Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks

The November issue of Pain (2013, volume 154, issue 11) contains two commentaries about ACTTION articles published in the same issue. In "The IMMPACT factor or IMMPACT strikes again!," Stephen Butler, MD, discusses IMMPACT recommendations for abuse liability measures to be used in analgesic clinical trials in patients with pain. The commentary begins "'Not another article from IMMPACT!' may be your first reaction when glancing at the Table of Contents in this month’s issue of Pain. The IMMPACT group continues to supply a tremendous amount of valuable information on the proper design of drug studies. This has been constructive in the dialogue between the pharmaceutical industry and licensing bodies involved in controlling market access for new compounds for pain. IMMPACT recommendations are also important for any group performing drug studies because they represent the established norms and opinions of experts across industry, academe, and the FDA. They are also useful guides to help critical reading of such studies, especially when study design problems can affect intelligent interpretation of results."In a second commentary, Mark Sullivan, MD, discusses ACTTION recommendations for the classification and definition of misuse, abuse, and related events in clinical trials. The commentary notes that after reviewing existing definitions of misuse, abuse, and related events and finding that terms were often defined inconsistently or idiosyncratically, ACTTION developed "definitions for use in analgesic clinical trials, post-marketing adverse event monitoring, and, hopefully, clinical care. This is an important attempt at standardizing terminology around opioid misuse and abuse that should greatly aid communication and comparison across studies."