Principles and Practice of Clinical Research, (Principles & Practice of Clinical Research)

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9780123694409: Principles and Practice of Clinical Research, (Principles & Practice of Clinical Research)

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.This book 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. It addresses the vast opportunities for translation of basic science observations to the bedside through clinical research. It delves into data management and addresses how to collect data and use it for discovery. It contains valuable, up-to-date information on how to obtain funding from the federal government.

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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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