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About this book
Comprehensive resource presenting methods essential in planning, designing, conducting, analyzing, and interpreting clinical trials
The Fourth Edition of Clinical Trials builds on the text's reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials, discussing principles of design for various types of clinical trials and elements of planning the experiment, assembling a study cohort, assessing data, and reporting results.
Each chapter contains an introduction and summary to reinforce key points. Discussion questions stimulate critical thinking and help readers understand how they can apply their newfound knowledge.
Written by a highly qualified author with significant experience in the field, the Fourth Edition of Clinical Trials approaches the topic with:
- Problems that may arise during a trial, and accompanying common sense solutions
- Design alternatives for addressing many questions in therapeutic development
- Statistical principles with new and provocative topics, such as generalizing results, operating characteristics, trial issues during the COVID-19 pandemic, and more
- Alternative medicine, ethics, middle development, comparative studies, adaptive designs, and clinical trials using point of care data
- Revamped exercise sets, updated and extensive references, new material on endpoints and the developmental pipeline, and revisions of numerous sections, tables, and figures
Standing out due to its accessible and broad coverage of statistical design methods which are the building blocks of clinical trials and medical research, Clinical Trials is an essential learning aid on the subject for undergraduate and graduate clinical trials courses.
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Information
Table of contents
- Cover
- Title Page
- Copyright
- Contents
- Preface
- About the Companion Website
- Chapter 1 Preliminaries
- Chapter 2 Clinical Trials as Research
- Chapter 3 Why Clinical Trials Are Ethical
- Chapter 4 Contexts for Clinical Trials
- Chapter 5 Measurement
- Chapter 6 Random Error and Bias
- Chapter 7 Statistical Perspectives
- Chapter 8 Experiment Design in Clinical Trials
- Chapter 9 Trial Cohorts
- Chapter 10 Development Paradigms
- Chapter 11 Translational Clinical Trials
- Chapter 12 Early Development and Dose Finding
- Chapter 13 Middle Development
- Chapter 14 Comparative Trials
- Chapter 15 Adaptive Design Features
- Chapter 16 Precision, Sample Size, and Power
- Chapter 17 Treatment Allocation
- Chapter 18 Monitoring Treatment Effects
- Chapter 19 Counting Subjects and Events
- Chapter 20 Estimating Clinical Effects
- Chapter 21 Generalizing Results From Clinical Trials
- Chapter 22 Prognostic Factor Analyses
- Chapter 23 Factorial Designs
- Chapter 24 Crossover Designs
- Chapter 25 Operating Characteristics
- Chapter 26 Meta‐Analyses
- Chapter 27 Reporting and Authorship
- Chapter 28 Misconduct and Fraud in Clinical Research
- Chapter 29 Clinical Trials in the COVID‐19 Pandemic
- Chapter 30 Real‐World Clinical Trials
- Appendix A Notation and Terminology
- References
- Index
- EULA