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Why Sponsors May Be ‘Asking the Wrong Questions’ When Choosing Trial Sites

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New breakthroughs in AI and personalized vaccines are redefining oncology research. Has our definition of what a successful trial site looks like kept up? In an article for Fierce Healthcare, Marcy Kravet argues that sponsors often still look for the wrong things in site selection, increasing site underperformance and lack of diversity in trials.

Instead, “[s]ponsors need to retire the current definition of what makes a site a ‘good site’ and bring forth a willingness to look to lesser-known, but experienced and motivated, sites for their trials.”

I spent over 15 years at large pharmaceutical companies witnessing the site selection process become more and more data driven. During that time, I led feasibility teams, owned the company SOP on country and site selection, and worked with clinical operations personnel to ensure local intelligence on standard of care and practice patterns were considered in site selection decisions. Across these roles, the common goal was finding the right sites to bring in the right patients who needed access to care, yet our system for identifying motivated, qualified researchers reduced sites to data points.

When selecting sites based on historical data and feasibility responses, large sites with extensive industry experience have the advantage. However, many of these top-tier sites still struggle to perform as more trials are launched, even as they remain the first choice for sponsors working in the same indication.

“Progress requires sponsors to funnel their innovation into rewriting the definition of a good site,” says Kravet. “It calls for a shift away from antiquated data sets and towards a novel approach that promotes tier-three sites from the bottom of the list, recognizing the power of communities.”

Read the full article here

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