“It’s an interesting dance we do, right?” That’s Jane Jacob, PhD, vice president for research and clinical affairs with Orthofix, on the sometimes-fractious relationship between sites and sponsors. “There’s a lot of misunderstanding on both sides,” she says, “but we have the same pain points,” such as budgeting, protocol development, and monitoring.
“We’re supposed to work together because our goal is to get a new drug or new device approved on the market,” Jacob says. Unfortunately, wary site leaders sometimes misunderstand, or sponsors aren’t clear enough, when it comes to capabilities and expectations.
In a best-case scenario, the relationship between site and sponsor is solid enough for both sides to view reasonable mistakes as learning opportunities—not finger-pointing exercises.
Jacob has a message for site leaders who are afraid to “admit” they can’t do something, fearing it will scare the sponsor away for good: “I would much rather have that candid discussion up front and [applaud] them for recognizing it isn’t going work” in a particular instance. “I love to see what other kinds of expertise the site has, because I’m always thinking ahead” to studies coming down the road that might be better suited for the site, she adds.
You Want Me to Do WHAT? Building Lasting Sponsor/Site Relationships Part Deux
Join Jane Jacob of Orthofix and the Spine Institute of Louisiana’s Dr. Marcus Stone and Kelly Van Shouwen (Frank) at ACRP 2019 this April to explore effective ways of building lasting sponsor/site relationships. Back for 2019, this popular, interactive session will help you identify a framework that builds a successful relationship beyond a single research project.
“I get suspicious when somebody says they can do everything,” Jacob says. “A site will tell me they can get 500 rotator cuffs [patients] a year. Well, how many meet our major criteria? Maybe 100. Then we get down to the nitty gritty” and the site leaders can’t come up with anywhere near the 500 figure they bandied about at the courtship stage.
She also cautions against overenthusiastic principal investigators (PIs). “Doctors really always say, ‘yes, yes, sure I can do that,’ but it’s the people working at the site—the research director, the study coordinators—who will know there’s no way” they can come up with the numbers promised by the PI, Jacob says.
Author: Michael Causey