Principles and Practice of Clinical Research
Editat de John I. Gallin, Frederick P Ognibeneen Limba Engleză Hardback – 9 iul 2012
- Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research
- Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research
- Delves into data management and addresses how to collect data and use it for discovery
- Contains valuable, up-to-date information on how to obtain funding from the federal government
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Specificații
ISBN-13: 9780123821676
ISBN-10: 0123821673
Pagini: 796
Ilustrații: 1
Dimensiuni: 216 x 276 x 43 mm
Greutate: 2.36 kg
Ediția:3rd revised edition.
Editura: ELSEVIER SCIENCE
ISBN-10: 0123821673
Pagini: 796
Ilustrații: 1
Dimensiuni: 216 x 276 x 43 mm
Greutate: 2.36 kg
Ediția:3rd revised edition.
Editura: ELSEVIER SCIENCE
Public țintă
All individuals engaged in clinical research both student and researcher as well as physicians, dental investigators, PhD basic scientists, and members of allied health professionsCuprins
•A Historical Perspective on Clinical Research
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 Management in Clinical Trials
•Unanticipated Risks in Clinical Research
•The Regulation of Drugs and Biological Products by the Food and Drug Administration
•Legal Issues
•Rules to Prevent Conflict of Interest for Clinical Investigators Conducting Human Subjects Research
•National Institutes of Health Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research
•Clinical Research: A Patient Perspective
•The Clinical Researcher and the Media
BIOSTATISTICS AND EPIDEMIOLOGY
•An Introduction to Biostatistics: Randomization, Hypothesis Testing, and Sample Size Estimation
•Design and Conduct of Observational Studies and Clinical Trials
•Small Clinical Trials
•Large Clinical Trials and Registries - Clinical Research Institutes
•Using Secondary Data in Statistical Analysis
•An Introduction to Survival Analysis
•Measures of Function and Health-Related Quality of Life
TECHNOLOGY TRANSFER, PROTOCOL DEVELOPMENT, FUNDING AND OTHER ISSUES
•Overview of Technology Development
•Technology Transfer
•Writing a Protocol
•Evaluating a Protocol Budget
•Data Management in Clinical Research: General Principles and a Guide to Sources
•Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process
•Clinical Research from the Industry Perspective
•Human Genome Project, Genomics, and Clinical Research
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 Management in Clinical Trials
•Unanticipated Risks in Clinical Research
•The Regulation of Drugs and Biological Products by the Food and Drug Administration
•Legal Issues
•Rules to Prevent Conflict of Interest for Clinical Investigators Conducting Human Subjects Research
•National Institutes of Health Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research
•Clinical Research: A Patient Perspective
•The Clinical Researcher and the Media
BIOSTATISTICS AND EPIDEMIOLOGY
•An Introduction to Biostatistics: Randomization, Hypothesis Testing, and Sample Size Estimation
•Design and Conduct of Observational Studies and Clinical Trials
•Small Clinical Trials
•Large Clinical Trials and Registries - Clinical Research Institutes
•Using Secondary Data in Statistical Analysis
•An Introduction to Survival Analysis
•Measures of Function and Health-Related Quality of Life
TECHNOLOGY TRANSFER, PROTOCOL DEVELOPMENT, FUNDING AND OTHER ISSUES
•Overview of Technology Development
•Technology Transfer
•Writing a Protocol
•Evaluating a Protocol Budget
•Data Management in Clinical Research: General Principles and a Guide to Sources
•Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process
•Clinical Research from the Industry Perspective
•Human Genome Project, Genomics, and Clinical Research
Recenzii
PRAISE FOR THE FIRST EDITION: "...much needed and provides essentially all of the basic information required by investigators involved in clinical research. ...an important resource for institutional libraries..." --THE NEW ENGLAND JOURNAL OF MEDICINE
"...it really is a step-by-step DIY book for the uninitiated proposal writer. 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
"Principles and Practice of Clinical Research, 3rd Edition is 80% larger than the second edition. Most of the authors are with the National Institutes of Health, but the material is largely applicable to both government- and industry-funded research…This book has been selected for The First Clinical Research Bookshelf, essential reading for clinical research professionals." --Journal of Clinical Research Best Practices, May 2013
"...it really is a step-by-step DIY book for the uninitiated proposal writer. 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
"Principles and Practice of Clinical Research, 3rd Edition is 80% larger than the second edition. Most of the authors are with the National Institutes of Health, but the material is largely applicable to both government- and industry-funded research…This book has been selected for The First Clinical Research Bookshelf, essential reading for clinical research professionals." --Journal of Clinical Research Best Practices, May 2013