Human Factor Looms as Significant Hurdle to Expanding Virtual Trials

Michelle Shogren, Director of Innovation with Pharma R&D Clinical Operations for Bayer

As an industry professional, you may be fired up about the wonders promised by virtual trials. You’re jazzed by the prospect of expanding care to underserved patient populations and remote parts of the country. You can’t wait to get innovative new products to market more safely and efficiently.

Great. Now it’s time to convince the skeptics, said panelists for a session, “Enhance the New Model of Clinical Trials by Considering the Importance of Behavior Change,” at the Direct-to-Patient Clinical Trials conference held by CBI in Philadelphia this week.

“We don’t think enough about the psychological behavior change” required for patients and clinical trial front-line professionals to embrace new ways of doing things, said Michelle Shogren, Director of Innovation with Pharma R&D Clinical Operations for Bayer.

“There’s no one-size-fits-all approach,” Shogren admitted. “You can’t just assume one plan for sites and one for internal operations, for example.”

Advocating this kind of significant paradigm shift in how some clinical trials are conducted is a “big ask,” agreed Tiffany McGinnis, U.S. Country Head of Site Management for Bayer. For McGinnis, the most effective approach is to remember that everything should be about putting patients first. “You have a lot of different stakeholders [in virtual trials], but number one is it goes back to the patient,” she said. “Ask them [what they think], and bring that information into your organization and do something with it.”

However, patients aren’t the only factor to consider. “I underestimated the importance of [internal] change management [at Bayer]” as the organization explored virtual trial options, McGinnis said. “You have to meet people where they are on their own change management journey.”

Calling herself a big fan of change and finding new ways of confronting challenges, McGinnis allowed that many others are less enamored of change. “Some people feel stressed and anxious,” she noted. Others won’t engage in a meaningful way until they “see what’s in it for them,” she added.

And don’t sugarcoat the landscape of trying new things. “Change is extra work,” McGinnis said. “There’s no way around it.”

Lest she appear pessimistic, McGinnis reported change management and time have worked in her favor at Bayer. After about a year of discussions, internal study teams are approaching her team in the hopes of being considered as early adopters for virtual trial–related projects.

Author: Michael Causey