Principles and Practice of Clinical Trial Medicine

著者名：Chin, Richard/Lee, Bruce Y

Academic Press（2008/07/25発売）

• 言語：ENG
• ISBN：9780123736956
• eISBN：9780080557939

Description

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.- 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

Table of Contents

Section I: OverviewChapter 1 Overview of Clinical Research MedicineChapter 2 Ethical, Legal, and Regulatory IssuesSection II: The General Structure of Clinical Trials and ProgramsChapter 3: Introduction to Clinical Trial StatisticsChapter 4: Measures and Variables Chapter 5: Study GroupsChapter 6: Periods, Sequences, and Trial DesignSection III: Key Components of Clinical Trials and ProgramsChapter 7: EndpointsChapter 8: Economics and Patient Reported Outcomes Chapter 9: Patient Selection and SamplingChapter 10: Dosing and InterventionChapter 11: Epidemiology, Decision Analysis, and SimulationSection IV: Conduct of the Study Chapter 12: Study ExecutionChapter 13: Site Selection and Patient Recruitment Section V: Analysis of Results Chapter 14 Assessing Data Quality and Transforming DataChapter 15 Analysis of DataChapter 16 Data Interpretation and ConclusionsConcluding Remarks and Future Directions Appendices Appendix A: FDA Internal Compliance ManualsAppendix 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 FormAppendix G: SAE/SUSAR Initial Report Form