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- Title
Intention to treat and per protocol analysis in clinical trials.
- Authors
Tripepi, Giovanni; Chesnaye, Nicholas C.; Dekker, Friedo W.; Zoccali, Carmine; Jager, Kitty J.
- Abstract
In clinical epidemiology, experimental studies usually take the form of randomized controlled clinical trials (RCTs). The data analysis of an RCT can be performed by using two complementary strategies, that is according to the intention to treat (ITT) principle and the per protocol (PP) analysis. By using the ITT approach, investigators aim to assess the effect of assigning a drug whereas by adopting the PP analysis, researchers investigate the effect of receiving the assigned treatment, as specified in the protocol. Both ITT and PP analyses are essentially valid but they have different scopes and interpretations dependent on the context. SUMMARY AT A GLANCE: RCTs are analyzed according to the intention to treat (ITT) principle and the per protocol (PP) approach. The authors explained how ITT aims to assess the effect of assigning a drug and how the PP analysis investigates the effect of receiving an assigned treatment. Both analyses are valid but have different scopes and interpretations depending on the context.
- Subjects
CLINICAL trials; MEDICAL protocols; INTENTION; CLINICAL epidemiology; PHARMACODYNAMICS
- Publication
Nephrology, 2020, Vol 25, Issue 7, p513
- ISSN
1320-5358
- Publication type
Article
- DOI
10.1111/nep.13709