Principles and Practice of Clinical Trial Medicine

Section I: Overview

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

Richard Chin is the CEO of Institute for OneWorld Health, the first U.S. nonprofit pharmaceutical company and Associate Professor at UCSF School of Medicine. OneWorld Health develops affordable drugs for neglected patients in the developing world. Dr. Chin has extensive expertise in drug development, including over 45 INDs and almost a dozen drug registrations. His previous roles include CEO of a NASDAQ listed company, Senior Vice President of Global Development at Elan, and Head of Clinical Research for the Biotherapeutics Unit at Genentech. He was named by Businessweek in 2006 as one of the youngest 99 public company CEOs in the United States. Dr. Chin earned an M.D. from Harvard and the equivalent of a J.D. from Oxford, where he studied as a Rhodes Scholar. Dr. Lee is currently an Assistant Professor of Medicine and Biomedical Informatics at the University of Pittsburgh. He is also Core Faculty in the Section for Decision Sciences and Clinical Systems Modeling, the Center for Research in Health Care, and the RAND-University of Pittsburgh Health Institute. He is a Co-Investigator for the National Institutes of Health (NIH) Modeling of Infectious Diseases Agent Study (MIDAS) research and informatics network.



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.