Design Issues for Randomized Trials

  • David G. Kleinbaum
  • Mitchel Klein
Part of the Statistics for Biology and Health book series (SBH)


In this chapter, we consider issues involved when designing studies with time-to-event outcomes. This includes determining the expected number of events to occur over the study period, the total number of subjects to be recruited into the study, the power of the study, the time period over which to accrue the study subjects, the time period over which enrolled subjects will be followed, and how to adjust sample size requirements to allow for subjects who might be lost to follow-up and/or who might switch therapies from the one they were originally allocated during the study period.


Survival Probability Hazard Rate Median Survival Time Total Sample Size Design Issue 
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Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  1. 1.Department of EpidemiologyRollins School of Public Health at Emory UniversityAtlantaUSA

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