Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations

Stephen A Cooper; Paul J Desjardins; Dennis C Turk; Robert H Dworkin; Nathaniel P Katz; Henrik Kehlet; Jane C Ballantyne; Laurie B Burke; Eugene Carragee; Penney Cowan; Scott Croll; Raymond A Dionne; John T Farrar; Ian Gilron; Debra B Gordon; Smriti Iyengar; Gary W Jay; Eija A Kalso; Robert D Kerns; Michael P McDermott; Srinivasa N Raja; Bob A Rappaport; Christine Rauschkolb; Mike A Royal; Märta Segerdahl; Joseph W Stauffer; Knox H Todd; Geertrui F Vanhove; Mark S Wallace; Christine West; Richard E White; Christopher Wu

doi:10.1097/j.pain.0000000000000375

Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations

Pain. 2016 Feb;157(2):288-301. doi: 10.1097/j.pain.0000000000000375.

Affiliation

¹ Stephen A. Cooper, LLC, Palm Beach Gardens, FL, USA Desjardins Associates, LLC and Department of Oral and Maxillofacial Surgery, Tufts University, Boston, MA, USA Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA Departments of Anesthesiology, Neurology, and Biostatistics and Computational Biology, University of Rochester, Rochester, NY, USA Analgesic Solutions, Needham, MA, USA Section for Surgical Pathophysiology, Rigshospitalet, Copenhagen, Denmark Department of Health Services Research, University of Maryland, Baltimore, MD, LORA Group, LLC, Royal Oak, MD, USA Department of Orthopedic Surgery, Stanford University, Palo Alto, CA, USA American Chronic Pain Association, Rocklin, CA, USA Walter Reed Army Medical Center, Washington, DC, USA Departments of Pharmacology, Toxicology and Foundational Sciences, East Carolina University, Greenville, NC, USA Department of Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA Department of Anesthesiology, Queens University, Kingston, Ontario, Canada Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA Eli Lilly & Co, Indianapolis, IN, USA Advise Clinical, Raleigh, NC, USA Department of Anaesthesia, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland United States Department of Veterans Affairs, New Haven, CT, USA Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, USA Analgesic Concepts, LLC, Arlington, VA, USA Johnson & Johnson Pharmaceutical Research and Development, Titusville, NY, USA Sorrento Therapeutics, San Diego, CA, USA Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden JohnsHopkinsUniversity, Baltimore, MD, USA, and Cara Therapeutics, Shelton, CN, USA Department of Emergency Medicine, MD Anderson Cancer Center, University of Texas, Houston, TX, USA NeurogesX, San Carlos, CA, USA Department of Anesthesiology, University of California San Diego, San Diego, CA, USA Pfizer, Inc, Groton, CT, USA Endo Pharmaceuticals, Chadds Ford, PA, USA.

PMID: 26683233
DOI: 10.1097/j.pain.0000000000000375

Abstract

This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable to many other acute pain studies conducted in different settings.

Publication types

Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Review

MeSH terms

Acute Pain / diet therapy*
Analgesics / therapeutic use*
Clinical Trials as Topic / methods*
Clinical Trials as Topic / standards
Humans
Pain Measurement / standards*
Research Design* / standards

Substances

Analgesics

Grants and funding

U01 FD005936/FD/FDA HHS/United States