Clinical Trial Protocol Specifies The Statistical Analysis
The data are analyzed using the statistical method that was specified in the clinical trial protocol, which needs to have been approved by the appropriate institutional review boards and regulatory agencies before the trial could begin. Again, the clinical trial protocols specify the method of statistical analysis. Most clinical trials are analyzed using repeated-measurements anova (analysis of variance) or mixed linear models that include random effects.
In most longitudinal studies of human subjects, patients may withdraw from the trial or become "lost to follow-up" (due e.g. to moving abroad or to dying from another disease). There are statistical methods for dealing with such missing-data and "censoring" problems. An important method analyzes the data according to the principle of the intention to treat.
Read more about this topic: Crossover Study
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