Readership
Academic, industry, and government researchers in life and biomedical sciences
Principles and Practice of Clinical Trial Medicine, 1st Edition
Print Book
Release Date: 25 Jul 2008
Imprint: Academic Press
ISBN: 9780123736956
Pages: 560
Dimensions: 276 X 216
A concise overview of the essential aspects of clinical research and trial design. Presents the principles and practical details needed to design, conduct, and interpret the results on clinical trials, as well as how to take a drug from initial development to approval stage.
Recent Publication
Recent Publication
Principles and Practice of Clinical Trial Medicine, 1st Edition
Section I: OverviewChapter 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
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Principles and Practice of Clinical Trial Medicine
