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 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 Walbert; Susan M Chang; L Burt Nabors; Stuart Grossman; David A Reardon; Patrick Y Wen

doi:10.1093/neuonc/noaa015

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

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

Authors

Eudocia Q Lee^{1

2}, Michael Weller³, Joohee Sul⁴, Stephen J Bagley⁵, Solmaz Sahebjam⁶, Martin van den Bent⁷, Manmeet Ahluwalia⁸, Jian L Campian⁹, Evanthia Galanis¹⁰, Mark R Gilbert¹¹, Matthias Holdhoff¹², Glenn J Lesser¹³, Frank S Lieberman¹⁴, Minesh P Mehta¹⁵, Marta Penas-Prado¹¹, Karisa C Schreck¹², Roy E Strowd¹³, Michael A Vogelbaum⁶, Tobias Walbert¹⁶, Susan M Chang¹⁷, L Burt Nabors¹⁸, Stuart Grossman¹², David A Reardon^{1

2}, Patrick Y Wen^{1

2}

Affiliations

¹ Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
² Harvard Medical School, Boston, Massachusetts, USA.
³ University Hospital and University of Zurich, Zurich, Switzerland.
⁴ Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
⁵ Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁶ Moffitt Cancer Center, Tampa, Florida, USA.
⁷ Erasmus University Hospital, Rotterdam, Netherlands.
⁸ Cleveland Clinic, Cleveland, Ohio, USA.
⁹ Washington University, St Louis, Missouri, USA.
¹⁰ Mayo Clinic, Rochester, Minnesota, USA.
¹¹ Neuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
¹² The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, USA.
¹³ Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, USA.
¹⁴ University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
¹⁵ Miami Cancer Institute, Miami, Florida, USA.
¹⁶ Henry Ford Health System, Detroit, Michigan, USA.
¹⁷ University of California San Francisco, San Francisco, California, USA.
¹⁸ University of Alabama at Birmingham, Birmingham, Alabama, USA.

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.

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

Authors

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Abstract

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Grants and funding