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Why is there such inefficiency in site selection?

Thursday, December 15, 2016

This question is often asked about an industry deeply root­ed in paper-based, spreadsheet tools for clinical trial conduct. Study teams have continued to rely on these older tools and relation­ships with principal investigators that have developed over time to select sites, building an institu­tional knowledge about specific sites based on previous studies.

While these methods seem logi­cal, they lack verification, trans­parency and are slow, taking 3.2 months, on average, to go through the site selection process. Unfortu­nately, institutional knowledge is frequently dated and siloed within departments, and may not be rel­evant to the therapeutic area un­der investigation. Moreover, study teams are blinded to problems in­herent with this approach—name­ly, it limits opportunities to engage with new sites that could be more effective than those familiar to the study team.

For a typical multicenter study, 30% of sites selected are new, mean­ing they would not appear in ex­isting spreadsheets, thereby un­dermining the value of the older approach. With the increasing complexity of clinical trials, con­tinued reliance on older methods has resulted in various industry ini­tiatives designed to fuel widespread adoption of technology meant to improve clinical trial operations.

Purpose-built technologies uti­lizing multiple data sources provide sponsors and CROs with a data-driven approach to selecting sites most likely to enroll patients on time and on budget. This actionable intelligence removes the blinders inherent in older methods, leading to a more thoughtful and analytical method. This advances the process from identification and feasibility through to site activation.

 

Written by Guest Writer Jae Chung. Chung is the founding visionary of goBalto. A startup evangelist, he works with Rock Health to mentor healthcare technology startups. He previously co-founded Celltrion, a leading biopharmaceutical manufacturing company and was a strategy consultant with McKinsey & Company.

This article was reprinted from Volume 23, Issue 12, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>

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