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Table 1 Questions. Difficult issues frequently discussed at DMC meetings

From: Experiences of the Data Monitoring Committee for the RECOVERY trial, a large-scale adaptive platform randomised trial of treatments for patients hospitalised with COVID-19

• How long should patients continue to be randomised to a treatment when the early data suggests a marginally negative trend, especially if the treatment is widely promoted as effective?

• How important is it that a negative result is ‘convincingly’ neutral, particularly when it is competing against other potentially beneficial treatments or when there are other treatments that could be introduced in its place?

• When is it appropriate for the DMC to perform their own futility analyses when such analyses have not been specified in the DMC charter?

• How to react to observational studies that are swaying opinions about a treatment?

• How much belief to put in the results of multiple interim subgroup analyses?

• How to respond to regulators’ requests for unblinded interim results?

• How to interact with other DMCs and what information should be shared with them?