Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients. Issue 5 (24th January 2020)

• Record Type: Journal Article
• Authors: Lee, Eudocia Q; Weller, Michael; Sul, Joohee; Bagley, Stephen J; Sahebjam, Solmaz; van den Bent, Martin; Ahluwalia, Manmeet; Campian, Jian L; Galanis, Evanthia; Gilbert, Mark R; Holdhoff, Matthias; Lesser, Glenn J; Lieberman, Frank S; Mehta, Minesh P; Penas-Prado, Marta; Schreck, Karisa C; Strowd, Roy E; Vogelbaum, Michael A; Walbert, Tobias; Chang, Susan M; Nabors, L Burt; Grossman, Stuart; Reardon, David A; Wen, Patrick Y
• Is Part Of: Neuro-oncology. Volume 22:Issue 5(2020)
• Page Start: 601
• Page End: 612
• Publication Date: 2020-01-24
• Subjects: clinical trials -- primary brain tumor -- eligibility -- inclusion criteria -- exclusion criteria; Brain Neoplasms -- Periodicals; Brain -- Tumors -- Periodicals; Brain -- Cancer -- Periodicals; Nervous system -- Cancer -- Periodicals; 616.99481
• DOI: 10.1093/neuonc/noaa015
• Languages: English
• ISSNs: 1522-8517

Abstract

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.