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Clinical Trials
A Methodologic Perspective
Steven Piantadosi
- English
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Clinical Trials
A Methodologic Perspective
Steven Piantadosi
Informazioni sul libro
Presents elements of clinical trial methods that are essential in planning, designing, conducting, analyzing, and interpreting clinical trials with the goal of improving the evidence derived from these important studies
This Third Edition builds on the text's reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials. Readers will encounter the principles of design for various types of clinical trials, and are then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides common sense solutions. All stages of therapeutic development are discussed in detail, and the methods are not restricted to a single clinical application area.
The authors bases current revisions and updates on his own experience, classroom instruction, and feedback from teachers and medical and statistical professionals involved in clinical trials. The Third Edition greatly expands its coverage, ranging from statistical principles to new and provocative topics, including alternative medicine and ethics, middle development, comparative studies, and adaptive designs. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First and Second Editions will discover revamped exercise sets; an updated and extensive reference section; new material on endpoints and the developmental pipeline, among others; and revisions of numerous sections.
In addition, this book:
• Features accessible and broad coverage of statistical design methods—the crucial building blocks of clinical trials and medical research -- now complete with new chapters on overall development, middle development, comparative studies, and adaptive designs
• Teaches readers to design clinical trials that produce valid qualitative results backed by rigorous statistical methods
• Contains an introduction and summary in each chapter to reinforce key points
• Includes discussion questions to stimulate critical thinking and help readers understand how they can apply their newfound knowledge
• Provides extensive references to direct readers to the most recent literature, and there are numerous new or revised exercises throughout the book
Clinical Trials: A Methodologic Perspective, Third Edition is a textbook accessible to advanced undergraduate students in the quantitative sciences, graduate students in public health and the life sciences, physicians training in clinical research methods, and biostatisticians and epidemiologists.
This book is accompanied by downloadable files available below under the DOWNLOADS tab.
These files include:
- MATHEMATICA program – A set of downloadable files that tracks the chapters, containing code pertaining to each.
- SAS PROGRAMS and DATA FILES used in the book.
The following software programs, included in the downloadables, were developed by the author, Steven Piantadosi, M.D., Ph.D:
- RANDOMIZATION – This program generates treatment assignments for a clinical trial using blocked stratified randomization.
- CRM – Implements the continual reassessment methods for dose finding clinical trials.
- OPTIMAL – Calculates two-stage optimal phase II designs using the Simon method.
- POWER – This is a power and sample size program for clinical trials.
Executables for installing these programs can also be found at https://risccweb.csmc.edu/biostats/.
Steven Piantadosi, MD, PhD, is the Phase One Foundation Distinguished Chair and Director of the Samuel Oschin Cancer Institute, and Professor of Medicine at Cedars-Sinai Medical Center in Los Angeles, California. Dr. Piantadosi is one of the world's leading experts in the design and analysis of clinical trials for cancer research. He has taught clinical trials methods extensively in formal courses and short venues. He has advised numerous academic programs and collaborations nationally regarding clinical trial design and conduct, and has served on external advisory boards for the National Institutes of Health and other prominent cancer programs and centers. The author of more than 260 peer-reviewed scientific articles, Dr. Piantadosi has published extensively on research results, clinical applications, and trial methodology. While his papers have contributed to many areas of oncology, he has also collaborated on diverse studies outside oncology including lung disease and degenerative neurological disease.
Domande frequenti
Informazioni
1
Preliminaries
1.1 Introduction
1.2 Audiences
Indice dei contenuti
- Cover
- Wiley Series in Probability and Statistics
- Title Page
- Copyright
- Preface to the Third Edition
- 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: The Trial Cohort
- 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: Sample Size and Power
- Chapter 17: Treatment Allocation
- Chapter 18: Treatment Effects Monitoring
- Chapter 19: Counting Subjects and Events
- Chapter 20: Estimating Clinical Effects
- Chapter 21: Prognostic Factor Analyses
- Chapter 22: Factorial Designs
- Chapter 23: Crossover Designs
- Chapter 24: Meta-Analyses
- Chapter 25: Reporting and Authorship
- Chapter 26: Misconduct and Fraud in Clinical Research
- Appendix A: Data and Programs
- Appendix B: Abbreviations
- Appendix C: Notation and Terminology
- Appendix D: Nuremberg Code
- References
- Index
- End User License Agreement