Clinical trials with correlated response data based on generalized estimating equations (GEE) have become increasingly popular as they require smaller samples than classical methods that ignore the clustered nature of the data. We have recently derived the recommendation to use the independence estimating equations (IEE) as primary analysis in most controlled clinical trials instead of GEE with estimated correlations. Although several approaches for sample size and power calculation have been proposed, we have shown that most of these procedures are very specific and not as general as required for designing clinical trials.
Institut für Medizinische Biometrie und Statistik, Universität zu Lübeck, Ratzeburger Allee 160, Haus 4, 23538 Lübeck, Germany. dahmen@imbs.uni-luebeck.de