Charles Legg is Vice President of Life Sciences for North America at Clinithink. Before Clinithink, he spent over two decades leading cross-functional clinical development teams at pharmaceutical and biotechnology companies. An experienced executive and entrepreneur, Charles’ motivation to come to Clinithink stems from his belief that the company’s AI software meets a critical unmet need: the necessity for a faster, more efficient way to match patients with clinical trials.
Q: As a life science executive in clinical development, what were some of your primary challenges?
A: As a senior executive involved in clinical development , the ultimate challenge was to find ways to increase speed to market and manage spend vs. risk along the way. This meant optimizing protocols, selecting the right sites, finding qualified patients and demonstrating statistical significance for our products. With electronic health record systems, researchers now have large patient datasets containing extraordinary amounts of information. The challenge is how to mine this data. It’s fair to say, the promise has not lived up to the hype. Until now.
Q: What got you interested in Clinithink?
A: I saw that Clinithink had put a lot of thought and rigor into creating and developing software that would disrupt the industry. The reason is they recognized most of the valuable information in electronic health data is in narrative free text, not structured data. Clinithink’s CLiX ENRICH can “read” thousands of clinical documents an hour and extract the information they contain. When I first saw CLiX ENRICH in action, it was apparent how powerful it was. Existing technologies rely on structured data or key word searches. These can be helpful, but aren’t game changing. The bulk of pre-screening and site feasibility work is still manual review. CLiX ENRICH largely automates this process and targets very specific patient inclusion/exclusion criteria, even down to specific start and stop events, varying dose levels and thousands of other variable criteria. Currently these can only be found through laborious manual search.
[av_two_third first]Q: How does Clinithink save time and money during the clinical trial process?
A: Our software speeds up clinical trials, optimizing the development process along the entire continuum – site selection, protocol optimization and enrollment. The net effect - significant de-risking for the program and potentially significant savings in development time by decreasing the total enrollment time, reducing protocol amendments, improving data robustness for the next development stage, etc. Time’s a big factor in a program’s cost and even more important for patients waiting for an important new therapy. E.g. a sponsor looking to identify and contract with sites will rely on site investigators and their teams to approximate the number of site patients, but this requires guesswork especially when complex inclusion/exclusion criteria are involved. It’s fairly common down the road that some of those patients don’t materialize. In fact, more than 80% of trials fail to meet enrollment timelines, and nearly 50% of sites enroll one or no patients. With CLiX ENRICH, you can identify in advance, sites with the greatest number of patients matching a trial’s criteria. Removing/reducing that level of uncertainty is a big deal.
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[av_one_third]“Picking clinical sites can be a challenge. A variety of factors that must be considered, but certainly an important one is whether there are enough qualifying patients to justify opening a site. With CLiX ENRICH sponsors can identify sites with eligible patients before making a commitment."[/av_one_third]
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Q: Will artificial intelligence replace KOLs?
A: Absolutely not. KOLs and site investigators are the ones responsible and most qualified to determine which patients to recruit. However, investigators don’t have the time or manpower to manually review many thousands of pages of patient data every time it would be helpful. Clinithink automates 95% of this process, providing a powerful tool for investigators and freeing up precious time for site staff.
Q: Any last thoughts to leave us with?
A: I believe that the application of AI to clinical trials exemplifies a true technological breakthrough for the life science industry. There‘s an ongoing debate in the industry about how to improve the efficiency of innovation and drive down the average cost of clinical development. I think Clinithink are a piece of the solution which is why I’m so excited to have joined them.