John Posner

A Guide to Clinical Drug Research John Posner 2nd ed. 2000 edition

Marc Notes: Includes bibliographical references and index. Table of Contents: 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 protocol. 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. Publisher Marketing: Following the success of the first edition, published in 1995, this fully rewritten work has been adapted to the most up-to-date 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. It is not restricted to drug investigation, and is relevant to all those involved in clinical research in a variety of settings. Review Citations:

Scitech Book News 09/01/2000 pg. 96 (EAN 9780792361718, Hardcover)

Contributor Bio:  Cohen, Adam Cohen is a senior writer for the Nation section of Time, where he covers law and politics. He has also written for Chicago Magazine, the Chicago Tribune, and the Harvard Law Review.