Patients in fibromyalgia clinical trials are an interesting bunch. On one hand, you’ll seldom find a more accommodating and cooperative group of people. For years the condition was so poorly understood that many patients were treated dismissively by physicians who didn’t recognize fibromyalgia as a genuine affliction. And even today, the disease’s many symptoms continue to elude the reach of medical science.
Patients, especially those who have suffered for many years, are starved for research attention and thus highly compliant with their ePRO diaries. They really want you to know if they have experienced a 35 percent or 92 percent symptomatic improvement, or none at all.
On the other hand, we’re dealing with a complicated disease that has an incredible range of symptoms — literally 50 to 60 of them that can manifest themselves to various extremes throughout the duration of a trial. New patients will show up with a list of maybe 20 medications they’ve been using, and you’ll need to unravel those before starting patient screening that typically 45 percent will fail.
At a Town Hall Talk at the APS Annual Scientific Meeting in Pittsburgh, we looked at other complicating factors:
- This population has the potential to be more susceptible to placebo effect than is typical in analgesia studies.
- Fibro affects an estimated 4 percent of the population (that’s a lot of people), and it’s not uncommon for patients to also suffer from psychiatric disorders such as PTSD, bipolar disorder, and major depression — creating a perfect storm for pain and sensory amplification.
- With such a complex condition, even the subjects who qualify for your trial will have good and bad days.
Addressing what clearly remains an unmet need demands a careful approach to patient recruiting. When conducting the first generation of studies for fibromyalgia drugs, the industry seemed split on whether to recruit much beyond the known population. Active recruiting was seen, by some, as too chancy — too many potential comorbidities to cloud the waters — until a major pharma company competing with another to develop a fibro treatment recruited heavily and ended up beating its competitor to market.
For additional insight into this complicated disease from the CRO point of view, check out our APS presentation, Operationalizing Clinical Trials in Fibromyalgia.