Richard Chin,
Richard (CEO, Oxigene<br>San Francisco, CA, USA) Chin,
Bruce Y Lee,
Bruce Y (University of Pittsburgh<br>Pittsburgh, Pennsylvania, USA) Lee
e.a.
Elsevier Science
e druk, 2008
9780123736956
Principles and Practice of Clinical Trial Medicine
Specificaties
Gebonden, blz.
|
Engels
Elsevier Science |
e druk, 2008
ISBN13: 9780123736956
Rubricering
Levertijd ongeveer 8 werkdagen
Samenvatting
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.
Specificaties
Inhoudsopgave
Section I: Overview <br> <br> Chapter 1 Overview of Clinical Research Medicine<br> <br> Chapter 2 Ethical, Legal, and Regulatory Issues<br> <br><br>Section II: The General Structure of Clinical Trials and Programs<br><br> Chapter 3: Introduction to Clinical Trial Statistics<br> <br> Chapter 4: Measures and Variables<br> <br> Chapter 5: Study Groups<br> <br> Chapter 6: Periods, Sequences, and Trial Design<br> <br><br>Section III: Key Components of Clinical Trials and Programs<br><br> Chapter 7: Endpoints <br> <br> Chapter 8: Economics and Patient Reported Outcomes<br> <br> Chapter 9: Patient Selection and Sampling<br> <br> Chapter 10: Dosing and Intervention<br> <br> Chapter 11: Epidemiology, Decision Analysis, and Simulation <br> <br><br>Section IV: Conduct of the Study <br> <br> Chapter 12: Study Execution<br> <br> Chapter 13: Site Selection and Patient Recruitment <br> <br> <br> <br>Section V: Analysis of Results <br><br> Chapter 14 Assessing Data Quality and Transforming Data<br> <br> Chapter 15 Analysis of Data <br> <br> Chapter 16 Data Interpretation and Conclusions<br> <br><br>Concluding Remarks and Future Directions <br> <br>Appendices <br> Appendix A: FDA Internal Compliance Manuals<br> Appendix B: Medwatch Form <br> Appendix C: Sample Investigator’s Brochure <br> Appendix D: Sample Case Report Form <br> Appendix E: Sample Investigational New Drug Application Form <br> Appendix F: Statement of Investigator Form<br> Appendix G: SAE/SUSAR Initial Report Form