intention-to-treat principle
- Guideline or reference source
- ICHE9 Statistical principles for clinical trials
- Definition
- 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. It has the consequence that subjects allocated to a treatment group should be followed up, assessed and analysed as members of that group irrespective of their compliance to the planned course of treatment. The principle is intended to prevent bias caused by loss of participants that may reflect non- adherence to the protocol and disrupt baseline equivalence established by random assignment.
- Related Term
- full analysis set
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