Clinical trials: A Beginner's Guide

P Usha Rani 
 Departments of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad - 500 082, India

Correspondence Address:
P Usha Rani
Departments of Clinical Pharmacology and Therapeutics, Nizam«SQ»s Institute of Medical Sciences, Panjagutta, Hyderabad - 500 082
India

Full Text

[AUTHOR:1]

Alice Kuruvilla, A. D. Paul Alice Kuruvilla

Publisher: Paras Medical Publishers,

5-1-475, First Floor, Putlibowli, Hyderabad - 500095, India

Edition: 1 st Edition, 2013

pp: 260

ISBN: 978-81-8191-393-7

Clinical research is now being conducted not only at big institutes but also by investigators in their respective centers. Hence, it is necessary that researchers understand the basic principles of study design, data analysis, and conduct a trial as per the Good Clinical Research Guidelines. The new book "Clinical Trials: A Beginner's Guide" is simple, comprehensive, and covers all the essential topics for beginners. A chapter is devoted to each of the essential aspects of clinical trials including ethical, regulatory, statistical, safety, and pharmacovigilance issues. The key points if given in a separate box will be really beneficial for beginners. This book is ideal for those wishing to learn about clinical trials for the first time, or as a quick reference guide for busy clinicians. Chapter on "drug discovery and development" covered all aspects from preclinical phase through all phases of clinical trials up to recent advances in drug discovery. Inclusion of "a note on special groups for clinical trials as well as special consideration for vaccine and medical devices trials" in the chapter on "clinical trials - an overview" is in accordance with the present requirement. Chapters on "Regulatory requirement, Good Clinical Practice (GCP), and Ethics in clinical trials" are well written, however, a note on the recent guidelines may be incorporated for completeness of information. Chapters on "Monitoring of clinical trials and Audits and inspections" are described in a lucid manner and add flavor to the book's content. There is an interesting chapter on data management and statistical issues, which are often missed by beginners. Last but not the least, Pharmacovigilance, which is now taking the forefront, is very adequately described. The book addresses most of the issues on clinical research and provides a comprehensive overview for students and researchers.