PLANNING FOR PRECISION IN SURVIVAL STUDIES

If the purpose of a clinical study is not only to test the null hypothesis but also to estimate the magnitude of the treatment effect, the study design should ensure not only that the study will have adequate power but also that it will enable the researcher to report the relevant parameters with an appropriate level of precision. This paper discusses the factors that control precision in survival studies and shows how a computer program may be used to address these issues. The program allows the user to systematically modify assumptions about the population (e.g. the magnitude of the hazard ratio or the attrition rate) and elements of the study design (e.g. sample size and trial duration), quickly identify the impact of these factors on the study's precision, and modify the study design accordingly. The program may also be used to compute power for a planned study, and confidence intervals for a completed study.