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Design and Analysis of Clinical Trials Concepts and Methodologies

ISBN-10: 0470887656
ISBN-13: 9780470887653
Edition: 3rd 2013
List price: $128.00
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Description: Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions. These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. The purpose of this  More...

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Book details

List price: $128.00
Edition: 3rd
Copyright year: 2013
Publisher: John Wiley & Sons, Limited
Publication date: 1/3/2014
Binding: Hardcover
Pages: 892
Size: 7.25" wide x 10.25" long x 2.00" tall
Weight: 3.630
Language: English

Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions. These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. The purpose of this clinical trials book is to provide a comprehensive and unified presentation of designs and analyses utilized at different stages of clinical research and development. It incorporates actual clinical trials in order to feature everyday applicability and explains concepts through illustrations and numerous real examples from clinical trials

Preface
Preliminaries
Introduction
What are Clinical Trials?
History of Clinical Trials
Regulatory Process and Requirements
Investigational New Drug Application
New Drug Application
Clinical Development and Practice
ATMS and Structure of the Book
Basic Statistical Concepts
Introduction
Uncertainty and Probability
Bias and Variability
Confounding and Interaction
Descriptive and Inferential Statistics
Hypotheses Testing and p-Values
Clinical Significance and Clinical Equivalence
Reproducibility and Generalizability
Basic Design Considerations
Introduction
Goals of Clinical Trials
Target Population and Patient Selection
Selection of Controls
Statistical Considerations
Other Issues
Discussion
Randomization and Blinding
Introduction
Randomization Models
Randomization Methods
Implementation of Randomization
Generalization of Controlled Randomized Trials
Blinding
Discussion
Designs and their Classifications
Designs for Clinical Trials
Introduction
Parallel Group Designs
Clustered Randomized Designs
Crossover Designs
Titration Designs
Enrichment Designs
Group Sequential Designs
Placebo-Challenging Designs
Blinded Reader Designs
Discussion
Designs for Cancer Clinical Trials
Introduction
General Considerations for Phase I Cancer Clinical Trials
Single-Stage Up-and-Down Phase I Designs
Two-Stage Up-and-Down Phase I Designs
Continual Reassessment Method Phase I Designs
Optimal and Flexible Multiple-Stage Designs
Randomized Phase II Designs
Discussion
Classification of Clinical Trials
Introduction
Multicenter Trials
Superiority Trials
Active Control and Equivalence/Noninferiority Trials
Dose-Response Trials
Combination Trials
Bridging Studies and Global Trials
Vaccine Clinical Trials
QT Studies
Discussion
Analysis of Clinical Data
Analysis of Continuous Data
Introduction
Estimation
Test Statistics
Analysis of Variance
Analysis of Covariance
Nonparametric Methods
Repeated Measures
Discussion
Analysis of Categorical Data
Introduction
Statistical Inference for One Sample
Inference of Independent Samples
Ordered Categorical Data
Combining Categorical Data
Model-Based Methods
Repeated Categorical Data
Discussion
Censored Data and Interim Analysis
Introduction
Estimation of the Survival Function
Comparison Between Survival Functions
Cox's Proportional Hazard Model
Calendar Time and Information Time
Group Sequential Methods
Discussion
Sample Size Determination
Introduction
Basic Concept
Two Samples
Multiple Samples
Censored Data
Dose-Response Studies
Crossover Designs
Equivalence and Noninferiority Trials
Multiple-Stage Design in Cancer Trials
Multinational Trials
Comparing Variabilities
Discussion
Issues in Evaluation
Issues in Efficacy Evaluation
Introduction
Baseline Comparison
Intention-to-Treat Principle and Efficacy Analysis
Adjustment for Covariates
Multicenter Trials
Multiplicity
Data Monitoring
Use of Genetic Information for Evaluation of Efficacy
Sample Size Reestimation
Discussion
Safety Assessment
Introduction
Extent of Exposure
Coding of Adverse Events
Analysis of Adverse Events
Analysis of Laboratory Data
Analysis of QT/QTc Prolongation
Discussion
Recent Development
Biomarkers and Targeted Clinical Trials
Introduction
Concepts and Strategies
Biomarker Development and Validation
Designs of Targeted Clinical Trials
Analyses of Targeted Clinical Trials
Discussion
Trials for Evaluating Accuracy of Diagnostic Devices
Introduction
Study Design
Measures of Diagnostic Accuracy
Reporting Results
Sample Size Estimation
Discussion
Statistical Methods in Translational Medicine
Introduction
Biomarker Development
Bench-to-Bedside
Animal Model Versus Human Model
Translation in Study Endpoints
Bridging Studies
Discussion
Appendix
Adaptive Clinical Trial Designs
Introduction
What Is Adaptive Design?
Well-Understood and Less Well-Understood Designs
Clinical/Statistical and Regulatory Perspectives
Impact of Protocol Amendments
Challenges in By-Design Adaptations
Obstacles of Retrospective Adaptations
Discussion
Traditional Chinese Medicine
Introduction
Fundamental Differences
Basic Considerations of TCM Clinical Trials
Other Issues in TCM Research and Development
Consortium for Globalization of Traditional Chinese Medicine
Discussion
Conduct of Clinical Trials
Preparation and Implementation of a Clinical Protocol
Introduction
Structure and Components of a Protocol
Points to be Considered and Common Pitfalls During Development and Preparation of a Protocol
Common Departures for Implementation of a Protocol
Monitoring, Audit, and Inspection
Quality Assessment of a Clinical Trial
Discussion
Data Management of a Clinical Trial
Introduction
Regulatory Requirements
Development of Case Report Forms
Database Development
Data Entry, Query, and Correction
Data Validation and Quality
Database Lock, Archive, and Transfer
Critical Issues
References
Appendix A
Index

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