Rushing Site Selection in Fibromyalgia Trials, Not a Great Idea

In the early days of fibromyalgia drug research, trial site selection centered almost exclusively on rheumatologists and pain centers. But with more drugs on the market and still more studies underway, there has been significant expansion in the number of sites equipped to conduct this research.

Up to a point, anyway.

As fibromyalgia therapy matures, general practitioners have access to growing patient databases and benefit from exposure to new medications. Sites capable of conducting these trials now number in the hundreds, but — make no mistake — not all are equal in their ability to navigate this complex and ever-evolving indication.

Picking the right sites is among our most critical responsibilities as a CRO, and here are a few of the things we consider:

  • In addition to pain management, the site must understand patient psychiatry and placebo response. The placebo effect can quickly torpedo any analgesia trial, and it’s typically more pronounced in fibromyalgia studies.
  • Many sites may appear equally qualified on paper, but staff quality can vary over time and from project to project. Collect all the current feedback you can find — or proceed at your peril.
  • Most sites you consider should have a database of fibromyalgia patients available by As an industry, we’ve been at this long enough that any site claiming expertise in this field should have a growing cadre of patients they know to be reliable.
  • You should not only assess any other fibromyalgia studies the site is running, and their potential to divert patients from your project, but also other competing trials and staff availability, regardless of indication. A site that can’t commit sufficient resources will kill your trial in a hurry.

Data integrity is crucial as well. Anyone who has ever invested in securities knows the Wall Street truism that past stock performance does not predict the future, and the same applies in clinical research. This business is synonymous with high turnover, so you must continually look at the quality and timeliness of site data as a critical gauge of performance.

You also want to ensure that any site you consider is open to working with central recruiting agencies, because while there is no shortage of fibromyalgia patients, not all patients make good subjects.

It’s hard to overstate the importance of thorough and thoughtful site selection, and it’s among the subjects we addressed in our Town Hall Talk at APS in Pittsburgh. Check it out!