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Methodology of intervention trials in individuals 

Methodology of intervention trials in individuals
Methodology of intervention trials in individuals

Lawrence M. Friedman

and Eleanor B. Schron

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date: 18 May 2022

The chapter on methodology of intervention trials in individuals presents key issues in the design, conduct, monitoring, analysis, and reporting of clinical trials. The chapter emphasizes the conduct of late phase trials, those performed in order to assess whether a new intervention is better than a control. Different sorts of trial design, including the special considerations of non-inferiority versus superiority trials are reviewed. The advantages and limitations of surrogate outcomes are covered, as is the use of quality of life as an outcome measure. The chapter discusses ethical issues, such as appropriateness of randomization, selection of the comparison group, clinical trials in emergency settings, and trials in developing countries. Approaches to data and safety monitoring are discussed, as are analysis issues such as intention-to-treat.

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