In a Commentary article for Trials, Jonathan R. Emberson and colleagues summarise the experiences of the Data Monitoring Committee for the RECOVERY trial, a large-scale randomised trial of treatments for patients hospitalised with COVID-19.
]. For each intervention, our DMC report included just a handful of pages showing cumulative recruitment over time, baseline characteristics, treatments received during the admission period, 28-day Kaplan–Meier mortality curves , and a detailed table presenting the effect of treatment allocation on all pre-specified efficacy and safety outcomes. As new interventions were added, so were additional relevant safety assessments.
the Steering Committee, study staff, investigators, study participants, funders and other partners will remain blind to the interim results on study outcomes until 28 days after the last patient has been randomised for a particular intervention arm. Maintaining blinding of interim DMC results is essential. Any deliberate or inadvertent release of unblinded interim results from the DMC could prejudice the successful completion of the trial and would certainly damage the perceived integrity of this crucial trial oversight body.
the regulatory review of data from a trial is most demonstrably objective when the regulatory scientists charged with the review have not been part of the unblinded monitoring process]. If regulators gained access to even part of the unblinded data, it might lead to inappropriate premature closure of particular treatment arms.
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