Abstract:
:We consider several sources of heterogeneity in a clinical trial with patients' survival time as the main response criterion: differences in prognosis which can be attributed to a latent or ignored prognostic factor; differences in treatment efficacy in subgroups of patients, and differences in treatment combinations received by the patients. The impact of these types of heterogeneity on the treatment comparison is studied assuming a proportional hazards model. It is measured by the size and power of the logrank and proportional hazards score tests and by the bias of the estimated treatment effect. We show that heterogeneity can seriously affect the treatment comparison and has to be considered during the planning stage as well as at the analysis of a clinical trial.
journal_name
Stat Medjournal_title
Statistics in medicineauthors
Schumacher M,Olschewski M,Schmoor Cdoi
10.1002/sim.4780060708subject
Has Abstractpub_date
1987-10-01 00:00:00pages
773-84issue
7eissn
0277-6715issn
1097-0258journal_volume
6pub_type
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