By Clinical Research News Staff  

February 18, 2020 | ORLANDO--IBM Watson Health (NYSE: IBM) today unveiled its newest cloud-based technology, IBM Study Advance, at the 11th Annual Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida. The data-driven study design and authoring tool optimizes clinical trial protocol design by merging automated access to real-world patient population data, standardizing protocol template guidance and providing a collaborative workspace designed to facilitate efficiency.  

On average, a single protocol amendment to a Phase III clinical trial can result in approximately $500,000 in unplanned expenses and add 61 days to the project timeline. IBM Study Advance offers critical insights during the process of study design to reduce the number of amendments during clinical trials. Its easy-to-use interface affords access to claims data from deidentified patient profiles representing over one-quarter of all employer-sponsored healthcare beneficiaries in the U.S., as well as tools to assess the impact of inclusion and exclusion criteria on eligible patient populations.   

“Currently, 80% of trials experience delays in recruiting and one out of four amendments is considered completely avoidable,” says Rob DiCicco, PharmD, deputy chief health officer for IBM Watson Health. “Breakdowns in the clinical trial process, including issues caused by study design decisions, may potentially delay access to life-changing therapies for patients. IBM Study Advance seeks to remove [those] barriers.”  

Study Advance’s collaborative workspace allows real-time collaboration among research team members who can manage and assign the team to specific sections of the protocol. The workspace also provides access to standard protocol templates and version control capabilities with complete traceability back to changes, reducing the average time required to author a clinical trial protocol. 

An advance demo of the tool indicates that it provides role-specific views for each project, including sections for study overview, trial summary, study design, study participants, statistical analysis, schedule of activities and interventions.