A Guide to Clinical Drug Research

Front Cover
A. Cohen, J. Posner
Springer Science & Business Media, Apr 30, 2000 - Medical - 206 pages
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 protocol, 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.
 

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Contents

From idea to publication
1
Facilities and Equipment
13
know about the drug? the Clinical Investigators Brochure
19
substance to humans
47
Planning and coordinating the study
65
The study protocol
73
Study Design
87
analysis
99
Ethical considerations
113
Aspects of study conduct
127
Good clinical practice
145
Communicating Clinical Research
159
The Clinical Study Report
179
country
187
Index
203
Copyright

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About the author (2000)

Adam Cohen is a senior writer for the Nation section of "Time", where he covers law & politics. He has also written for "Chicago Magazine", the "Chicago Tribune", & the "Harvard Law Review". He lives in New York.

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