This article discusses data safety monitoring during Covid‐19. the pandemic of Covid‐19 has created the imperative for new treatments and a vaccine, countless clinical trials already in progress have still needed oversight. With the emergence of Covid-19, studies needed to quickly adapt because what it meant to protect study participants wasn’t the same as it had been weeks earlier. One of the primary roles of DSMBs is to evaluate interim data to ensure that participants aren’t at additional risk by virtue of being randomized to a study arm found to have more risks or fewer benefits than other arms. Stopping a study early when it falls out of equipoise is the most monumental task a data safety monitoring boards (DSMB) is charged to perform. The pandemic brought with it risks that changed many studies’ risk-benefit calculus. In some cases, merely attending a visit to report symptoms, check progress, verify pill counts, or report adverse events posed additional risk. Participants in placebo arms are typically expected to experience little benefit, and certainly not greater harm, than participants in the active therapy group. Suddenly, participating in even the most innocuous placebo arm might result in unforeseen harm. DSMBs’ primary responsibility is to protect research participants, but if data is compromised, then the benefit of the study will never outweigh the risks to participants. Thus, protecting the integrity of data collection was also foremost in the minds of DSMB members. Researchers, representatives from the National Institutes of Health, and DSMB members were in constant communication about trials already in progress.
Ethics & Human Research
Barnbaum, D. (2020). Data safety monitoring during covid‐19: Keep on keeping on. Ethics & Human Research. https://doi.org/https://doi.org/10.1002/eahr.500053
Barnbaum, Deborah. 2020. “Data Safety Monitoring During covid‐19: Keep on Keeping on”. Ethics & Human Research. https://doi.org/https://doi.org/10.1002/eahr.500053.
Barnbaum, D. Data Safety Monitoring During covid‐19: Keep on Keeping on. Ethics & Human Research, 18 May 2020, doi:https://doi.org/10.1002/eahr.500053.