IBM Watson Health’s Study Advance is designed to help optimize design of clinical trial protocol. It includes protocol template guidance and allows for collaboration across its cloud-based workspace.
Data by design
Rob DiCicco, deputy chief health officer for IBM Watson Health, told Outsourcing-Pharma that study design improves vastly when patient data is incorporated at the outset—and when the right personnel are invited to collaborate early on.
“By the time the people that actually do things impacting the study are brought into the process, it’s gone a mile down the road,” he said. “We’re trying through this collaborative platform to bring all those relevant groups to the table—to see what’s happening to the design and influence in a way that optimizes it.”
DiCicco added that moving the application of data 'upstream' in protocol design streamlines the process and helps avoid error, amendments and other challenges.
According to the company, just one protocol change in a Phase III clinical trial could add $500,000 (€437,300) in expenses and two months to the project timeline. Study Advance is intended to enable trial staff to access data that delivers critical insights at the design stage. The end goal is a reduction in the number of amendments during trials.
Patient information access
The Study Advance interface provides access to commercial and claims data from de-identified profiles of approximately 89 million patients. These are derived from multiple employer-sponsored US healthcare beneficiaries. It also includes paths to determine inclusion/exclusion criteria on the eligible patient population.
Additionally, the platform’s workspace is engineered to permit near-real-time collaboration with study design team members, who are able to assign staff to specific protocol sections. Version control capabilities allow traceability of changes, which the company said serves to cut down the average time it takes to author a clinical trial protocol.