Meta-Analysis Protocol Document

CDISC-Gloss – The document describing the plan for combining evidence from relevant studies using appropriate statistical methods to allow inference to be made to the population of interest. NOTE: The most common reason for performing a meta-analysis is to provide an estimate of a treatment effect or measure of relative risk associated with an intervention and to quantify the uncertainty about the estimated effect or risk, when data from a single existing study are insufficient for this purpose. [FDA Draft Guidance, Meta- Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry, November 2018] See also meta-analysis.