Advancing Oncology Research: EHR-To-EDC Success In A Complex, Adaptive Platform Trial

I-SPY 2, one of the longest-running adaptive platform trials in oncology, is revolutionizing breast cancer research through a dynamic, data-driven approach to evaluating novel therapies. Sponsored by Quantum Leap Healthcare Collaborative, the trial supports rapid, real-time testing of up to six investigational treatments simultaneously against a common control arm. Central to its success is OpenClinica’s advanced electronic data capture (EDC) and EHR-to-EDC integration, which together support the trial’s complex and evolving needs.

OpenClinica Core™ enables seamless form design, multi-randomization workflows, and adaptive arm management, while Insight™ provides real-time reporting and actionable dashboards across all trial sites. Participate™ enhances patient engagement for surveys and ePROs, improving data quality and operational efficiency. Most notably, Unite™ eliminates costly, error-prone manual data transcription by extracting structured and unstructured data directly from electronic health records. By automatically pulling patient medical records into the study database, OpenClinica helped accelerate the development of personalized breast cancer treatments.