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How real is intention-to-treat (ITT) analysis in non-interventional post authorization safety studies? we can do better

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dc.contributor.author Kiri, Victor A.
dc.contributor.author MacKenzie, Gilbert
dc.date.accessioned 2013-06-05T15:01:37Z
dc.date.available 2013-06-05T15:01:37Z
dc.date.issued 2009
dc.identifier.uri http://hdl.handle.net/10344/3129
dc.description peer-reviewed en_US
dc.description.abstract Although cohort studies which are based on intention-to-treat (ITT) approach offer a simple design with data which are simpler to analyse and results easier to interpret, such studies also intrinsically assume that any time-varying treatment effect that exits can be adequately estimated by a fixed-effect component. However, such an assumption may not reflect real-life drug use. Reflection of real-life clinical practice is a major strength of epidemiologic safety studies. The failure to properly reflect reality may result in effect under-estimation leading to false and irreproducible conclusions due to exposure misclassification. In effect, the use of nested case-control design is a concession that ITT in cohort design may not be adequate. But the nested design also has its own sources of bias, including confounding by indication. We present an overview of the counter-matched version of the nested case-control, case-crossover, case-in-time, case series and case-cohort designs as alternatives in prospective postauthorization safety studies. en_US
dc.language.iso eng en_US
dc.publisher Bentham Science Publishers en_US
dc.relation.ispartofseries Current Drug Safety;4(2), pp. 137-142
dc.relation.uri http://www.benthamscience.com/cds/
dc.subject cohort study en_US
dc.subject selection bias en_US
dc.subject case-control design en_US
dc.subject counter-matching en_US
dc.title How real is intention-to-treat (ITT) analysis in non-interventional post authorization safety studies? we can do better en_US
dc.type info:eu-repo/semantics/article en_US
dc.type.supercollection all_ul_research en_US
dc.type.supercollection ul_published_reviewed en_US
dc.contributor.sponsor SFI en_US
dc.relation.projectid 07/MI/012 en_US
dc.rights.accessrights info:eu-repo/semantics/openAccess en_US


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