Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients
Eudocia Q. Lee, Michael Weller, Joohee Sul, Stephen Bagley, Solmaz Sahebjam, Martin J. van den Bent, Manmeet S. Ahluwalia, Jian Campian, Evanthia Galanis, Mark R. Gilbert, Matthias Holdhoff, Glenn J. Lesser, Frank S. Lieberman, Minesh P. Mehta, Marta Peñas-Prado, Karisa C. Schreck, Roy E. Strowd, Michael A. Vogelbaum, Tobias Walbert, Susan M. Chang, Burt Nabors, Stuart A. Grossman, David A. Reardon, Patrick Y. Wen
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.