Abstract
Clinical trials are planned experiments that measure the effectiveness of an intervention by comparing outcomes in a group of subjects treated with the test intervention with those observed in a comparable group of subjects receiving another intervention. As a result, clinical trials require investigators to assume significant responsibility and often consume significant human and financial resources. This chapter describes implementation of the study, including formulating the protocol from the study question; inclusion and exclusion criteria; pretesting and quality control; missing data; standardization, blinding, and randomization; planning for data management, monitoring, and audits; interim analyses; and the components of the research team. Because biostatistics plays a critical role in the interpretation of clinical trial results, this chapter discusses hypotheses and underlying principles, Type I and II errors, estimating sample size and power, strategies for minimizing sample size, statistical tests of significant, and relative risk. This review contains 32 references.
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