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Medical Writings |3 April 2007

Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators

Roger J. Lewis, MD, PhD

Article, Author, and Disclosure Information
Author, Article, and Disclosure Information
  • From Harbor Medical Center, Torrance, California, and David Geffen School of Medicine and The Los Angeles Biomedical Research Institute, Los Angeles, California.

Structured abstracts of information on newly published books, computer programs, selected Web sites, and other material are provided in this portion of Medical Writings.
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Structured abstracts of information on newly published books, computer programs, selected Web sites, and other material are provided in this portion of Medical Writings.
Stone J. 427 pages. Cumberland, MD: Mountainside MD Pr; 2006. $69.95. ISBN 097491780X. Order at www.conductingclinicalresearch.com.
Field of medicine: Clinical research, especially for-profit pharmaceutical research.
Format: Softcover book.
Audience: Physicians, study nurses, study coordinators, and nonphysician scientists.
Purpose: To “provide an overview of how research is conducted for drug companies and how (one) might become involved.”
Content: This guide, written from the point of view of a site principal investigator contracting with a for-profit pharmaceutical sponsor, successfully covers a broad range of topics related to the implementation of clinical trials of pharmaceutical products. Practical considerations for identifying sponsors and potential studies, evaluating contracts, initiating studies, completing enrollment, and passing an audit are all covered, along with insightful introductions to regulatory issues, patient safety, ethical considerations, and societal and political issues affecting clinical research. Many substantive insights garnered from the author's own experience are included, and both the positive and negative aspects of conducting for-profit pharmaceutical research are fairly presented. Substantial background and resource information is included in 4 well-structured appendices.
Highlights: The text is well written and balances coverage of the relationships between for-profit entities and physician investigators with practical aspects of trial conduct. Information on contract negotiations and errors made by investigators is clearly presented. The author has an excellent sense of humor and appreciates the subtleties of the interactions between research participants and...
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Lewis RJ. Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators. Ann Intern Med. 2007;146:544. doi: 10.7326/0003-4819-146-7-200704030-00023

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Published: Ann Intern Med. 2007;146(7):544.

DOI: 10.7326/0003-4819-146-7-200704030-00023

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2007 American College of Physicians
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704

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