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ICAREdata™ Project

Integrating Clinical Trials and Real-World Endpoints


The overall goal of the ICAREdata™ project is to enable clinical oncology research by prospectively gathering high quality real-world data. The ICAREdata™ project is a collaboration between MITRE, the Alliance for Clinical Trials in Oncology, and the Dana-Farber Cancer Institute. The project is conducting a study in association with a randomized controlled trial (RCT), which aims to demonstrate the ability to calculate equivalent clinical trial endpoints using computable clinical treatment data. As part of the study, an open source infrastructure and data-capture methodology are being developed and piloted to capture higher quality EHR-based treatment data, and permit the assessment of 1:1 correlation between RCT and real-world data. The ICAREdata™ study will initially focus on disease progression and toxicity and will expand to cover a broader set of data across multiple clinical trials moving forward.


Support the collection of high quality real-world data (RWD) to
enable clinical oncology research

Increase data pool (RCT data + RWD)

Establishing large scale, prospective collection and integration of high quality clinical data across multiple clinical care sites to augment data collected from clinical trials.

Inform therapeutics development

Developing effective treatments for patients with rare tumors or uncommon disease types and understanding the natural history and response to therapy for diseases where multiple sequential therapeutic regimens are employed.

Inform regulatory decision-making

Helping to determine how to best use real-world evidence for medical product regulatory decision-making and achieving efficient and accurate post-market surveillance of FDA-approved therapeutics.

Inform data-driven patient care

Understanding efficacy and safety of approved therapeutic agents in underrepresented and minority populations and accumulating a large number of patients and data required to achieve success in personalized medicine.

Help cancer patients at the point of care

Address provider burden

Engineer a system for post market surveillance and observational studies

Demonstrate a repeatable approach that can be applied beyond cancer


Initially perform patient-level comparison of clinical trial and real-world data

Diagram demonstrating the ICAREdata™ project's approach, which will begin by comparing an individual's clinical trial data to their clinical treatment data. We can compare these endpoints and determine what significance can be gleamed from the similarities and differences in these two types of endpoints.