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.
September 18, 2017: ACTTION Reaches Milestone of 75 Publications
Since its launch in late 2010, ACTTION has published a total of 75 articles in peer-reviewed journals. These articles cover a wide range of topics involving pain, sedation and anesthesia, addiction medicine, and peripheral neuropathy; complete references can be found here.
September 14, 2017: ACTTION Presentations at Multiple Meetings
- Xueya Cai, PhD, ACTTION biostatistician, gave an invited presentation on "Multiple imputation for missing data in analgesic clinical trials using pattern mixture models" at the International Chinese Statistical Association Applied Statistics Symposium (Chicago, June 2017).
- Shannon Smith, PhD, ACTTION Assistant Director, will present a lecture on "Can we improve respondents' understanding of what should be the basis for pain intensity ratings? Evidence from the ACTTION PROTECCT training system" at the International Society for Quality of Life Research annual meeting (Philadelphia, October 2017).
- Robert Dworkin, PhD, ACTTION Director, is a member of the planning committee and will present a lecture on "Clinical perspectives on developing therapies to prevent the acute to chronic pain transition" and serve on a panel to evaluate the value of establishing "A US network for pain research" at the National Academy of Medicine-National Institutes of Health workshop on Advancing Therapeutic Development for Pain and Opioid Use Disorders (Washington DC, October 2017). He will also present a lecture on "The view from across the pond: we're going to need a bigger boat" at the Symposium on Clinical Pain Trials in Europe (London, October 2017).
- Jennifer Gewandter, PhD, ACTTION Assistant Director, will chair the "ACTTION-APS workshop for junior clinical investigators: opportunity to obtain constructive feedback on clinical research proposals" and a symposium on "Mechanism-based approach to clinical trial design in chemotherapy-induced peripheral neuropathy (CIPN)," at which she will present a lecture on "Design considerations for CIPN prevention trials: recommendations from an ACTTION-CONCEPPT consensus meeting."
September 8, 2017: ACTTION Submits Letter of Intent to FDA for Accelerometry
ACTTION has been assigned a Drug Development Tool number by FDA and submitted a Letter of Intent to begin development of the "Physical Activity Accelerometry Assessment for Analgesic Clinical Trials" (PAACT) and then apply for its qualification as a Clinical Outcome Assessment. ACTTION looks forward to the FDA's response and to developing an evidence-based and state-of-the-art approach for the assessment of physical activity using accelerometry.