Developments in Statistical Evaluation of Clinical Trials

This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials.
Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

Provides an overview of important statistical methods used in 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.