Abstract:
:A method is presented which allows us to adapt the sample size as well as the number and time points of interim analyses to the treatment difference observed at an interim look during the course of a clinical trial with censored survival time as the endpoint. The method allows the inclusion of data inspections during the course of the trial and redesign of the trial on the basis of the observed treatment difference without affecting the type I error risk. Formulae for recalculating the required number of events and the number of further patients to be randomized as a function of the observed hazard rates and the detectable hazard ratio are given.
journal_name
Stat Medjournal_title
Statistics in medicineauthors
Schäfer H,Müller HHdoi
10.1002/sim.1136subject
Has Abstractpub_date
2001-12-30 00:00:00pages
3741-51issue
24eissn
0277-6715issn
1097-0258pii
10.1002/sim.1136journal_volume
20pub_type
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