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Randomized Controlled Trials: Questions, Answers and Musings

Randomized Controlled Trials: Questions, Answers and Musings, 2nd edition, by Alejandro R. Jadad and Murray W. Enkin. Malden, MA: Blackwell Publishing; 2007. Paperback; 136 pages. ISBN 978-1-4051-3266-4. $35.95.

This well-written book is both concise and comprehensive. A revised edition of the 1998 Randomized Controlled Trials: A User’s Guide, the book introduces general understanding of the technicalities of clinical trial methodology, biases, ethics, implementation and challenges.

The principal author, Alex Jadad, widely recognized as an expert on the subject of clinical trial design, is the chief innovator and founder of the Center for Global eHealth Innovation, as well as a professor in the Department of Health Policy, Management and Evaluation at the University of Toronto. Jadad invited Murray Enkin, professor emeritus for the Departments of Obstetrics and Gynecology and Clinical Epidemiology and Biostatistics at McMaster University, to join him in a revised edition that combines wit with experience and ingenuity with cleverness. The authors, seasoned investigators and well recognized experts in “evidence based medicine” (use of evidence to improve clinical practice), excel in covering complex clinical trial methodology with quality and ethical issues and with examining the role of clinical research in evidence-based healthcare.

The book goes beyond mere explanations of randomized controlled trials (RCTs), their strengths and limitations, and how to use them while making healthcare decisions. It challenges conventional understanding of the complex interactions between clinical research and clinical practice, health professionals and patients, and pragmatism and the art of medicine. It also offers information about other types of valuable clinical studies and addresses issues applicable to major stakeholders in clinical research, including investigators, funding agencies, regulators, the pharmaceutical industry, healthcare professionals, and the seldom mentioned clinical trial participant.

The book echoes the thoughts of Sir Bradford Hill, the pioneer of modern RCTs, and his “disillusionment when he realized that RCTs can mislead as well as lead.” It debates the “gold standard/top of the pyramid of evidence” status of the RCT and challenges its application in modern healthcare, but also provides understanding of the theory of RCTs and their influence and importance in clinical, research, or policy decisions.

Compared to the first edition, the book includes enjoyable and insightful “musings” at the end of each chapter that describe the value of RCTs, as well as the challenges experienced by the authors themselves and a “wish list” of how to improve clinical research and patient care in general. The authors entice the reader to think and write new musings, to improve clinical trials, create research alternatives, search for new answers, and renew current thinking.

Each chapter answers questions with clear prose and judicious comments. Statistical concepts and medical and clinical trial examples are explained in detail. Each of the book’s 9 chapters also includes a comprehensive list of references including no less than 20 citations to landmark articles published in the peer-reviewed literature. New tables, figures and updated examples significantly increase the information provided. The Index provides valuable terms for easy access of specific information.

This is the sort of book that students will appreciate when they first learn about clinical trials, the busy health professional will use as a quick reference guide, the lay person will understand, and the experienced investigator will benefit from because it will challenge and defy current paradigms.

—Carmen Tamayo, MD Independent Consultant Integrative Medicine and Natural Health Products Bethesda, MD