The Cancer Research Data Exchange Summit occurred at the National Cancer Institute (Shady Grove, MD) on 8-9 May 2024. The organizers of this meeting were centers within the US Health and Human Services (HHS): NIH/NCI, CMS, FDA, CDC, and FDA.
The Scope of Activities for this Summit, provided essentially as goals in advance were as follows:
- Summarize Opportunities and Challenges: Identify opportunities, and challenges related to data collection, interoperability, and standards for advancing cancer research through data exchange
- Align on Key Data Concepts: Clarify data needs related to cancer data for USCDI+ Cancer use cases
- Leverage Data Standards and Methods: Consider existing data standards (such as FHIR, HL7, etc.) for cancer data and best practices for data collection and extraction methods
- Ensure Alignment on Future State: Refine the desired future state for cancer data exchange, understand gaps between the current state and the desired future state and review approaches to filling them
- Refine Data Collection and Exchange: Prioritize data elements based on their impact and feasibility
- Explore Barriers and Enablers: Capture possible short and long term actions to address barriers to data collection and exchange
- Develop a List of Existing Technologies: Identify technologies or requirements that address current barriers and enablers, considering both short-term and long-term solutions
Opening remarks on 8 May were made by the president of DiMe, representing CancerX (https://cancerx.health/about-cancerx/) and an ONC representative. The introductory panel “Stories from the Field” was presented from federal and industry perspectives by representatives from ONC, NCI, CMMI/EOM, CodeX, Vulcan, and Duke.
Three use cases were then introduced to the audience: a) Clinical Trials Matching; b) Immune-related Adverse Events; c) Cancer Registries
The initial breakout groups for 8 May were organized by role, specifically: Data Generators; Clinical Care Teams; Specialty Groups that Inform Care; Middleware & Data Vendors; Standards & Semantic Experts; Specialty Groups that inform Data Exchange and Sharing; Patients, Caregivers & Advocates; Researchers & Data Scientists RWD; Regulators/Policy Governance, Payers & Public Health with RWD; Senior Executives from the RWD Ecosystem. Each group discussed opportunities and challenges related to data collection, interoperability and standards for cancer research and then provided a read-out of their discussions around Cancer Research Data Exchange to the others. Interestingly, there was significant overlap on the barriers and opportunities with several mentioning leveraging standards already in place as an opportunity.
On 9 May the three use case groups (a-c above) met to discuss Current and Future State, Data Elements, Timelines, and Actions.
As background for the meeting, the ONC provided information about an Enhancing Oncology Model (EOM):
USCDI+ Cancer has aligned with the Centers for Medicare & Medicaid (CMS) Enhancing Oncology Model (EOM). The EOM aims to drive transformation and improve care coordination in oncology care by preserving and enhancing the quality of care furnished to beneficiaries undergoing treatment for cancer while reducing program spending under Medicare fee-for-service.” The idea is that, since these data elements will be tied to reimbursement, they will be in the electronic health record and thus available for oncology clinical research.
USCDI+ Cancer Enhancing Oncology Model Data Elements
Additional related resources/references for data elements and standards, cited during the meeting, include the following:
- HL7 CodeX Accelerator’s (https://codex.hl7.org/) mCODE (minimal Common Oncology Data Elements)
- CDISC SDTM and the Oncology Therapeutic Area User Guides (cdisc.org/standards/)
- NCI caDSR (Metadata Services for Cancer Research | CBIIT) and NCI Enterprise Vocabulary Services, which maintains CDISC and FDA Terminology (https://evs.nci.nih.gov/about-evs)
- IHE RFD and the ASTER study (Linder, Jeffrey A et al, pharmacoepidemiology and drug safety 2010; 19: 1211–1215, Published online 11 October 2010 in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/pds.2027)
- Vulcan Accelerator’s FHIR IG for Adverse Events (https://build.fhir.org/ig/HL7/fhir-ae-care-ig/)
- xShare IPS+R (https://xshare-project.eu/)
- College of American Pathologists (CAP) (e.g. Cancer Protocol Templates (https://www.cap.org/protocols-and-guidelines/cancer-reporting-tools/cancer-protocol-templates)
- NAACCER (North American Association of Central Cancer Registries) https://www.naaccr.org/
- CancerLinQ (which has now been acquired by Concert AI): Experiences with non-standard data and inclusion/exclusion [e.g. Pitfalls with analyses of real-world data: A look at ASCO’s CancerLinQ Discovery Multiple Myeloma dataset. | Journal of Clinical Oncology (ascopubs.org) and (https://d32wbias3z7pxg.cloudfront.net/meeting/299/abstract/pdf/299-15082-224889.pdf)]
The goal of mentioning these standards was to encourage the use of what is already available, the need to harmonize across certain of these standards and models and to deter the development of new standards or elements without verifying the existence of an existing standard.
CDISC, ONC, and FDA representatives had a meeting on the afternoon of 9 May to discuss how USCDI+ in FHIR could be leveraged, along with CDISC standards and terminology (maintained by NCI EVS) to support research and to provide FDA with data in formats that support their work. A figure to depict this opportunity is being developed. xShare was mentioned, particularly in terms of striving for a global standard core set of data elements from healthcare that can be used for research and public health.
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Written by Rebecca D. Kush, PhD, Founder and President Emeritus, CDISC; President, Catalysis.
Contact the author at rkush@catalysisresearch.com.
