Principles and Practice of Clinical Trial Medicine
Autor Richard Chin, Bruce Y Leeen Limba Engleză Hardback – 24 iul 2008
- Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data
- Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine
- Expert authorship whose experience includes running clinical trials in an academic as well as industry settings
- Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy
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Specificații
ISBN-13: 9780123736956
ISBN-10: 0123736951
Pagini: 560
Dimensiuni: 216 x 276 x 36 mm
Greutate: 1.59 kg
Editura: ELSEVIER SCIENCE
ISBN-10: 0123736951
Pagini: 560
Dimensiuni: 216 x 276 x 36 mm
Greutate: 1.59 kg
Editura: ELSEVIER SCIENCE
Public țintă
Academic, industry, and government researchers in life and biomedical sciencesCuprins
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
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