Principles and Practice of Clinical Trial Medicine

able 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