Overview
Pragmatic clinical studies support faster enrollment of diverse patient populations by integrating research into routine care and enabling studies to be conducted in community practice settings. This multicenter, prospective, observational biospecimen collection study, activated within a technology-enabled network of sites, incorporates pragmatic design elements. The study will enroll participants diagnosed with early stage cancers in select solid tumors with planned curative-intent surgery.
Approximately 1,350 pts will be enrolled, mainly across Flatiron Research Network community oncology sites in which study visits will correspond with routine care. Research tissue and blood samples are obtained upon enrollment and at study-specified intervals up to 5.5 years or until disease recurrence for analysis by Exact Sciences laboratories. This study’s tech enablement features an AI-assisted patient ascertainment and integrated electronic health record-to-electronic data capture system data transfer.
Why this matters
This research demonstrates how technology and pragmatic study design can make cancer research more efficient, inclusive, and relevant to real-world patients. By embedding research into routine community care and using AI to identify eligible patients, the study accelerates enrollment and reduces the burden on clinical sites. The study’s design and technology-driven methods could serve as a model for future research, helping to bring the benefits of precision medicine to more patients, faster.