The Design of Analgesic Clinical Trials

In this text specialists in the area of analgesic trial design present a guide to the clinical evaluation of agents and methods for acute and chronic pain control. The material in the book deals with topics such as chronic drug studies, tailoring designs to patients with specific diseases, probing neural mechanisms of pain, integrating recent advances in pharmacokinetics and statistics, and studying the effectiveness of efforts to improve clinicians' analgesic practice. For investigators studying the properties and clinical potential of analgesic compounds, the book reviews the regulatory requirements, describes the most efficient ways to screen for efficacy and toxicity, and explains how to plan a series of controlled trials, choosing from many standard clinical "pain models". For clinicians seeking improved strategies for pain relief, the book presents analgesic trials for specific types of pain such as postoperative pain, neuropathic pain syndromes, cancer pain, low back pain, osteoarthritis, sickle cell disease, sports injuries, orofacial pain, headache and dysmenorrhea.
Also included are discussions of new methodologies in analgesic studies - such as multiple dose studies; comparing spinal, transdermal, and other novel routes to standard oral or systemic administration; patient-controlled analgesia paradigms; evaluation of analgesic prescribing practices; and advances in pharmacokinetics and biostatistics. Following many of the chapters are commentaries by experts in analgesic research that highlight unresolved issues and ongoing controversies.