Author: Frank Breve, Errol M. Gould, Marc Hoffman, Ernest A. Kopecky, Srinivas Nalamachu, Joseph V. Pergolizzi, Robert B. Raffa, Robert Taylor, Jr.
The significance of investigational drugs can be identified by performing a variety of clinical studies. These studies can range from bench top to bedside and include various populations like pediatrics and geriatrics. This course will address the elements related to the clinical study of analgesics. Discussed with be new analgesic drugs; their mechanism of action; how to design a study around these characteristics; why trial design for these types of analgesics (and others) do not always mimic clinical practice; and pitfalls of analgesic trials. Issues surrounding some of the new regulatory requirements of analgesics, especially controlled substances, and the impact of these requirements on trial design will be presented. In addition, dissemination of data from analgesic clinical studies into the public domain will be covered. At the conclusion of the program, participants will have a comprehensive understanding of analgesic trial design and reporting. (Recorded at PAINWeek 2016)