Developments in Statistical Evaluation of Clinical Trials

• Preface.- List of contributors.- 1.Statistical Models and Methods for Incomplete Data in Randomized Clinical Trials. M.A. McIsaac and R.J. Cook.- 2.Bayesian Decision Theory and the Design and Analysis of Randomized Clinical Trials. A.R. Willan.- 3.Designing Multi-Arm Multi-Stage Clinical Studies. T.Jaki.- 4.Statistical Approaches to Improving Trial Efficiency and Conduct. J.Pogue, P. J. Devereaux and S.Yusuf.- 5.Competing Risk and Survival Analysis. K.van Montfort, P.Fennema and W.Ghidey.- 6.Recent Developments in Group-Sequential Designs. J.M. S. Wason.- 7.Statistical Inference for Non-Inferiority of a Diagnostic Procedure Compared to an Alternative Procedure, Based on the Difference in Correlated Proportions from Multiple Raters. H.Saeki and T.Tango.- 8.Design and Analysis of Clinical Trial Simulations. K.Kuribayashi.- 9.Causal Effect Estimation and Dose Adjustment in Exposure-Response Relationship Analysis. J.Wang.- 10.Different Methods to Analyse Results of a Randomised Controlled Trial with More Than one Follow-up Measurement. J.W. R. Twisk.- 11.Statistical Methods for the Assessment of Clinical Relevance. M.Kieser.- 12.Statistical Considerations in the Use of Composite Endpoints in Time to Event Analyses. R.J. Cook and K.-A.Lee.- 13.Statistical Validation of Surrogate Markers in Clinical Trials. A.Alonso, G.Molenberghs and G.van Breukelen.- 14.Biomarker-Based Designs of Phase III Clinical Trials for Personalized Medicine. S.Matsui, T.Nonaka and Y.Choai.- 15.Dose-Finding Models for Two-Agent Combination Phase I Trials. A.Hirakawa and S.Matsui.- 16.Multi-State Models Used in Oncology Trials. B.Gaschler-Markefski, K.Schiefele, J.Hocke and F.Fleischer.- 17.Review of Designs for Accommodating Patients’ or Physicians’ Preferences in Randomized Controlled Trials. A.S. Ismaila and S.D. Walter.- 18.Dose Finding Methods in Oncology: From the Maximum Tolerated Dose to the Recommended Phase II Dose. X.Paoletti and A.Doussau.

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