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 17, 2015: SF-MPQ-2 Now Available in 40 Languages
The development of the SF-MPQ-2 was sponsored by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), and the measure is now available in 40 languages. The SF-MPQ-2 has shown excellent reliability and validity in several independent studies, and there are four readily interpretable subscales – continuous pain, intermittent pain, predominantly neuropathic pain, and affective descriptors. The SF-MPQ-2 is suitable for diverse clinical studies, including clinical trials of treatments for neuropathic, non-neuropathic, and “mixed” pain conditions (for the initial publication, see Pain 2009;144:35-42; for recent references, see J Pain 2015;16:357-366). ACTTION and Dr. Ronald Melzack, who developed the MPQ and the SF-MPQ, share licensing fees from for-profit organizations using the SF-MPQ-2. Permission to use the SF-MPQ-2 can be obtained from the Mapi Research Trust (e-mail: PROinformation@mapi-trust.org; website: www.proqolid.com).
June 4-5, 2015: 18th IMMPACT Meeting on Data Quality a Success
The 18th meeting of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) was held on June 4-5, 2015 in Washington DC. The objective of the meeting was to develop recommendations for study execution and conduct that would ensure data quality in clinical trials of pain treatments. There were 51 participants from the US and Europe, representing academia, government agencies, industry, and patient advocacy organizations. There was a consensus among the participants that the issues that were addressed require continued attention and research and should be carefully considered in the design and execution of analgesic clinical trials. A manuscript is being drafted that will summarize the meeting discussions and present recommendations and research needs. The meeting agenda, background slide presentations, participant names and affiliations, and a complete meeting transcript will be available on the IMMPACT website in several weeks.
April 27, 2015: ACTTION Presentation at FDA Science Symposium
Kushang Patel, PhD, ACTTION Assistant Director, and colleagues presented a poster at an FDA Science Symposium describing ACTTION’s activities involving analyses of FDA clinical trial data. The complete reference for the presentation is: Patel K, Dworkin R, Gewandter J, McDermott M, Smith S, Turk D. Analysis of FDA clinical trial data to improve the assay sensitivity and informativeness of analgesic clinical trials. FDA 2015 Office of Regulatory Science & Innovation Science Symposium, Silver Spring, MD, April 27, 2015.