Uma Borate: Reducing Clinical Trial Eligibility Barriers for MDS
Uma Borate, Acute Leukemia Clinical Section Head and Research Director at James Cancer Hospital shared a post on X:
“Publication alert on behalf of the International Consortium for MDS (icMDS) in Blood Journal, Reducing Clinical Trial Eligibility Barriers for MDS: An icMDS Position Statement.
This paper demonstrates how eligibility criteria for LR and HR MDS often do not vary across trial phases and don’t reflect known drug safety signals. We analyzed therapeutic MDS trials over 2 decades and found only a minority prioritized eligibility criteria in concordance with known drug safety signals suggesting many of these criteria may be arbitrary.
This was rigorously done across all trial phases with validation by a hematology clinical pharmacist who cross-referenced drug IBs and published safety data. Lastly, a Delphi process by the International Consortium for MDS (icMDS) consortium then provided recommendations on how to streamline eligibility across various MDS trials to maximize real-world patient enrollment.
We hope this will help future MDS therapeutic development (no new approvals in HR MDS over a decade now) and enable more real-world, diverse patient enrollment in our MDS studies.”
Authors: Uma Borate, Kelly Pugh, Allyson Waller, Rina Li Welkie, Ying Huang, Jan Philipp Bewersdorf, Maximilian Stahl, Amy E DeZern, Uwe Platzbecker, Mikkael A Sekeres, Andrew H Wei, Rena J Buckstein, Gail J Roboz, Michael R Savona, Sanam Loghavi, Robert P Hasserjian, Pierre Fenaux, David A Sallman, Christopher S Hourigan, Matteo Giovanni Della Porta, Stephen Nimer, Richard F Little,Valeria Santini, Fabio Efficace, Justin Taylor, Guillermo Garcia-Manero, Olatoyosi Odenike, Tae Kon Kim, Stephanie Halene, Rami S Komrokji, Elizabeth A Griffiths, Peter L Greenberg, Mina L Xu, Zhuoer Xie, Rafael Bejar, Guillermo F Sanz, Mrinal M Patnaik, Maria Figueroa, Hetty E Carraway, Omar Abdel-Wahab, Daniel Starczynowski, Eric Padron, Jacqueline Boultwood, Steven Gore, Naval G Daver, Jane E Churpek, Ravindra Majeti, John M Bennett, Alan F List, Andrew M Brunner and Amer M Zeidan
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