Principles and Practice of Clinical Trial Medicine

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.

Richard Chin (Author), Bruce Y Lee (Author)

9780123736956, Elsevier Science

Hardback, published 25 July 2008

560 pages
27.6 x 21.5 x 3.2 cm, 1.53 kg

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.

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

Subject Areas: Pharmacology [MMG], Clinical & internal medicine [MJ], Clinical trials [MBGR1]