Statistical Issues in Drug Research and Development 2017
DOI: 10.1201/9780203738610-8
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7 Intention to Treat in Clinical Trials

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Cited by 111 publications
(107 citation statements)
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“…The ITT estimation is often regarded in the program evaluation literature as a solution to the imperfect compliance problem [Fisher, Dixon, Herson, Frankowski, Hearron, and Peace (1990)]. ITT analysis strictly depends on the randomized treatment assignment and ignores all sorts of non-compliance in the post-protocol period.…”
Section: Identification Strategymentioning
confidence: 99%
“…The ITT estimation is often regarded in the program evaluation literature as a solution to the imperfect compliance problem [Fisher, Dixon, Herson, Frankowski, Hearron, and Peace (1990)]. ITT analysis strictly depends on the randomized treatment assignment and ignores all sorts of non-compliance in the post-protocol period.…”
Section: Identification Strategymentioning
confidence: 99%
“…Analysis was performed by the principle of intention to treat (ITT), with analyses conducted according to assignment at randomisation 16,17 . The intention to treat principle allows for modification due to missing data, for which there is no completely satisfactory remedy since strong assumptions are required regardless of the approach taken 18,19 .…”
Section: Discussionmentioning
confidence: 99%
“…ITT has been adopted and mandated by the Food and Drug Administration (FDA) as the preferred approach for analyzing randomized clinical trials (174). The American Statistical Association defined ITT as "one which includes all randomized patients in the groups to which they were randomly assigned, regardless of their compliance with the entry criteria, regardless of the treatment they actually received, and regardless of subsequent withdrawal from treatment or deviation from the protocol" (175).…”
Section: Discussionmentioning
confidence: 99%