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Consideration of stratification in confirmatory trials with time-to-event endpoint.
- Source :
-
Contemporary Clinical Trials . Jun2024, Vol. 141, pN.PAG-N.PAG. 1p. - Publication Year :
- 2024
-
Abstract
- Stratification in randomization and analysis are widely employed to balance treatment groups in clinical trials. However, the potential power loss due to under-stratification or over-stratification has not been thoroughly evaluated in the typical setting of confirmatory clinical trials. In cases where there are too many strata and some have small sample sizes or a small number of events, it is common practice to combine these small strata during analysis. However, there is a lack of guidance on how those small strata should be combined. This paper presents extensive simulation studies to evaluate the impact of under-stratification or over-stratification on the power of survival analysis and the estimate of hazard ratio using stratified log-rank test and Cox PH model, respectively. The difference in power between stratified and unstratified log-rank tests is also investigated under different scenarios. Our results suggest that failing to consider prognostic stratification factors with strong effects, and/or accounting for non-prognostic factors such as noise and predictive factors, may reduce the power of the stratified log-rank test. Additionally, methods of combining small strata are explored and compared. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 15517144
- Volume :
- 141
- Database :
- Academic Search Index
- Journal :
- Contemporary Clinical Trials
- Publication Type :
- Academic Journal
- Accession number :
- 177224187
- Full Text :
- https://doi.org/10.1016/j.cct.2024.107434