Statistical Design Monitoring and Analysis of Clinical Trials Principles and Methods 2nd edition by Weichung Joe Shih, Joseph Aisner ISBN 0367772444 978 0367772444

Statistical Design Monitoring and Analysis of Clinical Trials Principles and Methods 2nd edition by Weichung Joe Shih, Joseph Aisner – Ebook PDF Instant Download/Delivery:   0367772444, 978 0367772444
Full download Statistical Design Monitoring and Analysis of Clinical Trials Principles and Methods 2nd edition after payment

Product details: 

ISBN 10: 0367772444

ISBN 13: 9780367772444

Author: Weichung Joe Shih, Joseph Aisner

Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters.

Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations.

This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

Statistical Design Monitoring and Analysis of Clinical Trials Principles and Methods 2nd Table of contents: 

Part 1: Foundations

• Chapter 1: Introduction to Clinical Trials
  • The Importance of Clinical Trials
  • Ethical Considerations in Clinical Research
  • Types of Clinical Trials (Phase I-IV)
  • Regulatory Requirements (e.g., FDA, EMA)
• Chapter 2: Study Design and Planning
  • Randomization and Blinding
  • Study Populations and Inclusion/Exclusion Criteria
  • Outcome Measures and Data Collection
  • Sample Size and Power Calculations

Part 2: Statistical Methods

• Chapter 3: Statistical Inference
  • Hypothesis Testing
  • Confidence Intervals
  • p-values and Statistical Significance
• Chapter 4: Analysis of Variance (ANOVA)
  • One-way ANOVA
  • Two-way ANOVA
  • Repeated Measures ANOVA
• Chapter 5: Regression Analysis
  • Linear Regression
  • Logistic Regression
  • Survival Analysis (Cox Proportional Hazards Model)
• Chapter 6: Sample Size and Power Calculations
  • Methods for Calculating Sample Size
  • Power Considerations
  • Interim Analyses and Group Sequential Designs

Part 3: Monitoring and Data Management

• Chapter 7: Data Safety Monitoring Boards (DSMBs)
  • Role and Responsibilities of DSMBs
  • Safety Monitoring Plans
  • Data Monitoring Committees
• Chapter 8: Data Management and Quality Control
  • Data Collection and Management
  • Data Cleaning and Validation
  • Quality Assurance and Quality Control Procedures

Part 4: Advanced Topics

• Chapter 9: Adaptive Designs
  • Sample Size Re-estimation
  • Treatment Modifications
  • Bayesian Adaptive Designs
• Chapter 10: Biomarkers and Surrogate Endpoints
  • Role of Biomarkers in Clinical Trials
  • Validation of Surrogate Endpoints
• Chapter 11: Missing Data
  • Mechanisms of Missing Data
  • Methods for Handling Missing Data (Imputation, Sensitivity Analyses)

Appendices

• Appendix A: Statistical Tables
• Appendix B: Glossary of Terms
• Appendix C: Case Studies in Clinical Trial Design and Analysis

People also search for Statistical Design Monitoring and Analysis of Clinical Trials Principles and Methods 2nd:

statistical design monitoring and analysis of clinical trials pdf

statistical analysis for meta analysis

statistical data monitoring system

statistical design and analysis

statistical monitoring of clinical trials

Tags:

Weichung Joe Shih,Joseph Aisner,Statistical Design,Clinical Trials