- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
9.3 Statistical analysis
The type(s) of statistical analyses to be used must be specified in the protocol, and any other subsequent deviations from this plan should be justified and described in the final report of the clinical trial. The statistical analysis should be planned and carried out or verified by an identified, appropriately qualified and experienced statistician. The possibility and circumstances of interim analyses must also be specified in the protocol.
The investigator and the monitor must ensure that the data are of the highest quality possible at the point of collection and the statistician must ensure the integrity of the data during processing.
The results of statistical analyses should be presented in such a manner as to facilitate interpretation of their clinical importance, e.g. as estimates of the magnitude of the treatment effect, the difference between treatments and confidence intervals, rather than in a form that relies solely on significance testing.
An account must be made of missing, unused or spurious data excluded during statistical analyses. All such exclusions must be documented so that they can be reviewed if necessary.