| Description |
xvi, 245 pages : illustrations ; 23 cm |
| Contents |
A brief history of clinical trials, drug regulations, and the Food and Drug Administration / Nidhi Tripathy ... [et al.] -- Information technology, access, clinicaltrials.gov / Anjan Chakrabarti and C. Michael Gibson -- The role of academic research organizations in clinical research / Craig J. Reist ... [et al.] -- Ethics of clinical research : an overview and emerging issues / Yee Weng Wong and Kevin A. Schulman -- Introduction to clinical experimentation / Robert Bigelow -- Phase I trials : first in human / Kevin M. Watt, Karen Chiswell, and Michael Cohen-Wolkoweiz -- Phase II clinical trials / Jeffrey T. Guptill and Karen Chiswell -- Phase III and IV clinical trials / Gail E. Hafley, Sergio Leonardi, and Karen S. Pieper -- Challenges of clinical trials in pediatrics / Kevin N. Turner and P. Brian Smith -- Observational research / Michaela Dinan -- Data resources / Ying Xian -- Observational study designs / Bradley G. Hammill -- Challenges of observational designs / David M. Vock -- Specific regression techniques / Phillip J. Schulte -- Analytical methods of addressing confounding / Eric M. Reyes -- Lessons from notable examples in observational research / Zubin Eapen |
| Summary |
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 |
| Bibliography |
Includes bibliographical references and index |
| Subject |
Clinical trials.
|
|
Clinical medicine -- Research.
|
|
Biomedical Research.
|
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Clinical Trials as Topic.
|
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Research Design.
|
| Author |
Lopes, Renato D.
|
|
Harrington, Robert A.
|
| LC no. |
2012051271 |
| ISBN |
9780071746786 (paperback: acid-free paper) |
|
0071746781 |
|
