TY - BOOK AU - Harrington,Robert A. AU - Lopes,Renato D. TI - Understanding clinical research T2 - McGraw-Hill's AccessMedicine SN - 0071746781 (printISBN) AV - R853.C55 U53 2013 U1 - 610.72/4 23 PY - 2013/// CY - New York, N.Y. : PB - McGraw-Hill Education LLC., KW - Clinical medicine KW - Research KW - Clinical trials KW - Biomedical Research KW - Clinical Trials as Topic KW - Research Design N1 - 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; Also issued in Online and PDF version N2 - 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 UR - http://accessmedicine.mhmedical.com/book.aspx?bookid=674 ER -