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Case Study:
Clinical Trial In Gm- Sepsis
Randomized, placebo controlled Phase III study of antibody to endotoxin
–Intervention: Single administration
–Endpoint: Difference in 28 day mortality rates
•Placebo arm: estimate 30% mortality
•Treatment arm: hope for 23% mortality
–Analysis: Large sample test of binomial proportions
•Frequentist based inference
•Type I error: one-sided 0.025
•Power: 90% to detect θ < -0.07
•Point estimate with low bias, MSE; 95% CI
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