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A Guide to Clinical Drug Research / Edition 2

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Overview

Following the success of the first edition, published in 1995, this fully rewritten A Guide to Clinical Drug Research - Second Edition has been adapted to the most recent guidelines and developments in the field. It continues to provide a wealth of practical advice, ranging from the conception of an idea, planning a study and writing a prool, through to the conduct of a study, data collection and analysis, and publication. It tells investigators what information they should expect sponsoring companies to provide, particularly when there is only limited information available about a new drug. It also explains what the company can expect of investigators, including the requirements of 'good clinical practice'. Unlike other currently available texts on clinical trials and pharmaceutical medicine, A Guide to Clinical Drug Research concentrates on the needs of the practising clinician and research team. It is not restricted to drug investigation, and is relevant to all those involved in clinical research in a variety of settings.
Audience: Required reading for clinical researchers and others involved as investigators in a drug project, often sponsored by a pharmacuetical company, plus agents of the sponsoring companies themselves.

The book contains black-and-white illustrations.

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Editorial Reviews

Christopher J. Kratochvil
A systematic overview of clinical research from the investigator's perspective is provided. The editors provide a timely update of the first edition, which was published in 1995. The editors developed this book to provide pertinent information about all aspects of drug research in man, ""... from the initial research idea to the ultimate publication and every step in between."" The book is designed to be a primer for those setting out to become clinical investigators, as well as a tool to ""fill the gaps"" for those with more experience in the field. The editors have succeeded in these aims by assembling a diverse panel of expert contributors. Although the focus is upon pharmaceutical research, the book is quite appropriate for anyone designing or conducting clinical research. The title is an apt description of this book as a guide, as readers are led systematically through the preparation, completion, and reporting of a clinical trial. Issues regarding study design, facilities, equipment, planning, coordinating, data management, ethical considerations, and good clinical practices are all reviewed. Particularly useful are the descriptions of what an informed investigator should know about a drug prior to initiating or agreeing to participate in a clinical trial. This book is not a complete reference for those designing and conducting clinical research, but it is an excellent overview and readers are directed to pertinent references. As an investigator who conducts investigator-initiated as well as collaborative multi-site trials, I found this book to have great utility. There are few resources in which these important issues are addressed. I would recommend this book to thoseconducting multi-site trials as a guide for critically evaluating proposed projects and to those designing and implementing their own studies as an excellent guide about what to do and what not to forget.
Booknews
Provides practical advice on the entire process of conducting clinical drug research, from conception of an idea to publication, concentrating on the needs of practicing clinicians and research teams. Tells investigators what information they should expect sponsoring companies to provide, and explains what the company can expect of investigators, including requirements of good clinical practice. This second edition is rewritten to reflect recent guidelines and developments in the field. Cohen is professor of clinical pharmacology at the University of Leiden, The Netherlands, and director of the Center for Human Drug Research at Leiden University Hospital; Posner is an independent consultant in pharmaceutical medicine. Annotation c. Book News, Inc., Portland, OR (booknews.com)
Doody's Review Service
Reviewer: Christopher J. Kratochvil, MD (University of Nebraska Medical Center)
Description: A systematic overview of clinical research from the investigator's perspective is provided. The editors provide a timely update of the first edition, which was published in 1995.
Purpose: The editors developed this book to provide pertinent information about all aspects of drug research in man, "... from the initial research idea to the ultimate publication and every step in between."
Audience: The book is designed to be a primer for those setting out to become clinical investigators, as well as a tool to "fill the gaps" for those with more experience in the field. The editors have succeeded in these aims by assembling a diverse panel of expert contributors. Although the focus is upon pharmaceutical research, the book is quite appropriate for anyone designing or conducting clinical research.
Features: The title is an apt description of this book as a guide, as readers are led systematically through the preparation, completion, and reporting of a clinical trial. Issues regarding study design, facilities, equipment, planning, coordinating, data management, ethical considerations, and good clinical practices are all reviewed. Particularly useful are the descriptions of what an informed investigator should know about a drug prior to initiating or agreeing to participate in a clinical trial. This book is not a complete reference for those designing and conducting clinical research, but it is an excellent overview and readers are directed to pertinent references.
Assessment: As an investigator who conducts investigator-initiated as well as collaborative multi-site trials, I found this book to have great utility. There are few resources in which these important issues are addressed. I would recommend this book to those conducting multi-site trials as a guide for critically evaluating proposed projects and to those designing and implementing their own studies as an excellent guide about what to do and what not to forget.

5 Stars! from Doody
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Product Details

  • ISBN-13: 9780792361725
  • Publisher: Springer Netherlands
  • Publication date: 4/30/2000
  • Edition description: 2nd ed. 2000. Softcover reprint of the original 2nd ed. 2000
  • Edition number: 2
  • Pages: 206
  • Product dimensions: 9.21 (w) x 6.14 (h) x 0.48 (d)

Table of Contents

Foreword to the first edition. Editors' notes to the second edition. Glossary of commonly used terms. List of contributors. Clinical research: From idea to publication. Facilities and Equipment. What does the investigator need to know about the drug? the Clinical Investigator's Brochure. The first administration of a new active substance to humans. Planning and coordinating the study. The study prool. Study Design. Data management and statistical analyses. Ethical considerations. Aspects of study conduct. Good clinical practice. Communicating Clinical Research. The Clinical Study Report. Clinical research in a developing country. Index.

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