Ethics and Stopping Rules in a Phase II Clinical Trial

Carefully designed experiments, known as (controlled) clinical trials, have been used to evaluate (competing) treatments since 1950. The first clinical trial was conducted just after World War II and involved an evaluation of streptomycin in the treatment of pulmonary tuberculosis. Statisticians play a key role in the design and analysis of modern clinical trials. Design choices—including randomization, blocking, sample size, and power—have fundamentally statistical components. Analyzing and reporting clinical trials also involve using statistical methods and insight.

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