
Principles and Practice of Clinical Trial Medicine
- 1st Edition - June 18, 2008
- Imprint: Academic Press
- Authors: Richard Chin, Bruce Y Lee
- Language: English
- Hardback ISBN:9 7 8 - 0 - 1 2 - 3 7 3 6 9 5 - 6
- eBook ISBN:9 7 8 - 0 - 0 8 - 0 5 5 7 9 3 - 9
Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics… Read more

Purchase options

Institutional subscription on ScienceDirect
Request a sales quote- Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data
- Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine
- Expert authorship whose experience includes running clinical trials in an academic as well as industry settings
- Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy
Chapter 1 Overview of Clinical Research Medicine
Chapter 2 Ethical, Legal, and Regulatory Issues
Section II: The General Structure of Clinical Trials and Programs
Chapter 3: Introduction to Clinical Trial Statistics
Chapter 4: Measures and Variables
Chapter 5: Study Groups
Chapter 6: Periods, Sequences, and Trial Design
Section III: Key Components of Clinical Trials and Programs
Chapter 7: Endpoints
Chapter 8: Economics and Patient Reported Outcomes
Chapter 9: Patient Selection and Sampling
Chapter 10: Dosing and Intervention
Chapter 11: Epidemiology, Decision Analysis, and Simulation
Section IV: Conduct of the Study
Chapter 12: Study Execution
Chapter 13: Site Selection and Patient Recruitment
Section V: Analysis of Results
Chapter 14 Assessing Data Quality and Transforming Data
Chapter 15 Analysis of Data
Chapter 16 Data Interpretation and Conclusions
Concluding Remarks and Future Directions
Appendices
Appendix A: FDA Internal Compliance Manuals
Appendix B: Medwatch Form
Appendix C: Sample Investigator’s Brochure
Appendix D: Sample Case Report Form
Appendix E: Sample Investigational New Drug Application Form
Appendix F: Statement of Investigator Form
Appendix G: SAE/SUSAR Initial Report Form
- Edition: 1
- Published: June 18, 2008
- Imprint: Academic Press
- No. of pages: 560
- Language: English
- Hardback ISBN: 9780123736956
- eBook ISBN: 9780080557939
RC
Richard Chin
BL
Bruce Y Lee
His previous positions include serving as Senior Manager at Quintiles Transnational, working in biotechnology equity research at Montgomery Securities, and co-founding Integrigen, a biotechnology company. His consulting experience includes a large variety of clients, ranging from large and small pharmaceutical, biotechnology, and medical device companies.
Dr. Lee has authored three books, as well as numerous research publications, review articles, and book chapters.
Dr. Lee received his B.A. from Harvard University, M.D. from Harvard Medical School, and M.B.A. from the Stanford Graduate School of Business. He is board-certified in Internal Medicine, having completed his residency training at the University of California, San Diego.