Principles and Practice of Clinical Trial Medicine (Hardcover, 1st)

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