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J.Jpn. Surg. Soc.. 117(1): 33-39, 2016

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Department of Biostatistics, Yokohama City University, Yokohama, Japan

Kentaro Sakamaki, Takeharu Yamanaka

Clinical trials are conducted based on the development of surgical technology and are designed to answer specific research questions. In planning clinical trials population, intervention, comparison, and outcome are important elements. Sample size calculation is also central to the design of clinical trials, especially randomized, controlled ones. This article outlines study phases, four important elements of design, and sample size calculation.

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