Overview

The third edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.

Full Product Details

Author:   John I. Gallin ,  Frederick P. Ognibene
Publisher:   Elsevier Science Publishing Co Inc
Imprint:   Academic Press Inc
Edition:   3rd edition
Dimensions:   Width: 21.60cm , Height: 4.30cm , Length: 27.60cm
Weight:   2.360kg
ISBN:  

9780123821676

ISBN 10:   0123821673
Pages:   796
Publication Date:   31 May 2012
Audience:   Professional and scholarly ,  Professional & Vocational
Replaced By:   9780128499054
Format:   Hardback
Publisher's Status:   Active
Availability:   Manufactured on demand  
We will order this item for you from a manufactured on demand supplier.

Table of Contents

*A Historical Perspective on Clinical ResearchETHICAL, 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 MediaBIOSTATISTICS 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 LifeTECHNOLOGY 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

Reviews

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

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