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Principles and practice of clinical research

Auteur : John I Gallin
Éditeur : San Diego, CA : Academic Press, 2002.
Édition/format :   Livre électronique : Document : AnglaisVoir toutes les éditions et tous les formats
Base de données :WorldCat
Résumé :
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  Lire la suite...
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Détails

Genre/forme : Llibres electrònics
Type d’ouvrage : Document, Ressource Internet
Format : Ressource Internet, Fichier informatique
Tous les auteurs / collaborateurs : John I Gallin
ISBN : 9780122740657 0122740653
Numéro OCLC : 804714461
Notes : Descripció feta a partir del volum imprès.
Description : 1 online resource (1 recurs electrònic (xv, 490 p.)) ill.
Contenu : 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. A historical perspective on clinical research / John I. Gallin --
Ethical principles in clinical research / Christine Grady --
Researching n bioethical question / Ezekiel J. Emanuel --
Integrity in research: individual and institutional responsibility / Alan N. Schechter --
Institutional review boards / Alison Wichman and Alan L. Sandler --
Data and safety monitoring boards / Lawrence M. Friedman --
Data and clinical management clinical trials / Jane Cassidy --
Unanticipated risk in clinical research / Stephen E. Straus --
The regulation of drugs and biological products by the Food and Drug Administration / Kathryn C. Zoon and Robert A. Yetter --
Legal issues / Patricia A. Kvochak --
NIH policy on the inclusion of women and minorities as subjects of clinical research / Eugene G. Hayunga and Vivian W. Pinn --
An introduction to biostatistics: randomizations, hypothesis testing, and sample size / Paul S. Albert and Craig B. Borkowf --
Design and conduct of observation studies and clinical trials / Teri A. Manolio --
Small clinical trials / Mitchell B. Max --
Large clinical trials: clinical research institutes / Robert M. Califf --
Using secondary data in statistical analysis / Bradley D. Freeman, Eric P. Gerstenberger, Steven Banks, and Charles Natanson --
An introduction to survival analysis / Joanna H. Shih --
Measures of function and health-related quality of life / Lynn H. Gerber --
Economic analysis and clinical research / Martin L. Brown, Keven B. Knopf, Stephen E. Marcus, and Joseph Lipscomb --
Overview of technology development / Bruce Goldstein --
Technology transfer / James Clifford Haight --
Telemedicine systems / Kenneth M. Kempner, Frank S. Govern, and Robert Martino --
Animal models of human disease / Domenico Accili --
Conducting and evaluating clinical research on complementary and alternative medicine / Wayne B. Jonas and Klaus Linde --
Preparing scientific images for publication and display / Christopher Vargas --
Writing a clinical protocol: the mechanics / Eddie Reed and Antoinette Jones-Wells --
Getting the funding you need to support your research: successfully navigating the NIH peer review process for grants / Olivia T. Preble Bartlett and Elliot Postow.
Responsabilité : John I. Gallin.

Résumé :

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. Key Features * Comprehensive review ranging from a historical perspective to the current ethical, legal and social issues and an introduction to biostatistics and epidemiology * Practical guide to writing a protocol, getting funding for clinical research, preparing images for publication and display * Cohesive and clear presentation by authors carefully selected to teach a very popular course at NIH * Excellent companion text for courses on clinical research.

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