Abstract:
:Randomized controlled clinical trials often use a composite endpoint as a primary endpoint especially when treatment effects or frequency of individual components of the composite are likely to be small and combining them makes clinical sense for the disease under study. An advantage of the composite endpoint is that, as it combines multiple endpoints to a single endpoint, it reduces or eliminates the multiplicity problem of testing multiple endpoints. In addition, accumulating evidence from individual endpoints into the composite endpoint can lead to better study power and reduce the study size and the duration of the trial. However, composite endpoints can also lead to ambiguous findings and consequently cause difficulty in interpreting study results, for example, when individual component endpoints of a composite show treatment effects in different directions. Also, multiplicity issues will arise if a study sponsor seeks efficacy claims for specific components of the composite or for a targeted subgroup of patients. This paper visits some of these issues and presents some solutions through applications of multiple testing strategies.
journal_name
J Biopharm Statjournal_title
Journal of biopharmaceutical statisticsauthors
Huque MF,Alosh M,Bhore Rdoi
10.1080/10543406.2011.551327subject
Has Abstractpub_date
2011-07-01 00:00:00pages
610-34issue
4eissn
1054-3406issn
1520-5711pii
936782823journal_volume
21pub_type
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