Perspectives
The Data Summit will bring together scientific and technical communities to assess existing data standards, identify strengths, weaknesses, and gaps, and determine the necessary data requirements to implement the USCDI+ Cancer Moonshot Use Cases. Below is a description of the intended perspectives we seek to include in the Data Summit.
Category I: Data Entry, Local Integration, & ETLs
Group I: Data Generators
Groups or individuals whose primary business/role is data generation at the point of care.
EXAMPLE MEMBERS: EMR vendors, Lab vendors, Imaging, Genomic/Diagnostic test data generators, etc.; Registry staff; ONC, CMS/EOM, CDC
Group II: Clinical Care Teams
Individuals or groups caring for the patients who deserve better quality data at the point of care - including clinical decision support tools to help summarize evidence & personalized treatment decision-making.
EXAMPLE MEMBERS: Physicians, Nurses, Patient Navigation (e.g., Thyme Care)
Group III: Specialty Groups that Inform Care
Groups or individuals whose primary role is to sponsor, summarize evidence, and provide input on care guidelines.
EXAMPLE MEMBERS: NCCN, ASCO, AACR
Category II: Extraction, Transformation, and Harmonization
Group IV: Middleware & Data Vendors
Groups who play a key role in data extraction, harmonization, linking/ aggregating, and/or housing RWD.
EXAMPLE MEMBERS: Data Aggregators/Vendors (e.g., Flatiron, Tempus, etc.), “Switches”, Research Product/support: IgniteData, LindAI
Group V: Standards & Semantic Experts
Individuals or Groups who are leading RWD data semantics & standards.
EXAMPLE MEMBERS: NIH/NCI; NLM; NAACCR
Group VI: Specialty Groups that inform Data Exchange & Sharing
Groups whose main role is influencing interoperability: organization, harmonization & sharing.
EXAMPLE MEMBERS: CancerX, Vulcan, AMIA, MITRE, etc. Federal: ONC, NIH/NCI, FDA, CMS
Category III: Entire Data Journey
Group VII: Patients, Caregivers, & Advocates
Patients and the people caring for them. All who are working to personalize treatment. This group needs easier, more transparent ways to access, combine, share, and provide input into their clinical data. This includes awareness and control over how their data is used in research.
EXAMPLE MEMBERS: Patients, Caregivers, Patient networks (eg, PPRN)
Group VIII: Researchers & Data Scientists RWD
Individuals and Groups (Individual, Academic, Private/Corporate, etc.) who require higher quality data to engage in the research that provides evidence on disease, treatment & outcomes- including safety, efficacy, and effectiveness of treatments.
EXAMPLE MEMBERS: Academic Investigators, Cooperative Group members, Sponsors, OMOP, ISPE/ISPOR/DIA, Transcelerate; Flatiron, Cancerlinq, Tempus, IgniteData, LindAI, FDA, CMS, NIH/NCI, PCORI, ARPA-H, CDC
Group IX: Regulators/Policy/Governance, Payers & Public Health with RWD
Groups invested in high-quality data to ens ure optimal safety, efficacy, and effectiveness of treatments. Groups who need adequate granularity, provenance, and transparency into the data & the systems involved in collection, de-identification, harmonization & exchange.
EXAMPLE MEMBERS: Sponsors/Biopharma, Drug & Diagnostic Developers; Registries. FoCR, Reagan-Udall Foundation, Duke-Margolis, FNIH; FDA, CMS, NIH/NCI, CDC
Group X: Senior Executives
Executives from the RWD ecosystem who have tenure and experience with developing and implementing technology solutions within clinical care and research settings. Individuals who can provide succinct perspectives on the barriers and requirements to ensure USCDI+ Cancer use case success.