@article{b79e8608a7db498ebe5fdaae8f6d91a3,
title = "Low clinical trial accrual of patients with myelodysplastic syndromes: Causes and potential solutions",
abstract = "Despite few effective therapies, only a small percentage of patients diagnosed with myelodysplastic syndromes (MDS) in the United States are enrolled in prospective, interventional clinical trials. MDS-specific barriers to trial accrual include a high frequency of elderly patients with comorbid conditions, atypical disease features and uncertainty regarding the diagnosis (because other nonclonal processes also can cause dysplasia and cytopenias), a history of another nonmyeloid neoplasm resulting in therapy-related MDS, rapid disease recurrence after allogeneic stem cell transplantation, and an arbitrary division between MDS and acute myeloid leukemia. In addition, barriers to accrual that are common to other oncology populations, such as difficulty traveling to clinical trial enrollment sites and narrow trial eligibility criteria, also prevent patients with MDS from enrolling in studies. Collectively these barriers must be assessed systematically, and creative solutions are needed to improve outcomes for this needy patient population.",
keywords = "adverse events, barriers to clinical trials, clinical trial enrollment, drug development, myelodysplastic syndromes, referral patterns",
author = "Steensma, {David P.} and Brunner, {Andrew M.} and DeZern, {Amy E.} and Guillermo Garcia-Manero and Komrokji, {Rami S.} and Odenike, {Olatoyosi S.} and Roboz, {Gail J.} and Savona, {Michael R.} and Stone, {Richard M.} and Sekeres, {Mikkael A.}",
note = "Funding Information: David P. Steensma has acted as a paid member of advisory boards of Celgene, Otsuka, and Novartis; as a member of the DMC services for Onconova and Takeda; and as a paid consultant for Janssen for work performed outside of the current study. Andrew M. Brunner has received clinical trial funding to his institution from Celgene, Takeda, and Novartis for work performed outside of the current study. Rami S. Komrokji has acted as a paid consultant and received honoraria from Celgene and acted as a member of the speakers{\textquoteright} bureau for and received honoraria from Novartis for work performed outside of the current study. Olatoyosi Odenike has received honoraria from AbbVie Pharmaceuticals; acted as a paid member of the advisory boards of and as a consultant for Pfizer, Dava Oncology, Incyte Pharmaceuticals, and Jazz Pharmaceuticals; acted as a member of the advisory boards of, acted as a paid consultant for, and received research funding from Celgene and CTI/Baxalta; and has received research funding from Oncotherapy Science, Agios Pharmaceuticals, NS Pharma, Janssen Research and Development, Astex Pharmaceuticals, and Gilead Sciences for work performed outside of the current study. Michael R. Savona has received personal fees from Amgen; received a grant from Astex Pharmaceuticals; has a licensing agreement with Boehringer-Ingelheim; has acted as a member of the data safety monitoring board and as an advisor for Celgene, has acted as a member of the data safety monitoring board for Gilead; has acted as an advisor and has equity in Karyopharm; and has received research funding from and acted in an advisory role for Sunesis Pharmaceuticals, Takeda, and TG Therapeutics for work performed outside of the current study. Richard M. Stone has acted as a paid consultant and as an ad hoc for AbbVie Pharmaceuticals; has acted as a member of the scientific advisory board for Actinium; has acted as a paid consultant for and received research funding from Agios, Arog Pharmaceuticals, and Novartis; has acted as a member of the data safety monitoring board for Argenx; has acted as a paid consultant and member of the data safety monitoring board and steering committee for Celgene; and has acted as a paid consultant for Amgen, Astellas, Cornerstone, Fujifilm, Jazz Pharmaceuticals, Merck, Ono, Orsenix, Pfizer, and Sumiotomo for work performed outside of the current study. Mikkael A. Sekeres has acted a paid member of the advisory boards for Celgene and Opsona Therapeutics for work performed outside of the current study. Publisher Copyright: {\textcopyright} 2018 American Cancer Society",
year = "2018",
month = dec,
day = "15",
doi = "10.1002/cncr.31769",
language = "English (US)",
volume = "124",
pages = "4601--4609",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",
number = "24",
}