Analgesic Clinical Trials Innovation, Opportunities, and Networks (ACTION) Initiative
Public Health Context:
Despite the enormous advances in drug development over the past two or three decades, (e.g., drugs that cure cancer, biologic drug products that halt the progression of rheumatoid arthritis), the development of novel analgesic drug products has lagged behind. Indeed, to this day, the only analgesic drug products that are used widely and successfully are opioids, acetaminophen and the non-steroidal anti-inflammatory agents (NSAIDs), all of which have serious, potentially life-threatening toxicities, even when used properly. While there has been exploration at the earliest stages of drug development, there has been wide-spread reluctance on the part of the pharmaceutical industry to take novel products further into development. This is in no small part due to the often daunting task of demonstrating the efficacy of analgesics in clinical trials. Many experts in analgesic drug development believe that it is the design of the clinical trials that is at fault in this situation, and that better trial designs will yield more successful results. This hypothesis is certainly supported by the frequent failures of clinical efficacy trials of opioid drug products, considering the well established effectiveness of these products from literally thousands of years of clinical experience. For these reasons, additional studies are needed to assess the confounding nature of analgesic clinical trials and analgesic drug development.
The Analgesic Clinical Trials Innovations, Opportunities, and Networks (ACTION) Initiative is being designed as a PPP for two key purposes. First, to initiate and foster strategic collaboration amongst a broad spectrum of stakeholders, including, but not limited to, industry, academia, professional organizations, patient advocacy groups, and other Government agencies with the well-defined goal of sharing data, best practices, and innovative thinking. Second, under the auspices of the ACTION Initiative, it is anticipated that these stakeholders will leverage their resources (e.g. data, scientific expertise, infrastructure, and financial resources) to foster dialog and develop specific projects that will add to the body of information so that analgesic drug development can be moved forward in an expedited and efficient manner.
Mission & Program Objectives:
The ACTION Initiative aims to streamline the discovery and development process for new analgesic drug products for the benefit of the public health. This multi-year, multi-phased Initiative will address major gaps in scientific information which can slow down analgesic clinical trials and analgesic drug development. Key objectives include:
- Establishing a scientific and administrative infrastructure to support a series of projects;
- Establishing relationships with key expert stakeholders, industry, professional organizations, academia and government agencies;
- Coordinating scientific workshops with key experts in the field of anesthesia and analgesia;
- Conducting in-depth and wide-ranging data analyses of analgesic clinical trial data to determine the effects of specific research designs and analysis methods.
The ACTION Initiative Public-Private Partnership(PPP) is being implemented by the University of Rochester’s Center for Human Experimental Therapeutics in cooperation with the U.S. Food and Drug Administration (FDA). As a 501(c)(3), the University of Rochester serves as a recognized and respected neutral third party convener.
The University of Rochester, with support from the FDA through a contract under the Critical Path Initiative, provides a Director, Associate Director and staff who manage the ACTION PPP, coordinate planning and implementation of all projects, provide financial oversight and establishment of a process for identification, prioritization, and development of potential projects.
U.S. Food and Drug Administration
University of Rochester
University of Pennsylvania
American Academy of Neurology (AAN)
American Academy of Pain Medicine (AAPM)
American Pain Society (APS)
American Society of Anesthesiologists (ASA)
Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)
International Association for the Study of Pain (IASP)
Outcome Measures in Rheumatology (OMERACT)
- Advancing Regulatory Science for Public Health
- Rappaport BA, Cerny I, Sanhai WR. ACTION on the Prevention of Chronic Pain after Surgery: Public-Private Partnerships, the Future of Analgesic Drug Development. Anesthesiology 112(3), March 2010, p509-510
- Dolgin E. Fluctuating baseline pain implicated in failure of clinical trials. Nature Medicine 16(10) Oct 2010, p1053
- Federal Business Opportunities link to ACTION contract announcements