It has been well understood by many in the bleeding disorders community that clinical trials are, historically, very limited and not fully representative of the actual disease populations. In an effort, to drill down on the barriers to representation, the American Society of Hematology (ASH) reached out to its robust global membership to get a better sense of the challenges associated with underrepresentation in classic hematology trials.
Their findings, “The Roadmap to Integrate Diversity, Equity, and Inclusion in Hematology Clinical Trials: An American Society of Hematology Initiative,” were published in the February edition of Blood Advances.
A baseline survey was disseminated to ASH members, with 191 responses from U.S. and international clinicians self-identifying as caring for individuals with classical hematologic diseases. The respondents, the majority of which (81%) were from North America, offered insight into the possible underlying causes of limited trial participation. Their feedback helped identify priority areas and structure five focus groups that encompassed various stakeholders including people living with hematologic diseases and their advocates; academicians; regulatory and government agencies; industry representatives; clinical research organizations and academic research organizations.
Eight primary barriers were identified across all groups. The authors suggested that addressing these specific barriers will ultimately enhance the development of future trials by featuring more diverse populations of people living with hematologic diseases. The eight barriers include: (1) harmonization of demographic terminology; (2) engagement of lived experience experts (LEEs) across the entire study timeline; (3) awareness of how implicit biases impede patient enrollment; (4) the need for institutional review boards to uphold the justice principle of clinical trial enrollment; (5) broadening of eligibility criteria; (6) decentralized trial design; (7) improving access to clinical trial information; and (8) increased community physician involvement.
“Addressing the barriers noted here extends beyond 1 key group or 1 trial, which is why partnering across LEEs, industry, regulators, academia, IRBs, and health care providers is essential.” stated the authors, in addition to recommending a few key action steps. “A holistic overview of the patient’s experience and disease demographics needs to be collected and discussed. Relevant LEEs and health care providers should be engaged early and often as research questions are crafted and clinical trials are designed.” The authors went on to further elaborate that “the insights from such engagement would include social determinants of health, reasons for mistrust, and health care access barriers. Rare classical hematology disease trials should seek to be inclusive through representative inclusion/exclusion criteria that are further evaluated for the impact of increased heterogeneity on the robustness of small data sets, end points that matter to patients, and ways to reduce participation burden on patients so that diversity can be achieved,” concluded the authors.
Read the full open access paper to learn more, including the demographic/geographic scope of the ASH initiative, plus a great deal more context and explanation behind the focus groups’ priority areas and proposed solutions.
Citation
Kuaban A, Croker AK, Keefer J, Valentino LA, Bierer BE, Boateng S, DiMichele D, Fogarty P, Gibson CM, Hood AM, Hubbard L, Isgrò A, Knobe K, Lake L, Martin I, Reid M, Roberts JC, Tomlinson W, Tunji-Ajayi L, Van Spall HGC, Voltz-Girolt C, Wheeler AP, Mast AE, Seremetis S. The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative. Blood Adv. 2025 Feb 25;9(4):687-695. doi: 10.1182/bloodadvances.2024013945. PMID: 39652409; PMCID: PMC11869854.
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