Edited by Raymond S. Sinatra
Edited by Oscar A. de Leon-Cassasola
Edited by Eugene R. Viscusi
Edited by Brian Ginsberg
Foreword by Henry McQuay
Publisher: Cambridge University Press
Print Publication Year: 2009
Online Publication Date:October 2009
Chapter DOI: http://dx.doi.org/10.1017/CBO9780511576706.044
The current revision of this textbook is a testament to the ongoing evolution of new techniques, agents, and devices specifically for the management of acute pain. Medical practice generally has concurrently evolved to a state where clinical practices are increasingly guided by thoughtful review of the best available evidence. Consequently, the ability to judge the evidence from clinical trials, no longer the exclusive province of editors and academics, is now of primary importance to all clinicians.
Clinical analgesic trials serve two masters. Regulatory agencies require evidence of safety and efficacy. Practitioners require clinically relevant evidence to establish or modify best practices in caring for their patients. The resultant jargon, acronyms, and procedural peculiarities that accompany the merger of these two purposes can present a challenge to clinicians not familiar with research methods as they attempt to judge the quality and practical applicability of this evidence. Similarly, the terminology used to provide the rationale behind the clinical trial process can seem like a language unto itself. The purpose of this chapter is to briefly translate some of the more common terms, explain the rationale behind their use and misuse, and point out frequently encountered pitfalls in trial design. Our intention in this brief introduction to the interpretation of clinical trials is to assist the research naïve clinician to better evaluate the quality of published analgesic studies.