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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.
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.