Dr. Lina Pugliano, BIG and BrEAST Research Fellow, July 2012
Sharing and integration of data from oncology clinical trials
At the centre of INTEGRATE is a shared repository of clinical, genomic and imaging data, originating from multiple clinical trials in breast cancer. By accessing data from multiple trials, researchers will be able to build predictive models, identify biomarkers and answer other research questions faster and with more confidence. Additionally, fine-grained control of access to subsets of the data by different user groups will enable flexible patterns of collaboration.
The “semantic interoperability layer”, consisting of the core data set and flexible data and metadata models, will allow the easy integration of data and the implementation of intelligent workflows that incorporate knowledge of breast cancer. By adopting commonly agreed standards for data sharing and medical nomenclature, INTEGRATE will also be able to “talk” to other data sharing platforms and become a data hub integrated in a wider network.
Support for patient screening in oncology clinical trials
INTEGRATE will provide tools to streamline the screening phase of breast cancer clinical trials. Before a patient is enrolled in a clinical trial, she (or he) must meet a certain number of eligibility criteria such as age, cancer type and stage, or previous or concomitant treatments. INTEGRATE will facilitate this by managing lists of eligibility criteria for registered trials, and by automating electronic data capture and the evaluation of the criteria. It will also provide interfaces to allow linking and extracting of clinical data for eligibility from electronic health records, the acquisition of molecular testing data from central laboratories, and the tracking of biological samples.
INTEGRATE will also provide tools for central review of data across trials, allowing the definition of panels of experts and creating a framework for accessing and annotating data. In this context, it will integrate tools to visualize and annotate digital pathology images.
Finally, tools for statistical and bioinformatics analyses of data will also be incorporated in INTEGRATE, and a collaborative environment will be provided where researchers can share and annotate statistical models built from the data. The modular nature of the architecture will make it possible to easily plug in analytical components on top of the data querying component.
Tools for researchers
The loose coupling between these components through a standards-based, service-oriented architecture will create a platform that can be readily adapted to changing requirements and integrate external components. This approach also ensures that parts of INTEGRATE can be reused in other contexts.
Impact & Dissemination
INTEGRATE is being developed and will be used in the context of the Breast International Group (BIG) research program to support molecular screening and data sharing for its users. Parallel to this, INTEGRATE is also reaching out other ICT initiatives (EURECA, p-medicine, TRANSCEND, Sage Bionetworks, VPH NOE etc.) and end-users groups through meetings, participation in events and through the upcoming INTEGRATE Launching Event (September 2013)