• 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? |