Principles of Clinical Research

by Giovanna di Ignazio (Editor), Ignazio Di Giovanna

In an arena that has seen rapid change over the past decade, this important new book provides a comprehensive, practical and up-to-date guide to the planning, organization and management of clinical trials. The contributors are drawn from the pharmaceutical industry, from contract research organizations and from academia. The style is very accessible and this book will be used as a text by those new to clinical research and as an invaluable reference tool for those with more experience of this multidisciplinary, multinational, multibillion-dollar industry. All aspects and all stages of clinical research are covered, including clinical trial design, protocol writing, case record form design, pharmacokinetics, selection of investigators and volunteers, safety issues, adverse reactions and monitoring, outcomes research, statistics, data management, archiving, audits and communication. Chapters on new topics that increasingly affect everyone involved in clinical research, such as outsourcing, regulations for biotechnology products, legal and ethical issues (including the October 2000 amendment to the World Medical Association Declaration of Helsinki), fraud and malpractice are also included.

576 pages, Hardcover

First published March 30, 2001