Principles and Practice of Clinical Research

Principles and Practice of Clinical Research

3.77 (9 ratings by Goodreads)
  • Hardback
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"Principles and Practice of Clinical Research" is a comprehensive text which addresses the theoretical and practical issues involved in conducting clinical research. This book is divided into three parts: ethical, regulatory, and legal issues; biostatistics and epidemiology; technology transfer, protocol development and funding. It is designed to fill a void in clinical research education and provides the necessary fundamentals for clinical investigators. It should be of particular benefit to all individuals engaged in clinical research, whether as physician or dental investigators, Ph.D. basic scientists, or members of the allied health professions, as well as both students and those actively participating in clinical research. It includes comprehensive review ranging from a historical perspective to the current ethical, legal and social issues and an introduction to biostatistics and epidemiology. It is a practical guide to writing a protocol, getting funding for clinical research, preparing images for publication and display. It is a cohesive and clear presentation by authors carefully selected to teach a very popular course at NIH.
It is an excellent companion text for courses on clinical research.
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Product details

  • Hardback | 490 pages
  • 213.4 x 276.9 x 27.9mm | 1,474.19g
  • Academic Press Inc
  • San Diego, United States
  • illustrations facsimiles, forms, portraits
  • 0122740653
  • 9780122740657

Table of contents

Preface. Acknowledgements. Historical Perspective and Introduction. Part I: Ethical, Regulatory and Legal Issues Ethical Principles in Clinical Research. Researching a Bioethical Question. Integrity in Research: Individual and Institutional Responsibility. Institutional Review Boards. Data and Safety Monitoring Boards. Data and Data Management in Clinical Trials. Unanticipated Risk in Clinical Research. The Regulation of Drugs and Biological Products by the Food and Drug Administration. Legal Issues. NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research. Part II: Biostatistics and Epidemiology An Introduction to Biostatistics: Randomization, Hypothesis Testing and Sample Size. Design and Conduct of Observational Studies and Clinical Trials. Small Clinical Trials. Large Clinical Trials Clinical Research Institutes. Using Secondary Data in Statistical Analysis. An Introduction to Survival Analysis. Measures of Function and Health Related to Quality of Life. Economic Analysis and Clinical Research. Part III: Technology Transfer, Protocol Development and Funding Overview of Technology Development. Technology Transfer. Telemedicine Systems. Animal Models of Human Disease. Conducting and Evaluating Clinical Research on Complementary and Alternative Medicine. Preparing Scientific Images for Publication and Display. Writing a Clinical Protocol The Mechanics. Navigating the Peer Review Process for Grants.
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Review quote

"...this book clearly fulfills an important function for anyone involved in clinical research...this book will be accessible to a wide range of readers...this book is much needed and provides essentially all of the basic information required by investigators involved in clinical research, from both a practical perspective and a regulatory is an excellent starting point for those embarking on a clinical research project, as well as a valuable reference that experienced investigators will probably want to have readily available."-THE NEW ENGLAND JOURNAL OF MEDICINE (April 2003) "...a comprehensive treatment of the subject of clinical research...current and asset to a library or personal collection...Dr. John Gallin, Editor, is also an NIH clinical researcher...he and the majority of the 42 contributors are employed by the NIH...therefore, much of the content of this book is in the public domain, an added plus for instructors and students...subject selectors would be interested in all three of the books...however, the work by Dr. Gallin is the most comprehensive of the three...although corporations and universities conduct their own clinical research, they receive funding from or partner with this government agency...this book is recommended for university and hospital can also serve as a textbook for undergraduate and graduate health sciences and science majors...faculty members who engage in clinical research would also benefit from having this volume in their personal collection."-E STREAMS(June 2003) "This book is much needed and provides essentially all of the basic information required by investigators involved in clinical research. important resource for institional libraries and IRBs." THE NEW ENGLAND JOURNAL OF MEDICINE "...this volume provides an outstandingly comprehensive introduction to the field and can be recommended for virtually anyone who is interested in clinical research." CLINICAL INFECTIOUS DISEASES "Full of practical advice, top tips and the ever useful "Supplemental Reading" section, it even has a sample face sheet and a study design "tick list"." IMMUNOLOGY NEWS "...this book will benefit students, researchers, and clinical practitioners in allied health professions. It is recommended for larger academic and health science libraries." AMERICAN REFERENCE BOOKS ANNUAL "Suitable for use as a supplementary textbook or reference." BOOK NEWS
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Rating details

9 ratings
3.77 out of 5 stars
5 33% (3)
4 11% (1)
3 56% (5)
2 0% (0)
1 0% (0)
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