e13576 Background: The COVID-19 pandemic has had profound detrimental consequences on cancer patient outcomes and clinical cancer research, with considerable adaptations made to both standard care and clinical research to optimise patient safety. Detailed perspectives of clinical researchers on such risk mitigation, and granular insight into which adaptions should persist long term, are required to inform future clinical trial design. Methods: We designed and performed an in depth, global survey (open between 04/22/20 and 06/10/2020) of cancer research professionals to assess the impact of the pandemic on clinical care and research, and how researchers prioritise and view clinical research methodologies. Results: 162 valid responses were received (58.7% oncologists, 14.8% research nurses; 69.1% working in academic centers) from six continents. There was significant heterogeneity in how the pandemic has affected healthcare workers, patients on standard of care or investigational trial treatments, and clinical trial recruitment. Our results detail how trial and non-trial patient care has altered in respondents’ centres and how respondents would prioritise specific trial designs while the pandemic continues. We show marked variance in the perceived value of specific trial protocol features and assessments (regardless of the pandemic). More respondents agreed than disagreed that trial eligibility criteria are too restrictive (48% agreed versus 28% disagreed), that screening assessments generally have unnecessary tests (51% versus 23%), that physical examination should only be performed when clinically indicated (43% versus 30%), that electronic patient outcomes/questionnaires are better at detecting adverse events that a consultation with a study doctor (33% versus 29%), that wearable technology/validated tools for patients to perform self-examination would provide more useful information than vital sign assessment in the study center (48% versus 13%), and that replacing routine in person visits with virtual visits would not significantly compromise patient safety (36% versus 28%). However, 65% of respondents indicated that fully virtual clinical trials (in the absence of reported clinically significant toxicities) would not be sufficiently safe (versus 15% who indicated that they would be). Conclusions: These detailed data provide further evidence of a significant adverse impact of the pandemic on cancer patient care and drug development, may help inform risk mitigation for studies in times of heightened infection risk, and aid with future clinical trial design.
A novel equivalence probability weighted power prior for using historical control data in an adaptive clinical trial design: A comparison to standard methods
