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Judgment & ambiguity · Decisions under uncertainty

During an interim safety review of an ongoing trial, you notice a small imbalance in a serious adverse event between arms — it could be chance at this sample size, or an early safety signal. Enrollment is active. What do you decide, and when?

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Participant safety sets the tempo here, so I don't wait for statistical certainty that might arrive after someone's been harmed — but I also don't unblind or halt on noise, because

The full answer: structure, worked example, likely follow-up.

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