Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients

Eudocia Q. Lee, Eudocia Q. Lee, Michael Weller, Joohee Sul, Stephen J. Bagley, Solmaz Sahebjam, Martin Van Den Bent, Manmeet Ahluwalia, Jian L. Campian, Evanthia Galanis, Mark R. Gilbert, Matthias Holdhoff, Glenn J. Lesser, Frank S. Lieberman, Minesh P. Mehta, Marta Penas-Prado, Karisa C. Schreck, Roy E. Strowd, Michael A. Vogelbaum, Tobias WalbertSusan M. Chang, L. Burt Nabors, Stuart Grossman, David A. Reardon, David A. Reardon, Patrick Y. Wen, Patrick Y. Wen

Research output: Contribution to journalReview articlepeer-review

4 Scopus citations

Abstract

Building on an initiative to enhance clinical trial participation involving the Society for Neuro-Oncology, the Response Assessment in Neuro-Oncology Working Group, patient advocacy groups, clinical trial cooperative groups, and other partners, we evaluate the impact of eligibility criteria and trial conduct on neuro-oncology clinical trial participation. Clinical trials often carry forward eligibility criteria from prior studies that may be overly restrictive and unnecessary and needlessly limit patient accrual. Inclusion and exclusion criteria should be evaluated based on the goals and design of the study and whether they impact patient safety and/or treatment efficacy. In addition, we evaluate clinical trial conduct as a barrier to accrual and discuss strategies to minimize such barriers for neuro-oncology trials.

Original languageEnglish (US)
Pages (from-to)601-612
Number of pages12
JournalNeuro-oncology
Volume22
Issue number5
DOIs
StatePublished - May 15 2020

Keywords

  • clinical trials
  • eligibility
  • exclusion criteria
  • inclusion criteria
  • primary brain tumor

ASJC Scopus subject areas

  • Oncology
  • Clinical Neurology
  • Cancer Research

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