Matches in SemOpenAlex for { <https://semopenalex.org/work/W4313592457> ?p ?o ?g. }
Showing items 1 to 95 of
95
with 100 items per page.
- W4313592457 endingPage "14" @default.
- W4313592457 startingPage "1" @default.
- W4313592457 abstract "Population enrichment designs can play a vital role in detecting treatment benefits, if present, by selecting a study population where the treatment is more likely to show a benefit compared to the unselected population. While population enrichment designs with one primary endpoint have been studied in the current literature, there are limited research on population enrichment with alternative primary endpoints. Many diseases have multiple sequelae and it can be sufficient to show treatment benefits on at least one of these consequences. In this manuscript, we provide the theoretical basis and development of a two-stage adaptive design with two binary alternative primary endpoints that simultaneously evaluates two subgroups for enrichment, selects one or both endpoints for efficacy assessments at the time of the interim analysis using pre-specified decision rules, and maintains an overall type I error rate. Treatment benefits can be declared in one or both endpoints in a selected subgroup or in the overall population at the time of interim or final analyses. We provide stage-wise boundary values for futility and efficacy and rejection probabilities under heterogeneous treatment effects in the subgroups. We further demonstrate the implementation of the proposed design and discuss venues for future development on this topic." @default.
- W4313592457 created "2023-01-06" @default.
- W4313592457 creator A5009342484 @default.
- W4313592457 creator A5030150444 @default.
- W4313592457 creator A5030247856 @default.
- W4313592457 creator A5042299275 @default.
- W4313592457 creator A5046150575 @default.
- W4313592457 creator A5052871735 @default.
- W4313592457 creator A5087909054 @default.
- W4313592457 date "2023-01-03" @default.
- W4313592457 modified "2023-09-29" @default.
- W4313592457 title "Simultaneous population enrichment and endpoint selection in phase 3 randomized controlled trials: An adaptive group sequential design with two binary alternative primary endpoints" @default.
- W4313592457 cites W1571725767 @default.
- W4313592457 cites W1573070924 @default.
- W4313592457 cites W1982816514 @default.
- W4313592457 cites W1989713165 @default.
- W4313592457 cites W2001030981 @default.
- W4313592457 cites W2040478536 @default.
- W4313592457 cites W2048265454 @default.
- W4313592457 cites W2074420293 @default.
- W4313592457 cites W2077419952 @default.
- W4313592457 cites W2091656201 @default.
- W4313592457 cites W2124110055 @default.
- W4313592457 cites W2126381284 @default.
- W4313592457 cites W2159026586 @default.
- W4313592457 cites W2159887611 @default.
- W4313592457 cites W2167471800 @default.
- W4313592457 cites W2273267066 @default.
- W4313592457 cites W2321563176 @default.
- W4313592457 cites W2532695412 @default.
- W4313592457 cites W2950034178 @default.
- W4313592457 cites W3009999522 @default.
- W4313592457 cites W4242589154 @default.
- W4313592457 doi "https://doi.org/10.1080/03610926.2022.2163180" @default.
- W4313592457 hasPublicationYear "2023" @default.
- W4313592457 type Work @default.
- W4313592457 citedByCount "0" @default.
- W4313592457 crossrefType "journal-article" @default.
- W4313592457 hasAuthorship W4313592457A5009342484 @default.
- W4313592457 hasAuthorship W4313592457A5030150444 @default.
- W4313592457 hasAuthorship W4313592457A5030247856 @default.
- W4313592457 hasAuthorship W4313592457A5042299275 @default.
- W4313592457 hasAuthorship W4313592457A5046150575 @default.
- W4313592457 hasAuthorship W4313592457A5052871735 @default.
- W4313592457 hasAuthorship W4313592457A5087909054 @default.
- W4313592457 hasConcept C105795698 @default.
- W4313592457 hasConcept C126322002 @default.
- W4313592457 hasConcept C149782125 @default.
- W4313592457 hasConcept C154945302 @default.
- W4313592457 hasConcept C166957645 @default.
- W4313592457 hasConcept C168563851 @default.
- W4313592457 hasConcept C203092338 @default.
- W4313592457 hasConcept C2776957806 @default.
- W4313592457 hasConcept C2908647359 @default.
- W4313592457 hasConcept C33923547 @default.
- W4313592457 hasConcept C41008148 @default.
- W4313592457 hasConcept C61943457 @default.
- W4313592457 hasConcept C71924100 @default.
- W4313592457 hasConcept C81917197 @default.
- W4313592457 hasConcept C95457728 @default.
- W4313592457 hasConcept C99454951 @default.
- W4313592457 hasConceptScore W4313592457C105795698 @default.
- W4313592457 hasConceptScore W4313592457C126322002 @default.
- W4313592457 hasConceptScore W4313592457C149782125 @default.
- W4313592457 hasConceptScore W4313592457C154945302 @default.
- W4313592457 hasConceptScore W4313592457C166957645 @default.
- W4313592457 hasConceptScore W4313592457C168563851 @default.
- W4313592457 hasConceptScore W4313592457C203092338 @default.
- W4313592457 hasConceptScore W4313592457C2776957806 @default.
- W4313592457 hasConceptScore W4313592457C2908647359 @default.
- W4313592457 hasConceptScore W4313592457C33923547 @default.
- W4313592457 hasConceptScore W4313592457C41008148 @default.
- W4313592457 hasConceptScore W4313592457C61943457 @default.
- W4313592457 hasConceptScore W4313592457C71924100 @default.
- W4313592457 hasConceptScore W4313592457C81917197 @default.
- W4313592457 hasConceptScore W4313592457C95457728 @default.
- W4313592457 hasConceptScore W4313592457C99454951 @default.
- W4313592457 hasLocation W43135924571 @default.
- W4313592457 hasOpenAccess W4313592457 @default.
- W4313592457 hasPrimaryLocation W43135924571 @default.
- W4313592457 hasRelatedWork W1930140912 @default.
- W4313592457 hasRelatedWork W2059141528 @default.
- W4313592457 hasRelatedWork W2081238229 @default.
- W4313592457 hasRelatedWork W2094558159 @default.
- W4313592457 hasRelatedWork W2156774182 @default.
- W4313592457 hasRelatedWork W2207249009 @default.
- W4313592457 hasRelatedWork W2392263094 @default.
- W4313592457 hasRelatedWork W2908454381 @default.
- W4313592457 hasRelatedWork W2970352569 @default.
- W4313592457 hasRelatedWork W2981319632 @default.
- W4313592457 isParatext "false" @default.
- W4313592457 isRetracted "false" @default.
- W4313592457 workType "article" @default.