Developments in Statistical Evaluation of Clinical Trials

✍ Scribed by Kees van Montfort, Johan Oud, Wendimagegn Ghidey (eds.)

Publisher: Springer-Verlag Berlin Heidelberg
Year: 2014
Tongue: English
Leaves: 364
Edition: 1
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

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.

✦ Table of Contents

Front Matter....Pages i-xi
Statistical Models and Methods for Incomplete Data in Randomized Clinical Trials....Pages 1-27
Bayesian Decision Theory and the Design and Analysis of Randomized Clinical Trials....Pages 29-50
Designing Multi-arm Multi-stage Clinical Studies....Pages 51-69
Statistical Approaches to Improving Trial Efficiency and Conduct....Pages 71-84
Competing Risks and Survival Analysis....Pages 85-96
Recent Developments in Group-Sequential Designs....Pages 97-118
Statistical Inference for Non-inferiority of a Diagnostic Procedure Compared to an Alternative Procedure, Based on the Difference in Correlated Proportions from Multiple Raters....Pages 119-137
Design and Analysis of Clinical Trial Simulations....Pages 139-151
Causal Effect Estimation and Dose Adjustment in Exposure-Response Relationship Analysis....Pages 153-175
Different Methods to Analyse the Results of a Randomized Controlled Trial with More Than One Follow-Up Measurement....Pages 177-193
Statistical Methods for the Assessment of Clinical Relevance....Pages 195-207
Statistical Considerations in the Use of Composite Endpoints in Time to Event Analyses....Pages 209-226
Statistical Validation of Surrogate Markers in Clinical Trials....Pages 227-246
Biomarker-Based Designs of Phase III Clinical Trials for Personalized Medicine....Pages 247-263
Dose-Finding Methods for Two-Agent Combination Phase I Trials....Pages 265-282
Multi-state Models Used in Oncology Trials....Pages 283-304
Review of Designs for Accommodating Patients’ or Physicians’ Preferences in Randomized Controlled Trials....Pages 305-333
Dose Finding Methods in Oncology: From the Maximum Tolerated Dose to the Recommended Phase II Dose....Pages 335-361

✦ Subjects

Statistical Theory and Methods; Statistics for Life Sciences, Medicine, Health Sciences; Biostatistics

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