Controversial Statistical Issues in Clinical Trials

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Covering a number of controversial issues that are commonly encountered when conducting clinical trials, this book serves as a useful desk reference and an assessment of the current state of the art. It discusses the appropriateness of traditional statistical hypotheses (which primarily focus on efficacy) for clinical evaluation of both efficacy and safety, instability of classical sample size calculation based on information from a small pilot study, and integrity of randomization and blinding. The author illustrates the issues using real-world examples and up-to-date data. He also provides recommendations of possible resolutions of these issues.