Concern over the safety and efficacy of drug therapy is a significant issue worldwide. Clinical trials are scientific investigations that examine and evaluate the safety and efficacy of drug therapy. Balancing statistical and clinical aspects with a focus on interactions among clinical scientists, this important resource covers issues that may arise during the various phases throughout pharmaceutical research and development. The Second Edition takes into consideration the rapid development in design and analysis in clinical research over the past five years, including, but not limited to, the many changes in technology and the regulatory environment.…mehr
Concern over the safety and efficacy of drug therapy is a significant issue worldwide. Clinical trials are scientific investigations that examine and evaluate the safety and efficacy of drug therapy. Balancing statistical and clinical aspects with a focus on interactions among clinical scientists, this important resource covers issues that may arise during the various phases throughout pharmaceutical research and development. The Second Edition takes into consideration the rapid development in design and analysis in clinical research over the past five years, including, but not limited to, the many changes in technology and the regulatory environment.
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Autorenporträt
S.-C. Chow, Millennium Pharmaceuticals, Inc., Cambridge, MA; J.-P. Liu, National Cheng-kung Univ., Tainan, Taiwan and National Health Research Institutes, Taipei, Taiwan
SHEIN-CHUNG CHOW, PhD, is currently Vice President of Biostatistics and Clinical Data Management for Millennium Pharmaceuticals, Inc., in Cambridge, Massachusetts. JEN-PEI LIU, PhD, is currently Professor of Statistics for the National Cheng kung University in Tainan, Taiwan, and an investigator for the National Health Research Institutes in Taipei, Taiwan. Both authors have extensive background experience in industry and academia, and, collectively, have published well over a dozen books in their respective fields of study.
Inhaltsangabe
- Preface
- Preface to the First Edition
1. Introduction
2. Basic Statistical Concepts
3. Basic Design Considerations
4. Randomization and Blinding
5. Designs for Clinical Trials
6. Designs for Cancer Clinical Trials
7. Classification of Clinical Trials
8. Analysis of Continuous Data
9. Analysis of Categorical Data
10. Censored Data and Interim Analysis
11. Sample Size Determination
12. Issues in Efficacy Evaluation
13. Safety Assessment
14. Preparation and Implementation of a Clinical Protocol
