Pain is the most common symptom leading patients to see a physician in the U.S., yet the most widely prescribed medications such as opioids and non-steroidal anti-inflammatory drugs have major drawbacks including the potential for misuse and adverse effects that limit long-term use.
In response to this public health need, FDA has signed a partnership agreement with the University of Rochester Medical Center with funding of $ 1 million to launch the “Analgesic Clinical Trial Innovations, Opportunities, and Networks” (ACTION) initiative.
In addition to the University of Rochester, researchers from associations, NIH, the U.S. Department of Veterans Affairs, patient advocacy organizations, and pharmaceutical companies are all going to participate in the FDA-University of Rochester Partnership.
The initiative is designed to streamline the discovery and development process for new pain-reducing drug products. This multi-year multi-phased initiative will address major gaps in scientific information that can slow down analgesic clinical trials and analgesic drug development.
“One of the issues with pain is that it cuts across so many specialties such as anesthesiologists, rheumatologists, emergency department physicians, and others that are all interested in pain”, said Denham Ward, M.D., PhD, Chair of the Department of Anesthesiology at the University of Rochester Medical Center.
In the U.S., there is a major lag in new treatments for pain but this is not due to a lack of potential medications. A multitude of studies testing experimental therapies have been conducted or are underway. The problem is that many trials fail because they are unable to show that a new medication provides greater pain relief than a placebo.
Although some drugs under investigation may have little or no effectiveness when it comes to minimizing pain, researchers believe other factors may play a role in the disappointing results of the many recent studies. The fact contributing to the problem is the way that pain clinical trials are designed and carried out may hinder or limit their ability to distinguish truly effective pain treatments from less effective treatments.
“Clinical trials come at a great cost, take substantial amount of time to carry out, and require significant effort from the patients who participate,” said Robert Dworkin, PhD, Professor in the Department of Anesthesiology and the Center for Human Experimental Therapeutics at the Medical Center and Director for the new FDA-university initiative. “We need to understand why so many pain studies have failed to show efficacy so we can make changes that will increase the likelihood that future studies will identify new treatment options for patients who are suffering”.
The partnership will analyze a wide range of clinical trials of treatments for acute and chronic pain and look specifically at the approach and procedures used in each trial. Researchers hope to identify problems or gaps in trial design and implementation and find ways to bridge these gaps to speed the development of new safe and effective medications.
According to Robert Dworkin PhD, Director of the ACTION Initiative, “An effective therapy may fail to show significant pain relief in a study because the optimal patients were not enrolled or the research design and methods had important limitations. There is a whole range of things that can lead to falsely negative study results, and the goal is to determine what they are and what can be done to modify them in future studies.”