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A pragmatic patient-reported outcome strategy for rare disease clinical trials: application of the EORTC item library to myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia

Crossref DOI link: https://doi.org/10.1186/s41687-019-0123-4

Published Online: 2019-06-19

Published Print: 2019-12

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Bell, Jill A.

Galaznik, Aaron

Pompilus, Farrah

Strzok, Sara

Bejar, Rafael

Scipione, Fatima

Fram, Robert J.

Faller, Douglas V.

Cano, Stefan

Marquis, Patrick
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Article History

Received: 31 January 2019

Accepted: 5 May 2019

First Online: 19 June 2019

Ethics approval and consent to participate

: The study was reviewed and approved by Quorum Review: Protocol #TAK1068; Reference #32211/1. All patients provided written consent to participate.

: All patients provided written consent to have the results of this study published in medical journals. The consent form informed patients that no personal information will be revealed.

: The study was funded by Millennium Pharmaceuticals, Inc., Cambridge, MA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. JB, AG, FS, RF, and DF are employees of and have ownership interest in Takeda Pharmaceuticals. FP, SS, SC, and PM are employees of Modus Outcomes, which received payment from Takeda Pharmaceuticals to conduct this research. RB is a clinical consultant and was compensated by Modus Outcomes to provide feedback on the results of this research.

: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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