This chapter provides a refresher on biostatistics, specific to clinical trials, and a glossary of terms and definitions relevant to the analyses of clinical trials. The question, in the class of trials considered here (superiority, randomized phase III or IV trials with parallel-treatment designs), is whether the results are sufficient to conclude that the test treatment is superior to the comparison control treatment. The approach in addressing the question depends on the school of thought guiding the analysis, broadly: Bayesian, likelihood, and frequentist.
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