6557 Background: Clinico-genomic data sharing is consistently identified by the global oncology community as a critical requirement to accelerate the discovery and development of new targeted therapies. However, lack of effective collaborative models, fragmented and lengthy legal contracting processes, paucity of funding, and inadequate technological platforms have historically been obstacles for effective data sharing. Methods: In 2015, 10 US academic medical centers (AMC) and Foundation Medicine Inc. (FMI) formed PMEC. Feasibility assessments included creation of a master agreement across sites and willingness to use a central IRB. Oversight and research steering committees were created within the consortium. Through a centralized, secure web-based platform, FoundationInsight, we combined and shared de-identified, harmonized comprehensive FoundationOne genomic profiling data. Research proposals mining this data warehouse are invited quarterly from participant AMCs and peer-reviewed; approved studies are executed at all sites. Results: All 10 AMCs collaborated to execute a master registry participation agreement, followed by a master IRB protocol (New England IRB # 120180008), subsequently approved by individual site IRBs. Since its launch, the PMEC database has grown, on average, 60% per year, to now house over 14,000 cases. The shared dataset covers all tumor types (most commonly lung [17.2%], gastrointestinal [13.8%] and breast [9.2%]), encompasses genomic alterations in >300 genes, and reports relevant supplementary data such as tumor mutation burden and microsatellite instability status. To date, 15 studies have been proposed and evaluated using this platform, with 2 projects currently approved and in progress. Conclusions: We demonstrated the feasibility of creating a collaborative academic consortium that facilitates data sharing and potential discovery efforts in oncology. Technology solutions can accelerate the ability of AMCs, in partnership with central labs, to share and harmonize data to advance precision medicine. This approach lays the groundwork for conducting prospective, biomarker-enriched clinical trials among participating AMCs.
Read full abstract