The last several years have been an exciting time for pain research, as the tragedy of the U.S. opioid epidemic funneled attention and resources toward efforts to find new, non-addictive pain treatments. We’ve all seen the numbers, millions and millions of Americans with chronic pain, and few if any safe and effective treatments. There’s an old observation among researchers that common diseases are common until you try to study them, then suddenly there are no patients to be found.
At the PAIRED Project we’re part of a nationwide consortium for pain clinical trials called EPPIC-Net and recruiting patients to be in our first two clinical trials, one for knee osteoarthritis and one for diabetic peripheral neuropathy, has been a challenge. But like any challenge it’s also an opportunity to learn and we’ve been thinking a lot about why this has been so hard and how we can do better.
For our HIV-focused studies, like EVA and SALUD, recruitment has been much easier. Maybe understanding why would help us with our pain studies. Well first of all, it’s a different disease. HIV has a moving history that’s inspired books, movies, and musicals. It also has a legacy of vibrant and persistent advocacy. On World AIDS Day last year, when members of our team joined VOCAL-NY activists near the Stonewall National Monument, a chant broke out: “When people with AIDS are under attack, what do we do… Standup, fight back!” For many people living with HIV, the HIV is a part of their identity. There are a lot of conditions like that, they’re usually the ones that have associations, walks, challenges, ribbons, recognizable abbreviations (like MS, ALS), maybe a celebrity or two. These same conditions also tend to have medical homes, clinics devoted to the care of those patients’ specific needs. Since the beginning of our careers we have been a part of meeting these needs for people living with HIV. Dr George is our veteran, she was even there for the first HIV treatment trials. So when a new HIV study comes up, it’s easier to ask the community to participate when there’s a history of trust built over time.
But what if there’s less history, and less of a clearly identifiable community? Chronic pain isn’t a single, defined disease like HIV. It hasn’t been a rallying cry or a reason to march. It’s an experience common to many disorders, including the ones we’re trying to study, knee osteoarthritis and diabetic peripheral neuropathy, but also many others. From a drug development perspective, especially in the early stages, it makes a lot of sense to think of chronic pain disorders in aggregate because their treatments tend to overlap, a drug that works for diabetic peripheral neuropathy pain is likely to also work for fibromyalgia. But drug development requires people to participate in clinical trials, and from a recruitment perspective chronic pain as a disease focus is very tricky.
Why? Well, recruitment to any research study can be thought of as the process of finding interested and eligible patients. Eligibility is pretty straightforward and controllable. The researcher writes the inclusion and exclusion criteria for the study and could always change them if they are too strict. Many research studies are conducted in large health systems with electronic health records that (with appropriate privacy protections in place) could be programmed to produce lists of patients that meet a set of criteria.
Interest, however, is much more complicated. Why might a person want to participate in a clinical trial? Maybe they want access to a new experimental drug that they couldn’t get otherwise. For very serious or potentially fatal diseases (cancer, ALS) access makes sense as the main driver. But what about when your life is not in immediate danger from your disease, what if instead you are long suffering neither better nor worse from month to month, from year to year. Why participate in a study, especially now when the energetic barrier to get out and participate in anything seems so much higher than it did before?
As a pain research community we desperately need good answers to this question. Chronic pain needs a story that inspires books, movies, and musicals. It needs to go viral. Then we and our research participants could be characters in the narrative of how this terrible condition was ultimately conquered. The story of chronic pain can be compelling, but it requires creativity to tell well. Perhaps it is a story of how a universal experience that is one of our most basic defense mechanisms, something we all need to survive, can turn on us… a story of chronic pain as an allegory.
EPPIC-Net’s mission is critical, we must learn how to sustainably bridge the gap between early drug development and the large clinical trials that ultimately lead to the approval of new pain medications. At the conclusion of one investigators’ meeting, then NIH director Francis Collins sang a folk song, “If not now tell me when.” One line in this song is: “Although there will be struggle we’ll make the change we can.” We make change by performing the research, but also by telling its story.