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A Guide to Clinical Drug Research provides practical advice, 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 pharmaceutical company, plus agents of the sponsoring companies themselves.
The book contains black-and-white illustrations.
|List of contributors|
|1||Clinical research: From idea to publication||1|
|2||Facilities and equipment||11|
|3||What does the investigator need to know about the drug?||17|
|4||The first administration of a new active substance to humans||39|
|5||Planning and coordinating the study||57|
|6||The study protocol||65|
|8||Data management and statistical analysis||85|
|10||Aspects of study conduct||111|
|11||Good clinical practice||127|
|12||Communicating clinical research||139|
|13||Clinical research in a developing country||157|
|14||Computers in clinical research||171|