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. 2020 May 15;22(5):601-612.
doi: 10.1093/neuonc/noaa015.

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

Eudocia Q Lee  1   2 , Michael Weller  3 , Joohee Sul  4 , Stephen J Bagley  5 , Solmaz Sahebjam  6 , Martin van den Bent  7 , Manmeet Ahluwalia  8 , Jian L Campian  9 , Evanthia Galanis  10 , Mark R Gilbert  11 , Matthias Holdhoff  12 , Glenn J Lesser  13 , Frank S Lieberman  14 , Minesh P Mehta  15 , Marta Penas-Prado  11 , Karisa C Schreck  12 , Roy E Strowd  13 , Michael A Vogelbaum  6 , Tobias Walbert  16 , Susan M Chang  17 , L Burt Nabors  18 , Stuart Grossman  12 , David A Reardon  1   2 , Patrick Y Wen  1   2
Affiliations

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

Eudocia Q Lee et al. Neuro Oncol. .

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.

Keywords: clinical trials; eligibility; exclusion criteria; inclusion criteria; primary brain tumor.

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Figures

Fig. 1
Fig. 1
Reasons for ineligibility at screening for 153 patients with newly diagnosed or recurrent glioblastoma who signed consent for one of 6 principal investigator–initiated clinical trials at Dana-Farber Cancer Institute between March 2009 and February 2019.
See this image and copyright information in PMC

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