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.
June 26, 2015: ACTTION to Qualify New Pain Intensity Outcome Measure
The FDA has completed review of ACTTION’s Letter of Intent to pursue qualification of a patient-reported outcome measure of acute and chronic pain intensity and has agreed to enter this project into the Clinical Outcomes Assessments Drug Development Tools qualification program. The development and validation of this new measure – Qualified for Therapeutic Evaluations of Pain (QUALITE-Pain) – will be a multi-year undertaking and will begin with qualitative research in different pain conditions and in adult and adolescent patient populations in order to determine the appropriate context of use for QUALITE-Pain. Shannon Smith, PhD, ACTTION Assistant Director, will be spearheading this major initiative and will be establishing a new ACTTION Working Group to oversee the development of QUALITE-Pain.
September 21, 2015: Second International Conference on Accelerating the Development of Enhanced Pain Treatments (ADEPT-II)
ACTTION will sponsor the Second International Conference on Accelerating the Development of Enhanced Pain Treatments (ADEPT-II) on June 15-17, 2016 in Washington DC. This meeting will be devoted to the design, execution, analysis, and interpretation of clinical trials of pain treatments and will focus on important advances that have occurred since the successful ADEPT-I meeting held in Bermuda in March 2011. The intended audience is investigators in academia, industry, and government who are involved with any of these aspects of clinical trials of pain treatments. The impetus for the meeting is the lag in the development of analgesic treatments with improved efficacy and safety, coupled with the shortage of junior investigators with knowledge of the issues involved in the successful design and conduct of analgesic trials. The meeting will begin with a half-day session on preclinical and translational pain research, which will be followed by 2 full days on the design, execution, analysis, and interpretation of analgesic trials. Because a range of experience among the participants is expected, morning plenary sessions will be followed by parallel afternoon introductory and advanced tracks. ACTTION will offer 10 fellowships for junior investigators to attend the meeting that will cover all of their travel and registration expenses. The members of the ADEPT-II Steering Committee are Ralf Baron, MD, PhD; Allan Basbaum, PhD; Robert Dworkin, PhD; Sharon Hertz, MD; Troels Jensen, MD, PhD; Nathaniel Katz, MD; Allison Lin, PharmD, PhD; Srinivasa Raja, MD; Michael Rowbotham, MD; and Dennis Turk, PhD.