June 24, 2024

Pharma’s Almanac

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Rich Gliklich, M.D., Chief Executive Officer and founder, OM1

One impactful way will be through platforms that enable data and study automation. In recent remarks, FDA Commissioner Dr. Robert Califf argued that there is tremendous opportunity to simplify and digitize data collection to create more pragmatic and less burdensome approaches to evidence generation: “Technology is no longer our limitation.”

The automation of data collection, from electronic medical records and other systems, is emerging as a key means to simplify and improve clinical studies. Some of the advantages of automation include accelerating study timelines, reducing costs, generating external control arms, reducing site burden, and increasing the diversity of participants who are enrolled.

Validated systems, such as OM1’s automated study platforms, collect and process data directly from electronic health records for clinical studies from hundreds of practices and health systems. This includes the traceable and auditable transformation of unstructured clinical narratives and reports into standardized data points and using AI to identify computable phenotypes and to estimate and amplify key outcomes. These platforms are significantly changing the burden and costs of registries, large studies, and external control arms to name a few. By showing measurable benefit and ROI in evidence generation, technology providers can help the industry digitize data collection.