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

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.

Clinical Trial Considerations in Neuro-oncology

“…Working groups within RANO, including iRANO and RANO-BM, continue to validate and refine their initial radiographic response criteria. The National Brain Tumor Society held a workshop in July 2020 on innovating brain tumor clinical trials based on lessons learned from the COVID-19 experience with participation from various stakeholders including the US Food and Drug Administration (FDA), academic and community clinicians, researchers, industry, clinical research organizations, patients and patient advocates, and representatives from SNO and the National Cancer Institute [48]. Consensus recommendations from the workshop include further development of virtual neurooncologic assessment, evaluation of which clinical trial elements can be decentralized, and more widespread adoption of the standardized imaging protocols for primary brain tumor [57••] and brain metastases [58••] trials to support enhanced imaging expertise in the community setting.…”

“…& Decentralized clinical trials utilize novel technologies or processes to collect study data, thus allowing the study to be designed around patients and not sponsors or sites [47]. & The COVID-19 pandemic has changed the way we practice medicine and allows us to re-envision the conduct of clinical trials [48]. Traditional clinical trial design generally requires all study-related visits and procedures to be performed at the research site.…”

Lessons for Oncology From the COVID-19 Pandemic

“…Given the projected shortages of oncologists in many areas, 80 virtual care can provide important tools to connect patients and providers. The potential to improve patient care is even greater in the era of precision medicine as virtual care can more easily connect experts on rare malignancies and uncommon mutations with patients to assist with management and consider for clinical trials 12,81,82 . In addition, many oncology patients have limited functional status that can increase barriers to travel and in-person visits.…”

“…The potential to improve patient care is even greater in the era of precision medicine as virtual care can more easily connect experts on rare malignancies and uncommon mutations with patients to assist with management and consider for clinical trials. 12 , 81 , 82 In addition, many oncology patients have limited functional status that can increase barriers to travel and in-person visits. Virtual care can help patients with limited mobility receive medical care in their homes.…”

How has the COVID-19 pandemic impacted clinical care and research in Neuro-Oncology?

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