As we wrote in our new case study,
The I-SPY series of trials are reshaping the future of personalized oncology trials, helping make available new, better and more personalized treatments, faster.”
QuantumLeap Healthcare Collaborative’s I-SPY 2 is a complex, adaptive oncology clinical trial. Exclusively for newly diagnosed breast cancer patients, the I-SPY 2 trial uses an interventional, randomized adaptive platform trial to increase trial efficiency by minimizing the number of participants and time required to evaluate an experimental agent.
OpenClinica solutions for personalized oncology trials
The I-SPY 2 approach is working, as detailed in the case study.
As of September 2024, the I-SPY 2 trial numbers are:
- Participants: 4,906
- Amendments: 37
- Agents Evaluated: 25
- Agents Receiving Accelerated Approval: 3
- Forms automated: 95,456
- Data values automated: 20 million+
To achieve this level of success, the I-SPY 2 trial relies on a combination of OpenClinica solutions:
- Data migration services to move the I-SPY 2 trial from its previous system to the OpenClinica platform,
- OpenClinica Core electronic data capture (EDC) platform, along with Insight for its reporting and dashboards,
- OpenClinica Participate for electronic patient reported outcomes (ePRO),
- OpenClinica’s EHR eSource solution, Unite™, to establish a flexible framework for integration and completion of Electronic Case Report Forms (eCRFs) through automated, direct capture from Electronic Health Record (EHR) systems.
At OpenClinica, we are heartened that our solutions and services are used in such important work as developing new treatments for breast cancer, a disease that afflicts one in eight American women and is the leading cause of cancer death in females worldwide.
Explore the full case study to see how I-SPY 2 is redefining oncology research — and how OpenClinica supports personalized oncology trials. Download the case here!