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.
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President and Founder
Jae Chung is the president and founding visionary of goBalto. A startup evangelist, Chung wants to change the way pharma and CRO companies initiate clinical trials. goBalto's purpose-built study startup SaaS solution allows stakeholders to better adhere to established timelines and budgets, with customers reporting reduction in cycle times by 30-plus percentage, thereby getting medicines to those in need faster.
Chung works with Rock Health to mentor healthcare technology startups, and previously co-founded Celltrion (068270:KOSDAQ), a leading biopharmaceutical manufacturing company. Prior to Celltrion, he worked as a strategy consultant with McKinsey & Company.
In 2013 Jae was recognized as a FierceBiotechIT Top-10 Techie list and in 2010 was awarded the Bio-IT World Judges Prize for Technology Innovation. Jae has experience in drug development, commercialization, and business development. He has an MBA from New York University and holds a CPA.
Article originally published in The CenterWatch Monthly, December 2017