In an arena which has seen rapid change over the past decade, Principles of Clinical Research provides a straightforward and up-to-date guide to the planning, organization and management of clinical trials.



With a very practical emphasis, all aspects of the scientific and ethical conduct of clinical research are covered, including trial design, protocol writing, case record form design, pharmacokinetics, selection of volunteers and investigators, safety issues, adverse events and monitoring, outcomes research, statistics, data management, archiving, audits, and communications. Focusing also on controversial topics which are of increasing concern in clinical studies, separate chapters are devoted to outsourcing, regulations for biotechnology products, legal and ethical issues, and fraud and malpractice.



Bibliographics and a comprehensive subject index further enhance the book’s accessibility as a reference source.



Wherever clinical research is conducted, whether in the pharmaceutical industry, contract research organization or academia, this authoritative volume will be an invaluable aid to all clinical research personnel, and for new and recent recruits to the industry it will be essential reading.