Abstract
Background:Clinical trials, conducted efficiently and with the utmost integrity, are a key component in identifying effective vaccines, therapies, and other interventions urgently needed to solve the COVID-19 crisis. Yet launching and implementing trials with the rigor necessary to produce convincing results is a complicated and time-consuming process. Balancing rigor and efficiency involves relying on designs that employ flexible features to respond to a fast-changing landscape, measuring valid endpoints that result in translational actions and disseminating findings in a timely manner. We describe the challenges involved in creating infrastructure with potential utility for shared learning.Methods:We have established a shared infrastructure that borrows strength across multiple trials. The infrastructure includes an endpoint registry to aid in selecting appropriate endpoints, a registry to facilitate establishing a Data & Safety Monitoring Board, common data collection instruments, a COVID-19 dedicated design and analysis team, and a pragmatic platform protocol, among other elements.Results:The authors have relied on the shared infrastructure for six clinical trials for which they serve as the Data Coordinating Center and have a design and analysis team comprising 15 members who are dedicated to COVID-19. The authors established a pragmatic platform to simultaneously investigate multiple treatments for the outpatient with adaptive features to add or drop treatment arms.Conclusion:The shared infrastructure provides appealing opportunities to evaluate disease in a more robust manner with fewer resources and is especially valued during a pandemic where efficiency in time and resources is crucial. The most important element of the shared infrastructure is the pragmatic platform. While it may be the most challenging of the elements to establish, it may provide the greatest benefit to both patients and researchers.
Highlights
Clinical trials, conducted efficiently and with the utmost integrity, are a key component in identifying effective vaccines, therapies, and other interventions urgently needed to solve the COVID-19 crisis
We developed an international registry to aid in identifying an appropriate Data & Safety Monitoring Board with diverse expertise and composition
Governance should include four entities: a Steering Committee to drive key scientific decisions; a Drug Working Group, a subset of the Steering Committee, to help prioritize agents and combinations of drugs to consider; a single Data & Safety Monitoring Board to advise the Steering Committee; and a Statistical Analysis Committee to advise the Data & Safety Monitoring Board on ongoing safety and efficacy data (Figure 4). As of this writing (November 2020) at Stanford, we have 40 total COVID-19 related trials pending or launched (14 of these are Stanford investigator-initiated, and 10 of the 40 trials are intended for the outpatient population)
Summary
Clinical trials, conducted efficiently and with the utmost integrity, are a key component in identifying effective vaccines, therapies, and other interventions urgently needed to solve the COVID-19 crisis. Balancing rigor and efficiency involves relying on designs that employ flexible features to respond to a fast-changing landscape, measuring valid endpoints that result in translational actions and disseminating findings in a timely manner. The infrastructure includes an endpoint registry to aid in selecting appropriate endpoints, a registry to facilitate establishing a Data & Safety Monitoring Board, common data collection instruments, a COVID-19 dedicated design and analysis team, and a pragmatic platform protocol, among other elements. Results: The authors have relied on the shared infrastructure for six clinical trials for which they serve as the Data Coordinating Center and have a design and analysis team comprising 15 members who are dedicated to COVID-19. The most important element of the shared infrastructure is the pragmatic platform While it may be the most challenging of the elements to establish, it may provide the greatest benefit to both patients and researchers. Generation and approval of trialrelated documents Selection of trial sites and properly qualified, trained, and experienced investigators and study personnel Ethics committee review and approval of protocol
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