Principles and Practice of Clinical Research

Name: Principles and Practice of Clinical Research
Price: 5.69 USD
Availability: InStock
ISBN: 9780123694409

ISBN-10: 012369440X

ISBN-13: 9780123694409

Edition: 2nd 2007

Authors: John I. Gallin, Frederick P. Ognibene

List price: $120.00

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Description:

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…

Book details

List price: $120.00
Edition: 2nd
Copyright year: 2007
Publisher: Elsevier Science & Technology
Publication date: 6/6/2007
Binding: Hardcover
Pages: 448
Size: 8.50" wide x 10.98" long x 0.40" tall
Weight: 2.750
Language: English



Preface


Acknowledgements


Historical Perspective and Introduction



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



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



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