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.
October 17, 2014: Thirteen ACTTION Articles Published or Accepted Since January 1, 2014
The following ACTTION articles have recently been published or accepted for publication (see May 22, 2014 news item below for this year’s first set). These articles cover a range of topics, and abstracts are available at the link provided at the end of each reference.
Gewandter JS, McDermott MP, McKeown A, Smith SM, Williams MR, Hunsinger M, Farrar JT, Turk DC, Dworkin RH. Reporting of missing data and methods used to accommodate them in recent analgesic clinical trials: ACTTION systematic review and recommendations. Pain, 2014;155:1871-1877. (abstract here)
Dufka FL, Dworkin RH, Rowbotham MC. How transparent are migraine clinical trials? RReMiT Repository of Registered Migraine Trials. Neurology, in press. (abstract here)
Dufka FL, Munch T, Dworkin RH, Rowbotham MC. Results availability for analgesic device, CRPS, and post-stroke pain trials: comparing the RReADS, RReACT and RReMiT databases. Pain, in press. (abstract here)
Dworkin RH, Turk DC, Peirce-Sandner S, He H, McDermott MP, Hochberg MC, Jordan JM, Katz NP, Lin AH, Neogi T, Rappaport BA, Simon LS, Strand V. Meta-analysis of assay sensitivity and study features in clinical trials of pharmacologic treatments for osteoarthritis pain. Arthritis & Rheumatology, in press. (abstract here)
Gewandter JS, McDermott MP, McKeown A, Smith SM, Pawlowski JR, Poli JP, Rothstein D, Williams MR, Bujanover S, Farrar JT, Gilron I, Katz NP, Rowbotham MC, Turk DC, Dworkin RH. Reporting of intention-to-treat analyses in recent analgesic clinical trials: ACTTION systematic review and recommendations. Pain, in press. (abstract here)
Gewandter JS, McKeown A, McDermott MP, Dworkin JD, Smith SM, Gross RA, Hunsinger M, Lin AH, Rappaport BA, Rice ASC, Rowbotham MC, Williams MR, Turk DC, Dworkin RH. Data interpretation in analgesic clinical trials with statistically non-significant primary analyses: An ACTTION systematic review. Journal of Pain, in press. (abstract here)
Hunsinger M, Smith SM, Rothstein D, McKeown A, Parkhurst M, Hertz S, Katz NP, Lin AH, McDermott MP, Rappaport BA, Turk DC, Dworkin RH. Adverse event reporting in non-pharmacologic, non-interventional pain clinical trials: ACTTION systematic review. Pain, in press. (abstract here)
September 29, 2014: ACTTION Awarded 3-year Contract and Increased Cooperative Agreement Funding from FDA
ACTTION was awarded increased funding for Year 4 of its 5-year cooperative agreement, and was also awarded a 3-year contract from the FDA to conduct analyses of patient-level data from analgesic clinical trials submitted to the FDA. These analyses will focus on statistical aspects of analgesic trials, such as the accommodation of missing data, as well as the development and validation of composite outcome measures of pain and physical functioning and pain and rescue analgesic use. The inspiration and impetus for ACTTION was provided by the FDA, and the ongoing support of the agency has been essential to ACTTION’s success and accomplishments.