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 email@example.com. Subscribe >>