Understanding clinical research

Understanding clinical research [electronic resource] / Understanding clinical research, editors, Renato D. Lopes, editor, Robert A. Harrington. - 1st ed. - New York, N.Y. : McGraw-Hill Education LLC., c2013. - xvi, 245 p. : ill., figs., tables. - McGraw-Hill's AccessMedicine . - McGraw-Hill's AccessMedicine. .

Includes bibliographical references and indexes.

Section I. Evolution of Clinical Research -- Chapter 1. A Brief History of Clinical Trials, Drug Regulations, and the Food and Drug Administration -- Chapter 2. Information Technology, Access, ClinicalTrials.gov -- Chapter 3. The Role of Academic Research Organizations in Clinical Research -- Chapter 4. Ethics of Clinical Research: An Overview and Emerging Issues -- Section II. Principles of Clinical Experimentation -- Chapter 5. Introduction to Clinical Experimentation -- Chapter 6. Phase I Trials: First in Human -- Chapter 7. Phase II Clinical Trials -- Chapter 8. Phase III and IV Clinical Trials -- Chapter 9. Challenges of Clinical Trials in Pediatrics -- Section III. Observational Research -- Chapter 10. Observational Research -- Chapter 11. Data Resources -- Chapter 12. Observational Study Designs -- Chapter 13. Challenges of Observational Designs -- Chapter 14. Specific Regression Techniques -- Chapter 15. Analytical Methods of Addressing Confounding -- Chapter 16. Lessons from Notable Examples in Observational Research.

Complete how-to guidance on conducting clinical research, this book addresses the operational challenges of clinical trials and provides a clear explanation of the methodologies necessary to interpret results. The book addresses all aspects of clinical trials, from design and implementation to statistics to regulatory scrutiny. A resource for students, residents, and clinicians who need a working knowledge of clinical research principles. The chapter authors are all leaders in the field and engaged in cutting edge clinical research. Use as a textbook, as a reference, and as a course guide for mandated clinical research training courses.



0071746781 (printISBN) 0071792651 (e-ISBN) 1299825915 9780071746786 (print-ISBN) 9780071792653 (e-ISBN) 9781299825918

2012051271


Clinical medicine --Research.
Clinical trials.
Biomedical Research.
Clinical Trials as Topic.
Research Design.

R853.C55 / U53 2013

610.72/4

W 20.5 / U545 2013
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