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, addiction, and peripheral neuropathy 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, addiction, and peripheral neuropathy 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.
June 11, 2018: Updates on Novel Clinical Outcome Assessments
- QUALITE-Pain (QUALIfied for Therapeutic Evaluations of Pain), led by Shannon Smith, PhD, ACTTION Senior Assistant Director: Individuals with diverse acute and chronic pain conditions have been interviewed about their experiences with pain, understanding of several existing pain measures, and opinions about how their pain should be rated. Qualitative analyses of these interviews are ongoing, and the results will inform the development of the conceptual framework for QUALITE-Pain.
- PAACT (Physical Activity Accelerometry Assessment for Analgesic Clinical Trials), led by Kushang Patel, PhD, ACTTION Assistant Director: FDA has entered PAACT into the Clinical Outcomes Assessments Drug Development Tools qualification program, and a draft protocol for qualitative studies is being prepared and will be submitted to the FDA for comments.
April 26-29, 2018: ACTTION at American Academy of Pain Medicine (AAPM), Vancouver
- A symposium focusing on the ACTTION-American Pain Society-AAPM Pain Taxonomy (AAAPT) for acute pain was chaired by Patrick Tighe, MD, and included presentations by him, Stephen Bruehl, PhD, and Carleton Dampier, MD, who discussed progress in the development of new taxonomies of pain, research methods for validating novel diagnostic criteria, and recent diagnostic criteria for acute and chronic pain associated with sickle cell disease.
- Patrick Tighe, MD, received an AAPM Presidential Commendation in recognition of his contributions to the development of the AAAPT acute pain taxonomy and multidimensional framework and to the AAPM acute pain special interest group and journal, Pain Medicine.
- Robert H. Dworkin, PhD, ACTTION Director, received the AAPM Founders Award, which is given "for outstanding contributions to the science or practice of pain medicine. This award is given for continued contributions for the basic or clinical science of pain medicine or for demonstration of clinical excellence or innovation in the practice of pain medicine."
April 26, 2018: ACTTION to Present at World Congress of Pain, Boston
Shannon Smith, PhD, ACTTION Senior Assistant Director, and colleagues have had a presentation accepted for the World Congress on Pain, to be held in Boston from September 12-16, 2018. The presentation describes the results of a systematic review of methodologic and statistical characteristics of randomized clinical trials designed to test non-inferiority or equivalence of pain treatments. The full reference for the presentation follows: Smith SM, Gewandter JS, Chaudari J, McDermott MP, Gilron I, Kitt R, Koch J, Majeed Z, Turk DC, Dworkin RH. Trials designed to test non-inferiority or equivalence of two pain treatments: an ACTTION systematic review.
April 14-15, 2018: ACTTION at PANDA, New York City
The Sixth PANDA symposium on "Anesthesia and Neurodevelopment in Children," co-sponsored by SmartTots and Columbia University, was convened to provide an update on research investigating potential neurotoxicity of anesthetic agents and to discuss important emerging research and clinical issues. Robert Dworkin, PhD, ACTTION Director, delivered an invited presentation on "Experiences of ACTTION: engaging the research community."