JMIR Publications

ABSTRACT

Background:

Rapid research responses to emerging infectious disease (EID) outbreaks depend not only on how quickly studies are launched, but also on whether their data can be combined, compared, and reused across studies. Health data standards, including shared vocabularies, terminology, and information models, are the structural prerequisite for interoperable, findable, accessible, interoperable, and reusable (FAIR) data. Despite European Commission (EC) investments exceeding €130 million across the EID cohort and clinical trial consortia coordinated through the Cohort Coordination Board (CCB) and Trial Coordination Board (TCB), little empirical evidence exists on the extent to which these consortia adopt standards, the barriers they face, or what funders could do to improve implementation.

Objective:

To characterise health data standards adoption across EC-funded EID consortia, identify the barriers that prevent uptake, and generate evidence-based recommendations for funders to strengthen standards implementation for the rapid reuse of interoperable participant-level data in epidemic detection and response.

Methods:

We conducted a cross-sectional online survey May 2023-Feb 2024, developed through a literature review and stakeholder consultation, with CCB and TCB-affiliated EC-funded EID consortia. Research networks and consortia outside these boards could participate if forwarded the survey. We collected information on consortium characteristics, standards use, barriers to adoption, awareness of EC-supported standardisation initiatives, and recommendations for improving uptake. Responses were analysed descriptively; open-text responses were categorised thematically.

Results:

Thirty-three responses, representing 15 consortia or research networks spanning over 40 countries were collected. Most responses came from cohort consortia. Adoption of data standards was limited. The most frequently used standards were ICD codes (n=10) and the Systematised Nomenclature of Medicine Clinical Terms (n=9); 7 respondents reported not using standards. The main barriers were insufficient experience applying standards (n=17), lack of budget (n=12), uncertainty about which standard to use (n=12), uncertainty about which standards related studies used (n=9), and inadequate tools (n=9). Awareness of EC initiatives designed to support standards adoption was strikingly low, suggesting that EC investment in standards support is not reaching its intended audience. Respondents recommended dedicated budgets, clearer guidance on preferred standards by data type, better communication of the benefits of standards adoption, stronger tooling, and funder mandates.

Conclusions:

Health data standards are underused across European EID consortia, representing a preventable bottleneck for pandemic preparedness despite substantial public investment. European funders can address this through the following actions recommended by major EC-funded EID Consortia: mandating dedicated standards budgets at the grant submission stage, issuing formal guidance on preferred standards by data type, investing in open-source tooling that delivers value to data generators, requiring machine-actionable data management plans, and establishing a public registry of standards adopted by funded consortia. Strengthening coordinated standards adoption is a necessary and achievable step toward the FAIR, interoperable research data infrastructure that effective pandemic response demands. Clinical Trial: Not applicable.