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Data Safety Monitoring during Covid-19: Keep On Keeping On

ABSTRACT: Data safety monitoring of clinical trials already in progress hasn’t stopped with Covid-19. Instead, data safety monitoring boards (DSMBs) are quickly adapting to rapid change and significant uncertainty. This first-hand essay describes the work of several DSMBs for National Institutes of Health-sponsored studies. Some trials are suspended temporarily, some are moving forward in limited fashion, and others have added ancillary studies to explore possible coronavirus treatments. In each case, the protection of human subjects and the integrity of data collection remain DSMBs’ main concerns. Lessons learned when monitoring studies in extraordinary times concern the continued prioritization of human subject protection and primary study endpoints, flexibility as new circumstances alter risk-benefit ratios, the importance of close communication between DSMBs and researchers, and the continued embrace of the principles that guide data safety monitoring. The pandemic will pass, but lessons reinforced while working under the shadow of Covid-19 should persist.

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