Some Issues of Sample Size Calculation for Time-to-Event Endpoints Using the Freedman and Schoenfeld Formulas

This article deals with seven special issues related to the assumptions, applicability, and practical use of formulas for calculating power or sample size, respectively, for comparative clinical trials with time-to-event endpoints, with particular focus on the well-known Freedman and Schoenfeld meth...

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Bibliographic Details
Published in:Journal of biopharmaceutical statistics 2015-11, Vol.25 (6), p.1285-1311
Main Authors: Abel, Ulrich R., Jensen, Katrin, Karapanagiotou-Schenkel, Irini, Kieser, Meinhard
Format: Article
Language:English
Subjects:
Algorithms
Clinical trials
Clinical Trials as Topic - statistics & numerical data
Comparative analysis
Computer Simulation
Controlled clinical trial
Endpoint Determination - statistics & numerical data
Freedman formula
Humans
Mathematical analysis
Mathematical models
Mathematical problems
Medical research
Models, Statistical
Numerical analysis
Probability
Recommendations
Research Design
Sample Size
Samples
Schoenfeld formula
Statistical analysis
Statistical methods
Statistics
Survival Analysis
Time-to-event data
Treatment Outcome
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Summary:This article deals with seven special issues related to the assumptions, applicability, and practical use of formulas for calculating power or sample size, respectively, for comparative clinical trials with time-to-event endpoints, with particular focus on the well-known Freedman and Schoenfeld methods. All problems addressed are illustrated by numerical examples, and recommendations are given on how to deal with them in the planning of clinical trials.
ISSN:1054-3406
1520-5711
DOI:10.1080/10543406.2014.1000546