Principles and Practice of Clinical Research 2nd Edition by John Gallin ISBN 9780123694409 012369440X

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Product details: 

ISBN 10: 012369440X

ISBN 13: 9780123694409

Author:  John I. Gallin 

The second 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. *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

Table of contents: 

1 A Historical Perspective on Clinical Research
2 ETHICAL, REGULATORY, AND LEGAL ISSUES
3 Ethical Principles in Clinical Research
4 Researching a Bioethical Question
5 Integrity in Research Individual and Institutional Responsibility
6 Institutional Review Boards
7 Data and Safety Monitoring Boards
8 Data Management in Clinical Trials
9 Unanticipated Risks in Clinical Research
10 The Regulation of Drugs and Biological Products by the Food and Drug Administration
11 Legal Issues
12 Rules to Prevent Conflict of Interest for Clinical Investigators Conducting Human Subjects Research
13 National Institutes of Health Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research
14 Clinical Research A Patient Perspective
15 The Clinical Researcher and the Media
16 BIOSTATISTICS AND EPIDEMIOLOGY
17 An Introduction to Biostatistics Randomization, Hypothesis Testing, and Sample Size Estimation
18 Design and Conduct of Observational Studies and Clinical Trials
19 Small Clinical Trials
20 Large Clinical Trials and Registries – Clinical Research Institutes
21 Using Secondary Data in Statistical Analysis
22 An Introduction to Survival Analysis
23 Measures of Function and Health-Related Quality of Life
24 TECHNOLOGY TRANSFER, PROTOCOL DEVELOPMENT, FUNDING AND OTHER ISSUES
25 Overview of Technology Development
26 Technology Transfer
27 Writing a Protocol
28 Evaluating a Protocol Budget
29 Data Management in Clinical Research General Principles and a Guide to Sources
30 Getting the Funding You Need to Support Your Research Navigating the National Institutes of Health Peer Review Process
31 Clinical Research from the Industry Perspective
32 Human Genome Project, Genomics, and Clinical Research

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