Principles and Practice of Clinical Trial Medicine

Erscheinungsjahr 2008
ISBN: 978-0-12-373695-6
Verlag: Elsevier Inc

Buch, Englisch, 560 Seiten, Format (B × H): 219 mm x 277 mm, Gewicht: 1465 g

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, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results.

Zielgruppe

Academic, industry, and government researchers in life and biomedical sciences

Autoren/Hrsg.

Chin, Richard

Lee, Bruce Y

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Klinische und Innere Medizin

Inhaltsverzeichnis

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

Über Autor(innen)

Chin, Richard
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.

Lee, Bruce Y
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.

Dr. Chin is a Harvard trained, Board Certified internist with drug development across a wide range of specialties, including oncology, immunology, ophthalmology, neurology, endocrinology, cardiovascular medicine, among others. He has been responsible for over 40 Investigational New Drug (IND) Applications and eight New Drug Applications (NDAs) / Biologic License Applications (BLAs). Some of the drugs Dr. Chin has overseen include ranibizumab , natalizumab, tenecteplase, Bapineuzumab, ziconotide, and omalizumab, He has both U.S. and international experience, and has overseen a wide variety of functions, including Clinical Development, Regulatory, Biostatistics, Quality Assurance/Compliance, Chemistry Manufacturing and Control, Safety and Medical Affairs. Dr. Chin's is currently President and CEO of Oxigene, a biotechnology company. Previously, he was Senior Vice President and Head of Global Development for Elan Corporation, and before that served as the Head of Clinical Research for the Biotherapeutics Unit at Genentech. Dr. Chin holds a Medical Degree from Harvard Medical School. He received the equivalent of a J.D. with honors from Oxford University, England under a Rhodes Scholarship. He graduated with a Bachelor of Arts in Biology, magna cum laude, from Harvard University. He previously served on the adjunct clinical faculty at Stanford Medical School. 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.