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

By Cal Collins

The I-SPY 2 Trial, spearheaded by Quantum Leap Healthcare Collaborative (QLHC), represents a groundbreaking approach in oncology, specifically focused on newly diagnosed breast cancer patients through a randomized adaptive platform trial design. This innovative trial allows for the simultaneous evaluation of multiple treatments while maintaining continuous enrollment, thereby expediting the drug approval process. A key component of the trial's success is the integration of Electronic Health Records (EHR) with Electronic Data Capture (EDC) via OpenClinica's Unite platform.

This integration automates the collection of Electronic Case Report Forms (eCRFs) by sourcing data directly from EHRs, significantly reducing manual data entry and enhancing operational efficiency. The trial exemplifies real-time data reporting and advancements in personalized medicine, underscoring the critical role of capturing data at the point of care to improve patient outcomes. OpenClinica's solutions are pivotal in supporting the trial's innovative methodologies and operational excellence. A detailed case study is available for further insights into the trial's achievements.