Premium
Intention to treat and per protocol analysis in clinical trials
Author(s) -
Tripepi Giovanni,
Chesnaye Nicholas C.,
Dekker Friedo W.,
Zoccali Carmine,
Jager Kitty J.
Publication year - 2020
Publication title -
nephrology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.752
H-Index - 61
eISSN - 1440-1797
pISSN - 1320-5358
DOI - 10.1111/nep.13709
Subject(s) - medicine , protocol (science) , randomized controlled trial , context (archaeology) , intention to treat analysis , clinical trial , medical physics , alternative medicine , surgery , pathology , paleontology , biology
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.