Statistical Thinking in Clinical Trials (2021)

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This book is for biostatisticians intent on learning statistical techniques and intuition for clinical trials. We focus on a relatively small number of statistical principles and many instructive trials such as the Extracorporeal Membrane Oxygenation (ECMO) Trial, the Cardiac Arrhythmia Suppression Trial (CAST), and the Women’s Health Initiative. Some principles we present resulted from mistakes made and lessons learned. Other principles allow quick calculation of quantities such as power or sample size with no need for computer programs. For example, the ‘EZ’ principle shows that there is a single, simple equation that can be used to approximate power, sample size, or detectable effect in many different clinical trial scenarios. All that matters is EZ, the expected value of the z-statistic. Accommodating monitoring is also a snap with the EZ principle.

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