Intention to treat and per protocol analysis in clinical trials

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...

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Veröffentlicht in:	Nephrology (Carlton, Vic.) Jg. 25; H. 7; S. 513 - 517
Hauptverfasser:	Tripepi, Giovanni, Chesnaye, Nicholas C., Dekker, Friedo W., Zoccali, Carmine, Jager, Kitty J.
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	Melbourne John Wiley & Sons Australia, Ltd 01.07.2020 Wiley Subscription Services, Inc
Schlagworte:	Clinical Protocols - standards Clinical trials Epidemiology Humans intention to treat analysis Intention to Treat Analysis - methods per protocol analysis randomized clinical trials Randomized Controlled Trials as Topic - methods Reproducibility of Results randomized clinical trials intention to treat analysis per protocol analysis
ISSN:	1320-5358, 1440-1797, 1440-1797
Online-Zugang:	Volltext
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Zusammenfassung:	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.
Bibliographie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Review-3 content type line 23
ISSN:	1320-5358 1440-1797 1440-1797
DOI:	10.1111/nep.13709