Interim analysis

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Clinical trials are unique in that enrollment of patients is a continual process staggered in time. This means that if a treatment is particularly beneficial or harmful compared to the concurrent placebo group while the study is on-going, the investigators are ethically obliged to assess that difference using the data at hand and to make a deliberate consideration of terminating the study earlier than planned.

[edit] Statistical methods of interim analysis

[edit] Regulatory issues

[edit] Practical issues

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