A practical guide to human research and clinical trials

AJ Singh 
 Professor and Head, Department of Pharmacology, AMC MET Medical College, Maninagar, Ahmedabad, India

Correspondence Address:
A J Singh
Professor and Head, Department of Pharmacology, AMC MET Medical College, Maninagar, Ahmedabad
India

Full Text

[AUTHOR:1]

M.U.R. Naidu and P. Usha Rani (Eds.)

Publishers: PharmaMed Press, Hyderabad, 1 st edn., 2011, ISBN 978-81-7800-260-6, pp 327

This small, yet comprehensive publication is a commendable effort on the part of various authors to summarize, and yet give practical tips on the conduct of Clinical Research. The topics covered seamlessly lead the reader through the complex maze of the clinical trial design and conduct.

This book is a refreshing addition to others available in this field. It actually can be considered as a ''stand alone" text in that it aims to be comprehensive, yet brief. Several chapters are devoted to the topics that have not been addressed fully by earlier publications for e.g., microdosing or phase '0' studies, randomization, phamacovigilance, DSMB, etc. A very comprehensive coverage of a number of critical areas like medical devices, investigational medical products, informed consent, monitoring, QA, standard operating procedures and archiving has been provided. In particular, the chapters on medical devices and SOP writing contain some valuable information that is not available elsewhere. Good Clinical Practice (GCP) and the related topics have been addressed briefly but adequately. A well-needed glossary and references for further reading are welcome features of this book.

A few improvements can be suggested for the future versions. The chapter on planning of clinical trials should also include the details of management tools like critical path method, decision analysis, Gantt charts that are routinely used. Similarly, the chapter on statistics may also describe the analysis of clinical trials, sample size calculation, data entry and meta-analysis. An increasingly greater importance is getting attached to the Ethics Committees and this need to be described in greater details. Drug regulations, schedule Y and the principles of evidence-based medicine are some other areas that deserve to be dealt with at length.

Overall, this is a much-needed text for all postgraduate students in pharmacology intending to appear for their M.D. examination. It should be equally useful to the new clinical research investigators, Clinical Trial Coordinators, CRAs, monitors and other stakeholders in clinical research. It will also be an important tool for the medical advisors and clinical research personnel working with the pharmaceutical industry.