The U.S. Food and Drug Administration (FDA) and the University of Rochester have initiated a new public–private partnership to improve pain treatment called Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION; www.actionppp.org). The multiyear initiative aims to promote and accelerate the development of novel analgesics by identifying faults in the design of clinical trials.
Dr. Daniel J. Clauw, MD, professor of anesthesiology and medicine at the University of Michigan in Ann Arbor, says that there has been a “new perspective of pain developing” in recent years.
“The main change has been an increased appreciation of the role that central nervous system factors are playing in chronic pain, even in conditions such as osteoarthritis and rheumatoid arthritis, where we know that some of the pain is clearly due to peripheral damage or inflammation,” Dr. Clauw says.
Dr. Clauw, who is representing the ACR as a co-chair of the ACTION Executive Committee, notes that while new and possibly beneficial analgesics are being explored to treat acute and chronic pain, trial designs often prevent their development.
“We think that there are many trials [for analgesic drugs] that end up being negative or not showing the efficacy in the drug more because of issues of trial design—for example, high placebo response rate—rather than issues regarding the drug itself,” he says.
ACTION marks the first time the FDA will take lead of a pain research effort, which is ACTION’s “primary advantage,” according to Dr. Clauw. The FDA funded the program, will share its resources, and will initiate formal discussions between the involved parties.
Dr. Clauw expects these forums to establish a noncompetitive environment where data will be shared among stakeholders and any results of improved treatments will be presented to the public.
“The ACTION initiative is meant largely to be a neutral forum where academics, people from the agency, and people from industry can share ideas and data so innovative ideas about new trial designs and new ways of analyzing data might be able to get more drugs that work approved,” he says.
The initiative’s key objectives also include:
- Improving communication between public and private institutions (industry, professional organizations, academia, and government agencies);
- Organizing scientific workshops with experts in pain-treatment fields;
- And initiating methodologically focused research projects.
To remain self-sustaining and to achieve these goals, ACTION will raise funds from the pharmaceutical industry, foundations, and other public institutions.