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Surveys and focus groups find little integration of DEI principles, yield actionable recommendations

(SAN DIEGO, Dec. 9, 2024) — The ÎÚÑ»´«Ã½ (ASH) leveraged its convening power to launch an initiative for identifying barriers to diversity, equity, and inclusion (DEI) implementation in clinical trials, as well as a survey to assess the current strategies investigators use to implement DEI principles in their research. Details on the two projects were presented at the 66th ASH Annual Meeting and Exposition.

Though the importance of recruiting representative cohorts in clinical trials is increasingly recognized, “there remains a lack of equitable enrollment,” said Alice Kuaban, MS, director of scientific affairs at ASH, and a facilitator of ASH’s DEI in Clinical Trials Working Group. “This is an equity and safety issue. Characteristics such as race, ethnicity, and sex can impact the way people respond to therapies. Patients should be able to know, when they receive a therapy, that it works on people like them.”

Ms. Kuaban and several ASH members, including Alan E. Mast, MD, PhD, of Versiti Blood Research Institute in Milwaukee, and Stephanie V. Seremetis, MD, of Novo Nordisk in Plainsboro, New Jersey, conducted of DEI in classical hematology clinical trials – research on non-cancerous blood disorders, many of which are considered rare – to determine barriers to integrating DEI into clinical trials and actionable recommendations for navigating them.

“Diseases in classical hematology have especially been overlooked in terms of DEI, although they are particularly good examples of those in which it’s important to recruit a diverse array of patients,” said Dr. Seremetis. “Much of what we learned from looking at classical hematology diseases as a starting point can be generalized to the rest of hematology and other diseases.”

The team surveyed 191 ASH members who treat patients with classical hematologic diseases and drew upon their responses to conduct five international focus group discussions of 10 participants each, including leaders in academia, industry, government agencies, and clinical and academic research organizations, as well as lived experience experts – individuals with a classical hematologic disease. Additionally, the team surveyed 900 ASH members who devoted more than 75% of their time to clinical practice and care for individuals with classical hematologic diseases to help inform final recommendations.

Ms. Kuaban and her team identified eight key barriers and subsequent recommendations that can help build more accessible and equitable clinical trials, including:

1. The harmonization of demographic terminology and data collection
2. Engagement of lived experience experts from study start to the dissemination of results
3. Improved awareness of how implicit biases impede patient enrollment
4. The need for the Institutional Review Board (IRB) to uphold the justice principle of clinical trial enrollment
5. Broadening of eligibility criteria so fewer people are excluded from trial participation
6. Expanding access using a decentralized trial design
7. Improving access to clinical trial information
8. Increasing involvement of community physicians in the clinical trial ecosystem

“Engaging lived experience experts is especially key,” said Ms. Kuaban. “Patients want to be heard. They’re the experts on their own diseases and have a unique perspective to offer that could inform study design.”

In an adjacent ASH initiative, Hope Wilson, MD, assistant professor in the division of pediatric hematology/oncology at the University of Alabama’s Birmingham Heersink School of Medicine, led an to assess the tools and strategies investigators are currently using to integrate DEI into clinical trials.

The survey was developed using QuestionPro software and distributed to ASH members, individuals on the “This Week in Blood” email list, and 2023 ASH Annual Meeting attendees or presenting authors. In total, 774 recipients responded to the survey, with 502 recipients completing the survey in full.

Responses to the survey pointed to significant gaps in training on incorporating DEI principles into clinical trials. Seventy-four percent of respondents reported no such training, and many respondents indicated that they did not consistently use or did not at all use a DEI tool or tactic in their clinical research. Only 19% reported engaging patients in the design, review, or revision of a trial.

Together, the findings from these two initiatives elucidate barriers to integrating DEI principles into clinical trials and propose actionable strategies for increasing and improving representation in study cohorts. To further build upon this work, the researchers are exploring the development of a learning ecosystem that will serve as an educational platform to help investigators develop trials that are more likely to recruit diverse patient populations.

“At the end of the day, increasing study cohort diversity helps foster research because there are unique lessons to be learned from different cohorts that can advance future studies down the line,” said Ms. Kuaban. “ASH is drawing upon the results of these exercises to take steps to address these issues. We’ve already made significant progress in doing so and look forward to refining and expanding our work in this area.”

Learn more about ASH’s work to promote DEI principles in clinical trials, including the Society’s DEI Toolkit for Clinical Trial Sponsors, at www.hematology.org/diversity-equity-and-inclusion.

The ÎÚÑ»´«Ã½ (ASH) (hematology.org) is the world’s largest professional society of hematologists dedicated to furthering the understanding, diagnosis, treatment, and prevention of disorders affecting the blood. Since 1958, the Society has led the development of hematology as a discipline by promoting research, patient care, education, training, and advocacy in hematology.

The Blood journals () are the premier source for basic, translational, and clinical hematological research. The Blood journals publish more peer-reviewed hematology research than any other academic journals worldwide.

Claire Whetzel, 202-629-5085
[email protected]