The CRI and Elligo Health Research are collaborating on a new FDA data harmonization project.

The CRI is undertaking a new collaborative project with Elligo Health Research in which both teams will assist the US Food and Drug Administration (FDA) with developing a standard common data model to guide evidence generation in biomedical research studies and bridge clinical research and clinical care.

As part of a grant awarded by the Patient Centered Outcomes Research (PCOR) Trust Fund, the FDA is currently involved in an effort to harmonize multiple common data models and open standards. By mapping data from disparate sources to one consensus-based model, the project will facilitate interoperability between data networks and make new research possible.

The CRI and Elligo will work together toward this end on an initial Use Case, which will focus on safety data from cancer patients treated with immunotherapy. Immunotherapy drugs are transforming cancer treatment, with the FDA having recently approved such drugs for a variety of cancers. In order to better understand the safety of these treatments, the FDA would like to study “real world” safety data from patients alongside the data generated in clinical trials.

The FDA awarded a grant to Elligo to pursue this Use Case study, and Elligo engaged the CRI to bring the project to fruition. Due to our unique combination of talent, resources, and infrastructure, we are exceptionally well positioned to contribute valuable data and insight to this study. Under the direction of Samuel Volchenboum, MD, PhD, the CRI has emerged as a leader in establishing clinical data commons, with ongoing projects including commons for neuroblastoma (INRG), rhabdomyosarcoma (INSTRuCT), and multiple pediatric cancers and structural birth defects (Gabriella Miller Kids First DRC).

Our Clinical Research Data Warehouse is a repository of world-class depth and quality, for which our team brings together and harmonizes data from disparate sources to create a curated source of clean, research-ready information. Our team also has specific expertise in the development and maintenance of data models, including experience mapping source-level data to common data model types. This experience makes us a natural partner for Elligo in developing and implementing interoperability standards.

Leveraging architecture already developed by the PCOR Trust Fund project, the CRI will work with the FDA and Elligo through a process of cohort discovery; data curation, extraction, and analysis; and eventual mapping and review of de-identified patient-level data. Alongside our technical expertise, clinical data, and secure infrastructure, the CRI team will contribute regulatory support, data de-identification, and project coordination.

In addition to providing the FDA with valuable information about the safety of new cancer treatments, this project will help assess the value of the standard common data model for real world evidence research, as well as the tools and methods used to achieve the data harmonization. We are proud to be taking part in this important government research project.