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.
December 17, 2015: Draft EMA Pain Guideline Cites Multiple IMMPACT/ACTTION Articles
The European Medicines Agency (EMA) has released an updated draft "Guideline on the Clinical Development of Medicinal Products Intended for the Treatment of Pain." The draft guideline references multiple IMMPACT/ACTTION articles that have presented recommended considerations for the design, analysis, and interpretation of adult and pediatric clinical trials of pain treatments. This important attention to ACTTION's efforts provides independent recognition of its contributions to advancing the development of improved pain treatments. The draft guideline is available here.
November 30, 2015: ACTTION Presentation at International Rare Diseases Research Consortium
ACTTION was invited by the International Rare Diseases Research Consortium to participate in a workshop on patient-reported outcome (PRO) measures. The purpose of the workshop was to raise awareness within the rare diseases research community about regulatory requirements for the development of PRO measures as well as to identify how the rare diseases community can expedite the development of PRO measures. Kushang Patel, PhD, ACTTION Assistant Director, presented an overview of ACTTION and discussed the potential benefits of public-private partnerships in the development of PROs for rare diseases. A publication of the workshop's proceedings and recommendations is currently in preparation.
November 10, 2015: ACTTION Presentation at National Academy of Medicine Forum on Neuroscience and Nervous System Disorders
The National Academy of Medicine Forum on Neuroscience and Nervous System Disorders held a session to explore the application of the Accelerating Medicines Partnership (AMP) to pain. The AMP is a public-private partnership between NIH, FDA, biopharmaceutical companies, and non-profit organizations to jointly identify and validate biological targets for the development of new diagnostics and therapeutics. Currently, AMP is supporting projects on Alzheimer's disease, type 2 diabetes, rheumatoid arthritis, and lupus. The Forum was interested in learning about the ACTTION public-private partnership and Kushang Patel, PhD, ACTTION Assistant Director, presented an overview of ACTTION’s mission, accomplishments, and ongoing activities. The Forum also received briefings from academic and industry investigators on current research on brain imaging and genetic and proteomic biomarkers of pain. Participants will continue to consider pain as a candidate condition for the AMP.