TY - JOUR
T1 - Intention to treat and per protocol analysis in clinical trials
AU - Tripepi, Giovanni
AU - Chesnaye, Nicholas C.
AU - Dekker, Friedo W.
AU - Zoccali, Carmine
AU - Jager, Kitty J.
PY - 2020/7/1
Y1 - 2020/7/1
N2 - 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.
AB - 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.
KW - intention to treat analysis
KW - per protocol analysis
KW - randomized clinical trials
UR - http://www.scopus.com/inward/record.url?scp=85081754755&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/nep.13709
DO - https://doi.org/10.1111/nep.13709
M3 - Review article
C2 - 32147926
SN - 1320-5358
VL - 25
SP - 513
EP - 517
JO - Nephrology (Carlton, Vic.)
JF - Nephrology (Carlton, Vic.)
IS - 7
ER -