At OpenClinica, we are especially proud of the work we are doing with the I-SPY 2 Trial, sponsored and operated by Quantum Leap Healthcare Collaborative (QLHC). It’s an interventional, randomized adaptive platform trial for newly diagnosed breast cancer patients, and was one of the first and is now one of the longest-running platform trials ever.
It’s also a rather complex, adaptive platform trial.
I-SPY 2 uses an adaptive master protocol that provides a regulatory framework to study multiple treatments in the same study – up to six agents or combinations of agents in parallel against a common control arm. It also allows new agents to enter and leave the study without having to halt enrollment or resubmit the entire clinical trial protocol for regulatory review, avoiding lengthy delays in getting much-needed treatments to the patients who need them.
EHR-to-EDC Success in Oncology Clinical Trials
At the heart of the success of I-SPY 2 Trial is EHR-to-EDC integration.
OpenClinica specializes in enabling EHR-to-EDC eSource integration through a rapid, cookie-cutter standardized implementation model, leveraging a technology approach based on industry standards, rigorous quality and compliance. OpenClinica Unite facilitates the completion of Electronic Case Report Forms (eCRFs) through automated, direct capture from Electronic Health Record (EHR) systems. Launched by the end-user within a participant’s EHR patient chart, Unite populates eCRFs by automatically extracting source data directly from the EHR and applying it to the eCRF, without need of manual transcription or abstraction.
Given the complexity and the importance of this research, we are gratified by the clinical trial’s success.
In the words of Laura J. Esserman, MD, MBA, Alfred A. de Lorimier Endowed Chair in General Surgery, professor, Departments of Surgery and Radiology, affiliate faculty, Institute for Health Policy Studies, University of California San Francisco (UCSF); director, UCSF Breast Care Center; co-leader, Breast Oncology Program, Helen Diller Family Comprehensive Cancer Center:
We have long needed to focus on the capture of mission critical data at the point of care. Unite enables us to learn from every patient we see, fueling the cycle of knowledge and innovation. We need these same tools to match patients to resources (including clinical trials) that will improve their care experience and their outcomes. Unite is a building block for 21st century personalized trials that provide clinicians with data and confidence to adopt new standards of care.”
Adam Asare, Chief Data Officer, QuantumLeap Healthcare Collaborative, emphasized:
The I-SPY 2 breast cancer trial is an extraordinarily complex trial on the leading edge of clinical science. OpenClinica has provided us with a robust set of solutions that work to meet the needs of our growing, adaptive platform trial, helping us to advance the availability of personalized medical care for breast cancer patients.”
EHR-to-EDC integration is working.
The I-SPY2 statistics are, as of September 2024, are:
- Participants: 4,906
- Amendments: 37
- Agents Evaluated: 25
- Agents Receiving Accelerated Approval: 3
- Forms automated: 95,456
- Data values automated: 20 million+
Additional results include:
- Operational excellence for dynamic study arms
- Engagement with patient-reported outcomes
- Real-time reporting and insights
- Efficiency gains across trials
- Advancing personalized medicine
To read more about the results and how we achieved them, download the case study by clicking here.