Author: Shibadas Biswal
Publisher:
Published: 2017-12-19
Total Pages: 347
ISBN-13: 9781973576938
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This book is a must-read for students and professionals for a broad understanding of the entire process of clinical trial operation. In the second edition released in December 2017, we have added several new topics of interest taking the total count to 112. At the moment, a clinical trial is the most relevant method at our disposal to explore and establish safety/efficacy of a new medicine. It is the fundamental basis of clinical development programs of healthcare products. Clinical research has opened up several new career choices. Graduates in medicine, pharmacy, and other life sciences now have the option to work as investigators, scientists, project managers, data managers, monitors, study coordinators, regulatory affairs managers, and so on. Many of these positions have specialized and focused responsibilities in the industry setting. Considering the highly complex environment of clinical research, a broad overview is indispensable for effective collaboration.This book has been written for life science graduates aspiring to work in clinical research industry or clinical research professionals without considerable experience in trial operation. It would also be useful for professionals with focused responsibilities to broaden understanding of the entire gamut of trial operation. As fundamental approach is independent of nature of the investigational product (e.g. drug, device, vaccine or diagnostic agent), we are hopeful of its wider usefulness to the entire healthcare industry.The objective is to provide a broad outline of key activities, principles, roles, and responsibilities without getting into procedural details. Most organizations involved in clinical research have defined processes and procedures to carry out specific responsibilities relevant to their business. Hence, the discussion is purposefully limited to an overview to keep it concise yet informative. Discussion in each topic covers the background, operational overview, and usual challenges.Frequently used terminology has been introduced in the context of specific topics to induce familiarity. The book has been organized into several topics from the perspective of a project manager driving an entire trial. Organization of topics is according to the flow of trial operation from conception to the end. At the outset, the context of different trials according to phases of drug development has been introduced. Subsequent topics are on planning, setup, execution, and closeout in a sequential manner. Towards the end, the topics are on few general aspects of trial operation.This book has been written based on our practical experience, as well as regulatory guidance and other freely accessible literature. Good clinical practice (GCP) lays down the fundamental guiding principles for trial operation. Familiarity with any GCP guidance is highly recommended for the best outcome from this book.
