The mission of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the United States Food and Drug Administration (FDA) is to identify, prioritize, sponsor, coordinate, and promote innovative activities — with a special interest in optimizing clinical trials — that will expedite the discovery and development of improved analgesic, anesthetic, and addiction treatments for the benefit of the public health.
ACTTION is a multi-year, multi-phase initiative that is closely aligned with the FDA's Critical Path Initiative. This public-private partnership has been designed to streamline the discovery and development process for new analgesic, anesthetic, and addiction medications and to more generally accelerate the development of treatments with improved efficacy and safety.
The key objectives of ACTTION involve initiating and supporting strategic collaborations among a broad spectrum of stakeholders — including, but not limited to, academia, the FDA and other government agencies, industry, professional organizations, patient advocacy groups, foundations, and philanthropic organizations — with the goals of sharing data and innovative thinking about the development of novel therapeutics. These strategic collaborations involve a wide range of research projects and other activities, for example, scientific workshops, consensus meetings, and in-depth analyses of clinical trial data to determine the effects of research methods on study assay sensitivity and efficiency.
ACTTION is intended to have benefits that are international in scope. To represent the bridges that ACTTION is establishing among its diverse stakeholders, this website is illustrated with watermarks of two bridges that share the distinction of connecting different continents. Directly below is the First Bosphorus Bridge in Istanbul, Turkey, which connects Europe and Asia; on the Contact Us webpage is the Leifur Eiriksson Bridge in Iceland's Reykjanes peninsula, which spans a rift valley between the North American and European continental plates.
February 5, 2014: Drs. Rice and Dworkin Authors of Article in the Lancet
Dr. Andrew Rice, Europain liaison to ACTTION, and Dr. Robert Dworkin, Director of ACTTION, have authored an article published in the Lancet describing the results of a placebo-controlled, double-blind randomized phase 2 clinical trial in patients with postherpetic neuralgia. The results of the trial showed that patients administered an angiotensin II type 2 receptor antagonist reported significantly less pain than patients who received placebo in the final week of a 28-day treatment period. The article was highlighted by the journal as an "Editor's Choice," and as noted in an accompanying Commentary by Drs. Nanna Finnerup and Cathrine Baastrup, the trial included several novel methodologic features recommended in recent IMMPACT publications on increasing assay sensitivity in analgesic trials.
Rice ASC, Dworkin RH, McCarthy TD, Anand P, Bountra C, McCloud PI, Hill J, Cutter G, Kitson G, Desem N, Raff M. EMA401, an orally administered highly selective angiotensin II type 2 receptor antagonist, as a novel treatment for postherpetic neuralgia: a randomised, double-blind, placebo-controlled phase 2 clinical trial. Lancet, early online publication, 5 February 2014. doi:10.1016/S0140-6736(13)62337-5
January 10, 2014: ACTTION-American Pain Society Pain Taxonomy Launched and Article to Appear in Journal of Pain
ACTTION and the American Pain Society (APS) have joined together to develop an evidence-based chronic pain classification system called the ACTTION-APS Pain Taxonomy (AAPT). A manuscript describing the outcome of an ACTTION-APS consensus meeting, at which a structure for this new taxonomy of chronic pain conditions was developed, has been accepted for publication in the Journal of Pain. AAPT will include the following dimensions: 1) Core Diagnostic Criteria, 2) Common Features, 3) Common Medical Comorbidities, 4) Neurobiological, Psychosocial, and Functional Consequences, and 5) Putative Neurobiological and Psychosocial Mechanisms, Risk Factors, and Protective Factors. Expert working groups are now applying this taxonomy to chronic pain conditions, thereby developing a set of diagnostic criteria that have been consistently and systematically implemented across common chronic pain conditions. It is anticipated that the availability of this evidence-based and mechanistic approach to pain classification will be of substantial benefit to chronic pain research and treatment.
Fillingim RB, Bruehl S, Dworkin RH, Dworkin SF, Loeser JD, Turk DC, Widerstrom-Noga E, Arnold L, Bennett R, Edwards RR, Freeman R, Gewandter J, Hertz S, Hochberg M, Krane E, Mantyh PW, Markman J, Neogi T, Ohrbach R, Paice J, Porreca F, Rappaport BA, Smith SM, Smith TJ, Sullivan MD, Verne GN, Wasan AD, Wesselmann U. The ACTTION-American Pain Society Pain Taxonomy (AAPT): an evidence-based and multi-dimensional approach to classifying chronic pain conditions. Journal of Pain, in press.
December 1, 2013: ACTTION Articles on Multiplicity and Authorship Disclosure to Appear in Pain
The following two ACTTION systematic reviews and recommendations have been accepted for publication in Pain. The articles describe systematic reviews of the reporting of primary analyses and multiplicity adjustment and of disclosure of authorship contributions in recent analgesic clinical trials, and include suggestions for the presentation of these important aspects of clinical trials in future publications.
Gewandter JS, Smith SM, McKeown A, Burke LB, Hertz SH, Hunsinger M, Katz NP, Lin AH, McDermott MP, Rappaport BA, Williams MR, Turk DC, Dworkin RH. Reporting of primary analyses and multiplicity adjustment in recent analgesic clinical trials: ACTTION systematic review and recommendations. Pain, in press.
Hunsinger M, Smith SM, McKeown A, Parkhurst M, Gross RA, Lin AH, McDermott MP, Rappaport BA, Turk DC, Dworkin RH. Disclosure of authorship contributions in analgesic clinical trials and related publications: ACTTION systematic review and recommendations. Pain, in press.
November 29, 2013: ACTTION Symposium at American Academy of Pain Medicine
A symposium on ACTTION – "Improving Pain Treatment Protocols: AAPM and the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the FDA" – will be held Friday, March 7 at the annual meeting of the American Academy of Pain Medicine (AAPM). The symposium will provide an overview of ACTTION, including recent efforts addressing treatment effectiveness studies using electronic health records, classifying opioid abuse-related events in clinical trials, developing standardized diagnostic criteria for chronic pain conditions, and clinical study methods to improve assay sensitivity. Ajay D. Wasan, MD, MSc (ACTTION Co-Chair representing AAPM), will moderate the symposium and present “An Overview of ACTTION,” and Shannon M. Smith, PhD (ACTTION Assistant Director), will describe "The Accomplishments of ACTTION."