Clinical trials in sepsis to date have failed to demonstrate efficacy for this complex and highly fatal syndrome. Attention to clinical trial design and analysis can help assess therapies more accurately. The method in which a sepsis trial is analyzed must be planned prospectively and in detail. This plan should describe all analyses, primary and others, and how they will be done. Recommendations for design and analysis for preclinical studies, and Phase 1, 2, and 3 trials are provided.
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