Analysis populations

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The set of subjects whose data are to be included in the main analyses should be defined in the statistical section of the protocol. There are usually different set of populations for safety and efficacy data.

  • Safety set
  • Full analysis set - The set of subjects that is as close as possible to the ideal implied by the intention-to-treat principle. It is derived from the set of all randomized subjects by minimal and justified elimination of subjects.
  • Intention to treat set - The principle that asserts that the effect of a treatment policy can be best assessed by evaluating on the basis of the intention to treat a subject (i.e. the planned treatment regimen) rather than the actual treatment given.
  • Per protocol set - The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.

References

  1. ICH E9 - Statistical Principles for Clinical Trials