|Title||Flexible stopping boundaries when changing primary endpoints after unblinded interim analyses.|
|Publication Type||Journal Article|
|Year of Publication||2014|
|Authors||Chen, Liddy M., Joseph G. Ibrahim, and Haitao Chu|
|Journal||J Biopharm Stat|
|Keywords||Clinical Trials as Topic, Endpoint Determination, Humans, Research Design|
It has been widely recognized that interim analyses of accumulating data in a clinical trial can inflate type I error. Different methods, from group sequential boundaries to flexible alpha spending functions, have been developed to control the overall type I error at prespecified level. These methods mainly apply to testing the same endpoint in multiple interim analyses. In this article, we consider a group sequential design with preplanned endpoint switching after unblinded interim analyses. We extend the alpha spending function method to group sequential stopping boundaries when the parameters can be different between interim, or between interim and final analyses.
|Alternate Journal||J Biopharm Stat|
|Original Publication||Flexible stopping boundaries when changing primary endpoints after unblinded interim analyses.|
|PubMed Central ID||PMC4024106|
|Grant List||P01 ES014635 / ES / NIEHS NIH HHS / United States |
1P01CA142538 / CA / NCI NIH HHS / United States
U54-MD008620 / MD / NIMHD NIH HHS / United States
2P30CA077598 / CA / NCI NIH HHS / United States
P01 CA142538 / CA / NCI NIH HHS / United States
Flexible stopping boundaries when changing primary endpoints after unblinded interim analyses.