{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T10:28:43Z","timestamp":1789122523902,"version":"build-2803163510"},"reference-count":39,"publisher":"American Society of Hematology","issue":"13","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,3,27]]},"abstract":"<jats:sec>\n                    <jats:title>Abstract<\/jats:title>\n                    <jats:p>Excessively restrictive inclusion and exclusion criteria in clinical trials are one of many barriers to clinical trial enrollment for patients with myelodysplastic syndromes\/neoplasms (MDSs). Many organizations are developing efforts to increase clinical trial eligibility; yet, several recent publications focused on patients with MDS suggest that many patients with this disease may be excluded from clinical trials unnecessarily. Clinical trial eligibility should reflect the phase of the study and risks of the agent being studied. Phase 3 trials should be less restrictive than early-phase trials to represent the real-world population as closely as possible. We hypothesize that many clinical trials, particularly phase 3 trials, have unnecessarily restrictive eligibility criteria. This study aims to evaluate the most common eligibility criteria according to phase of trial and to determine whether criteria correspond with drug safety signals. We identified MDS clinical trials registered on ClinicalTrials.gov from 1 January 2000 to 1 September 2023 and analyzed the eligibility criteria of 191 therapeutic MDS trials. We found that categorical inclusion and exclusion criteria are remarkably similar in representation across trial phases. Additionally, only 13% of trials are concordant with drug safety signals, suggesting that the eligibility criteria are often arbitrary. On behalf of the icMDS (International Consortium for Myelodysplastic Syndromes), an association of international MDS experts, we provide a position statement on restrictive eligibility criteria for MDS clinical trials that should be avoided with the aim of removing barriers to clinical trial enrollment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1182\/blood.2023023717","type":"journal-article","created":{"date-parts":[[2025,3,27]],"date-time":"2025-03-27T14:49:14Z","timestamp":1743086954000},"page":"1369-1381","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":11,"title":["Reducing clinical trial eligibility barriers for patients with MDS: an icMDS position statement"],"prefix":"10.1182","volume":"145","author":[{"given":"Uma","family":"Borate","sequence":"first","affiliation":[{"name":"1Division of Hematology, The Ohio State University Comprehensive Cancer Center\/James Cancer Hospital, The Ohio State University, Columbus, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-2913-9183","authenticated-orcid":false,"given":"Kelly","family":"Pugh","sequence":"additional","affiliation":[{"name":"1Division of Hematology, The Ohio State University Comprehensive Cancer Center\/James Cancer Hospital, The Ohio State University, Columbus, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allyson","family":"Waller","sequence":"additional","affiliation":[{"name":"1Division of Hematology, The Ohio State University Comprehensive Cancer Center\/James Cancer Hospital, The Ohio State University, Columbus, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9477-4581","authenticated-orcid":false,"given":"Rina Li","family":"Welkie","sequence":"additional","affiliation":[{"name":"1Division of Hematology, The Ohio State University Comprehensive Cancer Center\/James Cancer Hospital, The Ohio State University, Columbus, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Huang","sequence":"additional","affiliation":[{"name":"1Division of Hematology, The Ohio State University Comprehensive Cancer Center\/James Cancer Hospital, The Ohio State University, Columbus, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan Philipp","family":"Bewersdorf","sequence":"additional","affiliation":[{"name":"2Section of Hematology, Department of Internal Medicine, Yale University School of Medicine and Yale Cancer Center, New Haven, CT"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maximilian","family":"Stahl","sequence":"additional","affiliation":[{"name":"3Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy E.","family":"DeZern","sequence":"additional","affiliation":[{"name":"4Division of Hematology 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Centre, Royal Melbourne Hospital, Walter and Eliza Hall Institute of Medical Research, The University of Melbourne, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rena J.","family":"Buckstein","sequence":"additional","affiliation":[{"name":"8Department of Medical Oncology\/Hematology, Sunnybrook Health Sciences Centre, Toronto, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0384-3658","authenticated-orcid":false,"given":"Gail J.","family":"Roboz","sequence":"additional","affiliation":[{"name":"9Division of Hematology and Medical Oncology, Weill Cornell Medical College and New York Presbyterian Hospital, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael R.","family":"Savona","sequence":"additional","affiliation":[{"name":"10Division of Hematology\/Oncology, Department of Medicine, Vanderbilt University Medical Center, Nashville, 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Lee Moffitt Cancer Center, Tampa, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6189-8067","authenticated-orcid":false,"given":"Christopher S.","family":"Hourigan","sequence":"additional","affiliation":[{"name":"15Fralin Biomedical Research Institute, Virginia Tech Fralin Biomedical Research Institute Cancer Research Center, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6915-5970","authenticated-orcid":false,"given":"Matteo Giovanni","family":"Della Porta","sequence":"additional","affiliation":[{"name":"16Department of Biomedical Sciences, IRCCS Humanitas Clinical and Research Center and Humanitas University, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Nimer","sequence":"additional","affiliation":[{"name":"6Division of Hematology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4091-1699","authenticated-orcid":false,"given":"Richard F.","family":"Little","sequence":"additional","affiliation":[{"name":"17National Cancer Institute, Cancer Therapy Evaluation Program, Rockville, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5439-2172","authenticated-orcid":false,"given":"Valeria","family":"Santini","sequence":"additional","affiliation":[{"name":"18Myelodysplastic Syndromes Unit, Hematology, Azienda Ospedaliera Universitaria Careggi, University of Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabio","family":"Efficace","sequence":"additional","affiliation":[{"name":"19Italian Group for Adult Hematologic Diseases, Health Outcomes Research Unit, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4407-6325","authenticated-orcid":false,"given":"Justin","family":"Taylor","sequence":"additional","affiliation":[{"name":"6Division of Hematology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillermo","family":"Garcia-Manero","sequence":"additional","affiliation":[{"name":"20Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olatoyosi","family":"Odenike","sequence":"additional","affiliation":[{"name":"21Section of Hematology\/Oncology, Leukemia Program, University of Chicago Medicine and University of Chicago Comprehensive Cancer Center, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5182-3870","authenticated-orcid":false,"given":"Tae Kon","family":"Kim","sequence":"additional","affiliation":[{"name":"10Division of Hematology\/Oncology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2737-9810","authenticated-orcid":false,"given":"Stephanie","family":"Halene","sequence":"additional","affiliation":[{"name":"2Section of Hematology, Department of Internal Medicine, Yale University School of Medicine and Yale Cancer Center, New Haven, CT"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1876-5269","authenticated-orcid":false,"given":"Rami S.","family":"Komrokji","sequence":"additional","affiliation":[{"name":"14Department of Malignant Hematology, H. 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