With a tightening clinical trial marketplace and an increasingly stagnant per-patient value, study sites are under ever-greater pressure to find new ways to reach new subjects and satisfy some wary sponsors, says Christian Burns, a specialist in clinical site business development and patient recruitment with ClinEdge. The key is flexibility and recognizing new market segments.
For example, psychiatric trials have been booming for the last several years, but have begun to slow down. Flummoxed, leaders at sites with a heavy concentration on such trials find their specialized staff grappling with ways to adapt. Burns advocates finding areas of overlap, such as narcotic pain medicine trials. “In many cases, there is a component of pain” when working with trial patients suffering from depression or bipolar disorder. Sites can shift their strategy to include some of those patients without needing additional physicians because of that untapped overlap. It is more a case of finding new ways to leverage existing assets.
However, there are some instances where moving into a new market segment necessitates the hiring of a new principal investigator (PI), Burns notes. In those cases, it is critical to know how to identify and recruit the right kind of professional. Burns advocates several tools, including a “lunch and learn” presentation to be delivered to top candidates. A strong presentation should include:
- An overview of the site’s experience and reputation
- Highlights from innovative clinical treatments the site has had experience with and that would appeal to the prospective hire
- A clear discussion of what a site expects from a PI — “Most PIs don’t understand their role,” Burns says.
- Transparent discussion about study budgets — “Transparency is huge,” he stresses.
Sites must also confront the reality that, in many cases, their relationship with sponsors is frayed. Roche, Pfizer, and others have expressed frustration with sites that promise 50 test subjects and ultimately produce only 10, Burns says. To be fair to sites, he adds, sponsors more and more demand subjects applicable not just to a single condition (e.g., diabetes). Instead, they want a subject relevant to diabetes, severe heart disease, and hypertension.
Again, flexibility is key, Burns stresses, saying, “It’s about building a multispecialty site with more flexibility to adapt to change.”