Low clinical trial accrual of patients with myelodysplastic syndromes: Causes and potential solutions

David P. Steensma, Andrew M. Brunner, Amy E. DeZern, Guillermo Garcia-Manero, Rami S. Komrokji, Olatoyosi S. Odenike, Gail J. Roboz, Michael R. Savona, Richard M. Stone, Mikkael A. Sekeres

Research output: Contribution to journalComment/debatepeer-review

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.

Original languageEnglish (US)
Pages (from-to)4601-4609
Number of pages9
JournalCancer
Volume124
Issue number24
DOIs
StatePublished - Dec 15 2018

Keywords

  • adverse events
  • barriers to clinical trials
  • clinical trial enrollment
  • drug development
  • myelodysplastic syndromes
  • referral patterns

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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