Full 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.
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
