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A Quick Guide to Clinical Trials; “For people who may not know it all”

Published by: BioPlan Associates, Inc.

Published: Apr. 1, 2008 - 208 Pages


Table of Contents


Introduction: What’s in it for me: why should I read this book?

Drs. Madhu Davies and Faiz Kermani

Chapter 1: Why do we do clinical trials?

Dr. Graham Wiley, CEO, Medical Research Network

Chapter 2: The FDA and clinical trials: a short history

Dr. Suzanne Junod, Food and Drug Administration

Chapter 3: The business of successful clinical drug development

Drs. James McClurg and Todd Johnson

Chapter 4: The clinical trial process: project management

Mrs Jan Robinson, PharmaKodex Ltd

Chapter 5: The clinical trial process: primer on ethics in clinical research

Dr. Felix Khin-Maung-Gyi, CEO Chesapeake Research Review Inc

Chapter 6: The clinical trial process: regulatory affairs

Mrs. Sue Green, Shore Ltd

Chapter 7: The clinical trial process: monitoring

Drs. Ignazio di Giovanni/Gareth Hayes Campbell Charles Associates Ltd and PhlexGlobal Ltd

Chapter 8: The clinical trial process: statistics

Dr. Cathy O’Brien Fincham Statistics

Chapter 9: The clinical trial process: data management

Mrs. Lisa Nash, GlaxoSmithKline

Chapter 10: The clinical trial process: technology in clinical trials

Drs. Bill Byrom and David Stein, Clinphone Ltd

Chapter 11: Clinical trials and medical writing

Mrs. Fiona Swain, Swain Associates

Chapter 12: Clinical trials and the clinical research physician

Dr. Madhu Davies

Chapter 13: Clinical trials and the patient

Mrs. Liz Langley, LHA Ltd

Chapter 14: The future of clinical trials

Dr. Faiz Kermani

Glossary

Abstract

Quick Guide to Clinical Trials provides a fresh overview of the clinical trials process, history, and background. Written by major industry experts, including the US FDA, and some of the largest international clinical trials managers, this book provides an easy-to-read, conversational view point on the importance, the shortcomings, and intricacies of the clinical trials process. It is intended for those new to clinical trials, as well as knowledgable readers, industry participants, and even patients considering participating in clinical trials. A broad audience can appreciate the content because it includes little-known facts and information, as well as solid, but easily managed, technical material.

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