Flawed Trial Negotiations Can Catch Site Newcomers Off-Guard

Marcus Stone, PhD, CEO, Spine Institute of Louisiana Foundation

Marcus Stone, PhD, CEO, Spine Institute of Louisiana Foundation

Study site leaders who are new to the business of conducting clinical trials are sometimes “naïve” and hesitant to ask probing questions as they work with sponsors to define study parameters at the outset, says Marcus Stone, PhD, CEO of the Spine Institute of Louisiana Foundation.

“First, there is some fear of losing the business,” Stone acknowledges. However, that’s not the main reason for the disconnect between sites and sponsors. Instead, he blames high rates of site turnover. “They don’t even know what questions to ask, they get down the road and [struggle], and this is one of the problems with why maybe they don’t choose to do another study.”

Another problem: sites that treat trials as something of a side business. “They don’t have dedicated research staff, but they’ve set aside time maybe for a nurse or [a few other staff],” Stone says. In some cases, personnel set aside 25% of their time to do research, and they just don’t know how much time it really takes to do quality work, he adds.

Practical Strategies for Building Lasting Relationships Between Sponsors and Sites – Join Stone at ACRP 2018 to hear practical tips for preventing sponsor-site relationship challenges and solutions for resolving them when teamwork is compromised. Stone and fellow presenter Jane Jacob, PhD, Vice President, Research and Clinical Affairs, Orthofix, will also highlight key communications between sponsors and sites. View Session Details

Sponsors should also be wary of a site that agrees to everything too quickly, Stone warns. It’s not about sites being disingenuous so much as it is about not thinking through the actual work required. For example, a sponsor might send a Clinical Trial Agreement template to the site, and the site takes a cursory look, signs it, and returns it to the sponsor. If sites aren’t asking questions—if there isn’t any pushback during the negotiating phase—sponsors “probably should look at what’s going on,” Stone advises.

While Stone doesn’t see the trend necessarily increasing, the issue isn’t likely to go away anytime soon, either. As the industry feels the crunch of fewer new drugs and devices coming out, and increased scrutiny on timelines and costs over entire studies, he says “it’s compressing everything and building up that pressure” to get studies done as quickly and efficiently as possible without clear understanding on both sides.

Author: Michael Causey