented patient populations, and collecting data, in addition to other helpful resources.

“[The toolkit] can serve as a starting point, a check-in step, or a review of individual, institutional, and industry health equity practices,” Dr. Rouce said.

Elements of the toolkit have also been incorporated into the curriculum of ASH’s Clinical Research Training Institute so applicants can reference it while drafting their research protocols.

In addition to the release of the toolkit, ASH is renewing its focus on specific issues related to promoting diversity in clinical trials, one of which is demographic data transparency. ASH requests that investigators share the demographic information (sex, gender, race, ethnicity, age, etc.) of enrolled subjects when submitting abstracts for ASH meetings, including the 2024 ASH Annual Meeting, and when submitting manuscripts for publication within ASH’s Blood Journals portfolio. If only some or none of the demographic information is available, investigators are encouraged to disclose data limitations in their submissions. Additionally, ASH is working to identify statisticians in hematology who can help their peers design more inclusive trials and is currently in the process of generating recommendations based off a recent survey.

Looking ahead, ASH’s Subcommittee on Clinical Trials has several additional activities and resources in development. “One of these initiatives has started with the launch of a needs assessment survey to gauge whether investigators will be interested in participating in a clinical trials learning ecosystem, a platform that would allow for peer-to-peer interaction, offer community engagement consultative services, and house resources relevant to clinical trial diversity,” Dr. Mast said, and encouraged ASH members who are clinical trialists to fill out the survey. Additionally, several ASH volunteers, who also worked on the clinical trials toolkit, are in the process of drafting two manuscripts to describe the ASH Roadmap to Improve DEI in Hematology Clinical Trials project, a detailed outline of the shortfalls in clinical trial design that ASH has identified and how the Society plans to address each one.

“ASH has truly been a leader in ensuring equity in hematology,” Dr. Rouce said of ASH’s progress to foster representative clinical trials. “We are a community of healers, of innovators, of educators, whether we work in a lab, see patients day to day, or champion guidelines and policy. It takes a diverse village to ensure our success, and the blueprint ASH has laid out allows every one of us to play a role in improving clinical outcomes in hematology. For all.”

Reference

  1. American Society of Hematology. ASH statement addressing diversity, equity, and inclusion in hematology research, training, and practice. August 11, 2021. Accessed April 29, 2024. https://www.hematology.org/Advocacy/policy-news-statements-testimony-and-correspondence/policy-statements/2021/ash-statement-addressing-diversity-equity-and-inclusion-in-hematology-research-practice-and-training.

 

 

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