The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative
Abstract: 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...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-02-01
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| Series: | Blood Advances |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S247395292400644X |
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| author | Alice Kuaban Alysha K. Croker Jeffrey Keefer Leonard A. Valentino Barbara E. Bierer Stephen Boateng Donna DiMichele Patrick Fogarty C. Michael Gibson Anna M. Hood Lloryn Hubbard Antonella Isgrò Karin Knobe Leslie Lake Iman Martin Michel Reid Jonathan C. Roberts Wendy Tomlinson Lanre Tunji-Ajayi Harriette G.C. Van Spall Caroline Voltz-Girolt Allison P. Wheeler Alan E. Mast Stephanie Seremetis |
| author_facet | Alice Kuaban Alysha K. Croker Jeffrey Keefer Leonard A. Valentino Barbara E. Bierer Stephen Boateng Donna DiMichele Patrick Fogarty C. Michael Gibson Anna M. Hood Lloryn Hubbard Antonella Isgrò Karin Knobe Leslie Lake Iman Martin Michel Reid Jonathan C. Roberts Wendy Tomlinson Lanre Tunji-Ajayi Harriette G.C. Van Spall Caroline Voltz-Girolt Allison P. Wheeler Alan E. Mast Stephanie Seremetis |
| author_sort | Alice Kuaban |
| collection | DOAJ |
| description | Abstract: 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. |
| format | Article |
| id | doaj-art-f783afec465b489ca04361c891c877ab |
| institution | Kabale University |
| issn | 2473-9529 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Blood Advances |
| spelling | doaj-art-f783afec465b489ca04361c891c877ab2025-02-12T05:31:37ZengElsevierBlood Advances2473-95292025-02-0194687695The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiativeAlice Kuaban0Alysha K. Croker1Jeffrey Keefer2Leonard A. Valentino3Barbara E. Bierer4Stephen Boateng5Donna DiMichele6Patrick Fogarty7C. Michael Gibson8Anna M. Hood9Lloryn Hubbard10Antonella Isgrò11Karin Knobe12Leslie Lake13Iman Martin14Michel Reid15Jonathan C. Roberts16Wendy Tomlinson17Lanre Tunji-Ajayi18Harriette G.C. Van Spall19Caroline Voltz-Girolt20Allison P. Wheeler21Alan E. Mast22Stephanie Seremetis23Scientific Affairs Department, American Society of Hematology, Washington, DCHealth Canada, Ottawa, ON, CanadaIQVIA, Durham, NCNational Bleeding Disorders Foundation, New York, NYHarvard Medical School, Brigham and Women’s Hospital, Boston, MASickle Cell 101, San Jose, CADonna DiMichele Consulting, LLC, Washington, DCPfizer, Collegeville, PABaim Institute for Clinical Research, Boston, MAManchester Centre for Health Psychology, Division of Psychology and Mental Health, The University of Manchester, Manchester, United KingdomPPD, San Francisco, CAAIFA Italian Medicines Agency, Rome, ItalySanofi, Cambridge, MAInvus, New York, NYNational Institutes of Health, Bethesda, MDGlaxoSmithKline, Collegeville, PABleeding & Clotting Disorders Institute, Dills Family Foundation Center for Research at BCDI, Peoria, IL; Departments of Pediatrics and Medicine, University of Illinois College of Medicine at Peoria, Peoria, ILPPD, San Francisco, CAGlobal Action Network for Sickle Cell & Other Inherited Blood Disorders, Dover, DEBaim Institute for Clinical Research, Boston, MAEuropean Medicines Agency, Amsterdam, The NetherlandsDepartment of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TNThrombosis and Hemostasis Program, Versiti Blood Research Institute, Milwaukee, WI; Correspondence: Alan E. Mast, Thrombosis and Hemostasis Program, Versiti Blood Research Institute, P.O. Box 2178, Milwaukee, WI 53226;Novo Nordisk, Plainsboro, NJAbstract: 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.http://www.sciencedirect.com/science/article/pii/S247395292400644X |
| spellingShingle | Alice Kuaban Alysha K. Croker Jeffrey Keefer Leonard A. Valentino Barbara E. Bierer Stephen Boateng Donna DiMichele Patrick Fogarty C. Michael Gibson Anna M. Hood Lloryn Hubbard Antonella Isgrò Karin Knobe Leslie Lake Iman Martin Michel Reid Jonathan C. Roberts Wendy Tomlinson Lanre Tunji-Ajayi Harriette G.C. Van Spall Caroline Voltz-Girolt Allison P. Wheeler Alan E. Mast Stephanie Seremetis The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative Blood Advances |
| title | The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative |
| title_full | The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative |
| title_fullStr | The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative |
| title_full_unstemmed | The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative |
| title_short | The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative |
| title_sort | roadmap to integrate diversity equity and inclusion in hematology clinical trials an american society of hematology initiative |
| url | http://www.sciencedirect.com/science/article/pii/S247395292400644X |
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