Report of National Brain Tumor Society roundtable workshop on innovating brain tumor clinical trials: building on lessons learned from COVID-19 experience

Eudocia Q Lee; Wendy Selig; Clair Meehan; Jeffrey Bacha; Amy Barone; Erik Bloomquist; Susan M Chang; John F de Groot; Evanthia Galanis; Islam Hassan; Chitkala Kalidas; Mustafa Khasraw; Joseph C Kvedar; Andrew B Lassman; Vinay Puduvalli; Solmaz Sahebjam; Lee H Schwamm; Sharon Tamir; Mary Welch; W K Alfred Yung; Gelareh Zadeh; David Arons; Patrick Y Wen

doi:10.1093/neuonc/noab082

Report of National Brain Tumor Society roundtable workshop on innovating brain tumor clinical trials: building on lessons learned from COVID-19 experience

Neuro Oncol. 2021 Aug 2;23(8):1252-1260. doi: 10.1093/neuonc/noab082.

Authors

Eudocia Q Lee¹, Wendy Selig², Clair Meehan³, Jeffrey Bacha⁴, Amy Barone⁵, Erik Bloomquist⁶, Susan M Chang⁷, John F de Groot⁸, Evanthia Galanis⁹, Islam Hassan¹⁰, Chitkala Kalidas¹¹, Mustafa Khasraw¹², Joseph C Kvedar¹³, Andrew B Lassman¹⁴, Vinay Puduvalli⁸, Solmaz Sahebjam¹⁵, Lee H Schwamm¹⁶, Sharon Tamir¹⁷, Mary Welch¹⁴, W K Alfred Yung⁸, Gelareh Zadeh¹⁸, David Arons³, Patrick Y Wen¹

Affiliations

¹ Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
² WSCollaborative, McLean, Virginia, USA.
³ National Brain Tumor Society, Newton, Massachusetts, USA.
⁴ Edison Oncology Holding Corp., Menlo Park, California, USA.
⁵ Office of Hematology and Oncology Products at the Food and Drug Administration, Silver Spring, Maryland, USA.
⁶ Office of Biostatistics, Center for Drug Evaluation and Research at the Food and Drug Administration, Silver Spring, Maryland, USA.
⁷ Department of Neurological Surgery, University of California, San Francisco, San Francisco, California, USA.
⁸ Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
⁹ Division of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.
¹⁰ Agios Pharmaceuticals, Cambridge, Massachusetts, USA.
¹¹ Bayer Pharmaceuticals, Hillsborough, New Jersey, USA.
¹² Preston Robert Tisch Brain Tumor Center at Duke, Departments of Neurosurgery, Duke University Medical Center, Durham, North Carolina, USA.
¹³ Department of Dermatology at Massachusetts General Hospital, Boston, Massachusetts, USA.
¹⁴ Department of Neurology and Herbert Irving Comprehensive Cancer Center, New-York Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York, USA.
¹⁵ Department of Neuro-Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
¹⁶ Department of Neurology at Massachusetts General Hospital, Boston, Massachusetts, USA.
¹⁷ Karyopharm Therapeutics, Inc., Newton, Massachusetts, USA.
¹⁸ MacFeeters-Hamilton Center for Neuro-Oncology, Princess Margaret Cancer Center, Toronto, Ontario, Canada.

Abstract

On July 24, 2020, a workshop sponsored by the National Brain Tumor Society was held on innovating brain tumor clinical trials based on lessons learned from the COVID-19 experience. Various stakeholders from the brain tumor community participated including the US Food and Drug Administration (FDA), academic and community clinicians, researchers, industry, clinical research organizations, patients and patient advocates, and representatives from the Society for Neuro-Oncology and the National Cancer Institute. This report summarizes the workshop and proposes ways to incorporate lessons learned from COVID-19 to brain tumor clinical trials including the increased use of telemedicine and decentralized trial models as opportunities for practical innovation with potential long-term impact on clinical trial design and implementation.

Keywords: COVID-19; clinical trials; decentralization; telemedicine.

MeSH terms

Brain Neoplasms* / therapy
COVID-19*
Humans
National Cancer Institute (U.S.)
SARS-CoV-2
United States
United States Food and Drug Administration

Grants and funding

P30 CA014236/CA/NCI NIH HHS/United States