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Informationen zum Autor Mark Chang, PHD, is a Scientific Fellow at Millennium Pharmaceuticals. He has extensive experience with IND and NDA submissions. His involvement in drug development includes both strategic and methodological aspects. Dr. Chang is an Associate Editor for the Journal of Biopharmaceutical Statistics . Klappentext ExpDesign Studio facilitates more efficient clinical trial designThis book introduces pharmaceutical statisticians, scientists, researchers, and others to ExpDesign Studio software for classical and adaptive designs of clinical trials. It includes the Professional Version 5.0 of ExpDesign Studio software that frees pharmaceutical professionals to focus on drug development and related challenges while the software handles the essential calculations and computations. After a hands-on introduction to the software and an overview of clinical trial designs encompassing numerous variations, Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio:* Covers both classical and adaptive clinical trial designs, monitoring, and analyses* Explains various classical and adaptive designs including group sequential, sample-size reestimation, dropping-loser, biomarker-adaptive, and response-adaptive randomization designs* Includes instructions for over 100 design methods that have been implemented in ExpDesign Studio and step-by-step demos as well as real-world examples* Emphasizes applications, yet covers key mathematical formulations* Introduces readers to additional toolkits in ExpDesign Studio that help in designing, monitoring, and analyzing trials, such as the adaptive monitor, graphical calculator, the probability calculator, the confidence interval calculator, and more* Presents comprehensive technique notes for sample-size calculation methods, grouped by the number of arms, the trial endpoint, and the analysis basisWritten with practitioners in mind, this is an ideal self-study guide for not only statisticians, but also scientists, researchers, and professionals in the pharmaceutical industry, contract research organizations (CROs), and regulatory bodies. It's also a go-to reference for biostatisticians, pharmacokinetic specialists, and principal investigators involved in clinical trials. Zusammenfassung This book with CD-ROM introduces the Software ExpDesign Studio for classic and adaptive designs and computer simulations. The book includes step-by-step demos on creating various trial designs, using the automatic outputs to optimize the trial design, and monitoring a clinical trial in progress. Inhaltsverzeichnis Preface. Self-Study and Practice Guide. 1 ExpDesign Studio. 1.1 Introduction. 1.2 How to Design a Trial Using ExpDesign Studio. 1.2.1 How to Design a Classical Trial. 1.2.2 How to Design a Group Sequential Trial. 1.2.3 How to Design an Adaptive Trial. 1.2.4 How to Run Adaptive Trial Simulations. 1.2.5 How to Design a Multistage Trial. 1.2.6 How to Design a Dose-Escalation Trial. 1.3 ExpDesign Menus. 2 Clinical Trial Design. 2.1 Introduction. 2.2 Classical Clinical Trial Design. 2.2.1 Substantial Evidence. 2.2.2 Clinical Trial Endpoint. 2.2.3 Confirmatory Trials. 2.2.4 Exploratory Trials. 2.2.5 Multicenter Trials. 2.2.6 Trials to Show Superiority. 2.2.7 Trials to Show Equivalence or Noninferiority. 2.2.8 Trials to Show a Dose-Response Relationship. 2.2.9 Parallel Design. 2.2.10 Crossover Design. 2.2.11 Factorial Design. 2.3 Selection of a Trial Design. 2.3.1 Balanced Versus Unbalanced Designs. 2.3.2 Crossover Versus Parallel Designs. 2.3.3 Dose Escalation Versus Titration Designs. 2.3.4 Bioavailability Versus Bioequivalence Designs. 2.3.5 Equivalence Versus Bioequivalence. 2.3.6 ...
