Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients
Lee EQ, Weller M, Sul J, Bagley SJ, Sahebjam S, van den Bent M, Ahluwalia M, Campian JL, Galanis E, Gilbert MR, Holdhoff M, Lesser GJ, Lieberman FS, Mehta MP, Penas-Prado M, Schreck KC, Strowd RE, Vogelbaum MA, Walbert T, Chang SM, Nabors LB, Grossman S, Reardon DA, and Wen PY. Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients. Neuro Oncol 2020.
Building on an initiative to enhance clinical trial participation involving the Society for Neuro-Oncology (SNO), the Response Assessment in Neuro-Oncology (RANO) 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, 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 barriers to accrual and discuss strategies to minimize such barriers for neuro-oncology trials.
ePub ahead of print