Principles and Practice of Clinical Trial Medicine


  • Richard Chin, CEO, Oxigene San Francisco, CA, USA
  • Bruce Lee, University of Pittsburgh Pittsburgh, Pennsylvania, USA

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


Book information

  • Published: June 2008
  • ISBN: 978-0-12-373695-6

Table of Contents

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