Human Factor Key to Successful Clinical Trial Operations

Cynical, cigar-chomping baseball managers or jaded political campaign hacks might disagree, but nice guys (and women) definitely don’t finish last when it comes to working on clinical trials.

Fresh off a survey of 23 active enrolling sites, that message is coming through loud and clear to Mary Sophy Yohannan, MBBS, CCRC, a clinical research associate with Boston Scientific.

“I asked a lot of the coordinators and managers, ‘If you could only pick one quality in a sponsor or monitor, what would it be?’” Yohannan says. If you guessed piles of money, fancy tools, or other goodies, you’d be wrong. The answer? “Somebody who’s personable,” she says. “Somebody who first and foremost acts like a human being and not a robot with a checklist…somebody who can speak to them to find out what’s really going on at the site.”

Each side will benefit from meaningful, two-way conversations, Yohannan says. “Each site is unique and has its own unique capabilities and difficulties,” she notes. “A lot of monitors and site representatives don’t seem to understand that.”

Building Relationships and Collaboration: Sponsors and Sites

Join Boston Scientific’s Marian Fisher and Mary Sophy Yohannan this April at ACRP 2018 for a lively discussion of site / sponsor relationships. Learn strategies for collaboration and relationship building based on feedback from high-performing sites.

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Too often, she adds, sponsors “write the protocol based on the idea that every site has the same ability. [But there] has to be some flexibility in the way we monitor and the way we interact with the site as a supportive team, based on their capability.”

So-called soft skills, such as empathy and communication, are increasingly important in an environment where, for most investigators and site personnel, “the major draw toward the clinical trial is the prestige,” Yohannan says. “They’re looking to offer their patients more than standard of care, and they want to be part of a community that is invested in cutting-edge research, cutting-edge devices, and cutting-edge treatments for their patients,” she adds. “They want to be involved, to be part of the solution, and they want their voices to be heard.”

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Sponsors sometimes forget “investigators are putting not only their reputation, but also their job on the line to enroll these patients and follow them for safety,” Yohannan says. But she feels it’s up to sponsors to make investigators feel like a valuable part of the team, and explains that investigators “should feel like they can speak up about what’s happening and offer up ideas for ways to improve the protocol, or the data collection or safety reporting.”

Author: Michael Causey