The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative

被引：0
|
作者：
Kuaban, Alice [1 ]
Croker, Alysha K. [2 ]
Keefer, Jeffrey [3 ]
Valentino, Leonard A. [4 ]
Bierer, Barbara E. [5 ]
Boateng, Stephen [6 ]
Dimichele, Donna [7 ]
Fogarty, Patrick [8 ]
Gibson, C. Michael [9 ]
Hood, Anna M. [10 ]
Hubbard, Lloryn [11 ]
Isgro, Antonella [12 ]
Knobe, Karin [13 ]
Lake, Leslie [14 ]
Martin, Iman [15 ]
Reid, Michel [16 ]
Roberts, Jonathan C. [17 ,18 ,19 ]
Tomlinson, Wendy [11 ]
Tunji-Ajayi, Lanre [20 ]
Van Spall, Harriette G. C. [9 ]
Voltz-Girolt, Caroline [21 ]
Wheeler, Allison P. [22 ]
Mast, Alan E. [23 ]
Seremetis, Stephanie [24 ]
机构：
[1] Amer Soc Hematol, Sci Affairs Dept, Washington, DC USA
[2] Hlth Canada, Ottawa, ON, Canada
[3] IQVIA, Durham, NC USA
[4] Natl Bleeding Disorders Fdn, New York, NY USA
[5] Harvard Med Sch, Brigham & Womens Hosp, Boston, MA USA
[6] Sickle Cell 101, San Jose, CA USA
[7] Donna DiMichele Consulting LLC, Washington, DC USA
[8] Pfizer, Collegeville, PA USA
[9] Baim Inst Clin Res, Boston, MA USA
[10] Univ Manchester, Manchester Ctr Hlth Psychol, Div Psychol & Mental Hlth, Manchester, England
[11] PPD, San Francisco, CA USA
[12] AIFA Italian Med Agcy, Rome, Italy
[13] Sanofi, Cambridge, MA USA
[14] Invus, New York, NY USA
[15] NIH, Bethesda, MD USA
[16] GlaxoSmithKline, Collegeville, PA USA
[17] Dills Family Fdn Ctr Res BCDI, Bleeding & Clotting Disorders Inst, Peoria, IL USA
[18] Univ Illinois, Coll Med Peoria, Dept Pediat, Peoria, IL USA
[19] Univ Illinois, Coll Med Peoria, Dept Med, Peoria, IL USA
[20] Global Act Network Sickle Cell & Other Inherited, Dover, DE USA
[21] European Med Agcy, Amsterdam, Netherlands
[22] Vanderbilt Univ, Med Ctr, Dept Pathol Microbiol & Immunol, Nashville, TN USA
[23] Versiti Blood Res Inst, Thrombosis & Hemostasis Program, POB 2178, Milwaukee, WI 53226 USA
[24] Novo Nordisk, Plainsboro, NJ USA
来源：
BLOOD ADVANCES | 2025年 / 9卷 / 04期
关键词：
D O I：
10.1182/bloodadvances.2024013945
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
Clinical trial design for classical hematologic diseases is difficult because samples sizes are often small and not representative of the disease population. The American Society of Hematology initiated a roadmap project to identify barriers and make progress to integrate diversity, equity, and inclusion into trial design and conduct. Focus groups of international experts from across the clinical trial ecosystem were conducted. Eight issues identified include (1) harmonization of demographic terminology; (2) engagement of lived experience experts 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. By addressing these issues, the hematology community can promote accessible and inclusive trials that will further inform research, clinical decision-making, and care for patients.
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页码：687 / 695
页数：9
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