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 of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, this book covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results.
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
Academic, industry, and government researchers in life and biomedical sciences
Section I: OverviewChapter 1 Overview of Clinical Research Medicine Chapter 2 Ethical, Legal, and Regulatory Issues
Section II: The General Structure of Clinical Trials and ProgramsChapter 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 ProgramsChapter 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 StudyChapter 12: Study Execution Chapter 13: Site Selection and Patient Recruitment
Section V: Analysis of ResultsChapter 14 Assessing Data Quality and Transforming Data Chapter 15 Analysis of Data Chapter 16 Data Interpretation and Conclusions
Concluding Remarks and Future Directions
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
- No. of pages:
- © Academic Press 2008
- 18th June 2008
- Academic Press
- eBook ISBN:
- Hardcover ISBN:
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.
CEO, Oxigene San Francisco, CA, USA
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.
University of Pittsburgh Pittsburgh, Pennsylvania, USA