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http://hdl.handle.net/1942/31189
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DC Field | Value | Language |
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dc.contributor.author | Mallinckrodt, C. H. | - |
dc.contributor.author | Bell, J. | - |
dc.contributor.author | Liu, G | - |
dc.contributor.author | Ratitch, B. | - |
dc.contributor.author | O'Kelly, M. | - |
dc.contributor.author | Lipkovich, I | - |
dc.contributor.author | Singh, P. | - |
dc.contributor.author | Xu, L. | - |
dc.contributor.author | MOLENBERGHS, Geert | - |
dc.date.accessioned | 2020-05-22T12:55:40Z | - |
dc.date.available | 2020-05-22T12:55:40Z | - |
dc.date.issued | 2020 | - |
dc.date.submitted | 2020-05-04T12:13:18Z | - |
dc.identifier.citation | THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 54 (2) , p. 353 -364 | - |
dc.identifier.uri | http://hdl.handle.net/1942/31189 | - |
dc.description.abstract | The draft ICH E9(R1) addendum stipulates that an estimator should align with its associated estimand and yield an estimate that facilitates reliable interpretations. The addendum further stipulates that assumptions should be justifiable and plausible, and that the extent of assumptions is an important consideration for whether an estimate will be robust because assumptions are often unverifiable. The draft addendum specifies 5 strategies for dealing with intercurrent events. The intent of this paper is to provide conceptual considerations and technical details for various estimators that align with these strategies. We include focus on how the nature and extent of assumptions influences the potential robustness of the various estimators. The content reflects the knowledge, experience, and opinions of the Drug Information Association's Scientific Working Group on Missing Data. This group includes experienced statisticians from across industry and academia, primarily in the US and European Union. | - |
dc.description.sponsorship | We thank James Roger for providing technical descriptions of some of the reference-based imputation approaches described in the Appendix. We thank Jonathan Bartlett for his review. Most authors are members of the Drug Information Association Working Group on Missing Data. We benefited from discussion of key issues at our group's meetings. James Bell's contributions came from work that has been sponsored and initiated by Boehringer-Ingelheim Pharma GmbH & Co. KG. | - |
dc.language.iso | en | - |
dc.publisher | SPRINGER HEIDELBERG | - |
dc.rights | 2020 Springer Nature Switzerland AG. Part of Springer Nature. | - |
dc.subject.other | estimands | - |
dc.subject.other | estimation | - |
dc.subject.other | missing data | - |
dc.subject.other | sensitivity | - |
dc.title | Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice | - |
dc.type | Journal Contribution | - |
dc.identifier.epage | 364 | - |
dc.identifier.issue | 2 | - |
dc.identifier.spage | 353 | - |
dc.identifier.volume | 54 | - |
local.format.pages | 12 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.notes | O'Kelly, M (reprint author), IQVIA, Estuary House,East Point Business Pk, Dublin 3, Ireland. | - |
dc.description.notes | michael.okelly@iqvia.com | - |
dc.description.other | O'Kelly, M (reprint author), IQVIA, Estuary House,East Point Business Pk, Dublin 3, Ireland. michael.okelly@iqvia.com | - |
local.publisher.place | TIERGARTENSTRASSE 17, D-69121 HEIDELBERG, GERMANY | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
dc.source.type | Article | - |
dc.identifier.doi | 10.1007/s43441-019-00063-9 | - |
dc.identifier.pmid | 32072593 | - |
dc.identifier.isi | WOS:000522455300012 | - |
dc.identifier.eissn | 2168-4804 | - |
local.provider.type | wosris | - |
local.uhasselt.uhpub | yes | - |
item.fullcitation | Mallinckrodt, C. H.; Bell, J.; Liu, G; Ratitch, B.; O'Kelly, M.; Lipkovich, I; Singh, P.; Xu, L. & MOLENBERGHS, Geert (2020) Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice. In: THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 54 (2) , p. 353 -364. | - |
item.fulltext | No Fulltext | - |
item.validation | ecoom 2021 | - |
item.contributor | Mallinckrodt, C. H. | - |
item.contributor | Bell, J. | - |
item.contributor | Liu, G | - |
item.contributor | Ratitch, B. | - |
item.contributor | O'Kelly, M. | - |
item.contributor | Lipkovich, I | - |
item.contributor | Singh, P. | - |
item.contributor | Xu, L. | - |
item.contributor | MOLENBERGHS, Geert | - |
item.accessRights | Closed Access | - |
crisitem.journal.issn | 2168-4790 | - |
crisitem.journal.eissn | 2168-4804 | - |
Appears in Collections: | Research publications |
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