In this video interview with ACT editor Andy Studna, Rich Gliklich, founder of OM1 discusses automating data collection and organizing unstructured data.
ACT: Is there any potential for the use of artificial intelligence (AI) in the data collection space?
Gliklich: I love that question because we literally power our data automation and data collection with AI in multiple ways. It starts with automating data mapping and quality assurance. When we bring data in from a medical record system or a laboratory information management system, we need to bring that into a common data model by leveraging generative AI, we can do that much faster and then verify it. Where we see its greatest benefits today are in collecting and transforming unstructured data, like clinical notes, imaging reports, pathology reports, procedure reports, into structured variables, so capturing MRI lesions or symptoms, those are areas that we're using today at scale. We still have to go and validate it with extractors to demonstrate, at least in a sample, that it's doing the right thing. That's one area. Another area that we find really exciting is the concept of using clinical narratives for generating estimated or surrogate endpoints, so estimated endpoints, or surrogate endpoints, as you know, can speed a trial or make more patients useful in a trial, and we can derive those from the medical record patterns that we see using AI or from an estimation.
We'll take a clinical note, and we will use patients where or visits where a measurement has been recorded, and those where it hasn't been recorded, and the system will actually read the clinical note, it's almost magical, and estimate an endpoint from that. We validate many of those and I was using some examples from lupus, the SLEDAI as an example, because it's used in clinical trials, but it's only used in like 5% of practice in the clinical world; 5% of encounters, so it's incredibly valuable to be able to do that. Those are some of the areas where we see value and data collection.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.