Matches in SemOpenAlex for { <https://semopenalex.org/work/W1568375961> ?p ?o ?g. }
Showing items 1 to 68 of
68
with 100 items per page.
- W1568375961 abstract "The FDA largely approves or disapproves drugs based on average treatment effects. Given widespread heterogeneity in treatment response, this approach can result in the approval of drugs with significant negative effects for identifiable subgroups (false positives) and in the non-approval of drugs with significant positive effects for identifiable subgroups (false negatives). Despite the FDA's position, drug companies frequently conduct post hoc subgroup analysis - a search for responsive subgroups - after their clinical trials find no positive average treatment effects. The FDA rejects such analysis due to the risk of spurious results. With sufficient covariate measurements, a drug company can always find some subgroup that benefits from a drug. This paper asks whether there workable compromise between the FDA and drug companies. Specifically, we seek a drug approval process that can use post hoc subgroup analysis to eliminate false negatives but does not risk opportunistic behavior and spurious correlation. The primary reform we recommend is a statistical analysis of a random subset of the data set from a clinical trial by an independent researcher. The subsample examined by the independent researcher can eliminates the risk of spurious findings due to multiple testing in the remainder of the sample. We apply our approach to the results of a recent clinical trial of a cancer drug, Xcytrin, that failed to find positive average treatment effects, and discover positive treatment effects for an important subset of patients." @default.
- W1568375961 created "2016-06-24" @default.
- W1568375961 creator A5060422059 @default.
- W1568375961 creator A5069384506 @default.
- W1568375961 creator A5084941944 @default.
- W1568375961 date "2008-01-01" @default.
- W1568375961 modified "2023-09-27" @default.
- W1568375961 title "Reforming Subgroup Analysis" @default.
- W1568375961 doi "https://doi.org/10.2139/ssrn.1119970" @default.
- W1568375961 hasPublicationYear "2008" @default.
- W1568375961 type Work @default.
- W1568375961 sameAs 1568375961 @default.
- W1568375961 citedByCount "0" @default.
- W1568375961 crossrefType "journal-article" @default.
- W1568375961 hasAuthorship W1568375961A5060422059 @default.
- W1568375961 hasAuthorship W1568375961A5069384506 @default.
- W1568375961 hasAuthorship W1568375961A5084941944 @default.
- W1568375961 hasConcept C105795698 @default.
- W1568375961 hasConcept C119043178 @default.
- W1568375961 hasConcept C126322002 @default.
- W1568375961 hasConcept C144133560 @default.
- W1568375961 hasConcept C149782125 @default.
- W1568375961 hasConcept C162118730 @default.
- W1568375961 hasConcept C187960798 @default.
- W1568375961 hasConcept C2780035454 @default.
- W1568375961 hasConcept C2992886853 @default.
- W1568375961 hasConcept C33923547 @default.
- W1568375961 hasConcept C535046627 @default.
- W1568375961 hasConcept C64869954 @default.
- W1568375961 hasConcept C67761136 @default.
- W1568375961 hasConcept C71924100 @default.
- W1568375961 hasConcept C95190672 @default.
- W1568375961 hasConcept C97256817 @default.
- W1568375961 hasConcept C98274493 @default.
- W1568375961 hasConceptScore W1568375961C105795698 @default.
- W1568375961 hasConceptScore W1568375961C119043178 @default.
- W1568375961 hasConceptScore W1568375961C126322002 @default.
- W1568375961 hasConceptScore W1568375961C144133560 @default.
- W1568375961 hasConceptScore W1568375961C149782125 @default.
- W1568375961 hasConceptScore W1568375961C162118730 @default.
- W1568375961 hasConceptScore W1568375961C187960798 @default.
- W1568375961 hasConceptScore W1568375961C2780035454 @default.
- W1568375961 hasConceptScore W1568375961C2992886853 @default.
- W1568375961 hasConceptScore W1568375961C33923547 @default.
- W1568375961 hasConceptScore W1568375961C535046627 @default.
- W1568375961 hasConceptScore W1568375961C64869954 @default.
- W1568375961 hasConceptScore W1568375961C67761136 @default.
- W1568375961 hasConceptScore W1568375961C71924100 @default.
- W1568375961 hasConceptScore W1568375961C95190672 @default.
- W1568375961 hasConceptScore W1568375961C97256817 @default.
- W1568375961 hasConceptScore W1568375961C98274493 @default.
- W1568375961 hasLocation W15683759611 @default.
- W1568375961 hasOpenAccess W1568375961 @default.
- W1568375961 hasPrimaryLocation W15683759611 @default.
- W1568375961 hasRelatedWork W2001319233 @default.
- W1568375961 hasRelatedWork W2011945577 @default.
- W1568375961 hasRelatedWork W2026748440 @default.
- W1568375961 hasRelatedWork W2136180645 @default.
- W1568375961 hasRelatedWork W2746862840 @default.
- W1568375961 hasRelatedWork W2765153054 @default.
- W1568375961 hasRelatedWork W2931838652 @default.
- W1568375961 hasRelatedWork W2949263084 @default.
- W1568375961 hasRelatedWork W2955504986 @default.
- W1568375961 hasRelatedWork W2955725829 @default.
- W1568375961 isParatext "false" @default.
- W1568375961 isRetracted "false" @default.
- W1568375961 magId "1568375961" @default.
- W1568375961 workType "article" @default.