Previously submitted to: JMIR Medical Informatics (no longer under consideration since Jul 13, 2026)
Date Submitted: Jan 8, 2026
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Implementation of Individual Patient Data (IPD) Sharing Strategies in the VACCELERATE Project: A Case Study of COVID-19 Vaccine Trials
ABSTRACT
Background:
Sharing Individual Patient Data (IPD) from clinical trials is increasingly promoted to improve transparency, reproducibility, and scientific value. However, implementation remains challenging due to ethical, regulatory, and operational constraints, particularly in multinational studies.
Objective:
This study evaluates the implementation of IPD sharing strategies within three multinational COVID-19 vaccine trials (EU-COVAT-1 AGED, EU-COVAT-2 BOOSTAVAC, and EU-COVPT-1 CoVacc) conducted under the VACCELERATE platform, focusing on protocol integration, informed consent, anonymisation, and repository-based data governance.
Methods:
Data sharing strategies were prospectively integrated into all trial protocols. A harmonized informed consent template was developed to secure broad participant consent. Data collection followed Clinical Data Acquisition Standards Harmonization (CDASH) guidelines. A structured, risk-based anonymization methodology was applied to the IPD of the AGED trial, involving data minimization and transformation of quasi-identifiers. The anonymized IPD dataset and relevant trial metadata were prepared for deposition in the ECRIN Clinical Research Data Sharing Repository (crDSR), hosted within a secure trusted research environment, in a GDPR-compliant process.
Results:
All three trials included IPD sharing provisions in their protocols. Full implementation was achieved only in the EU-COVAT-1 AGED trial, which obtained ethics approval for the harmonised consent template and completed anonymisation and repository submission. Operational constraints and national regulatory differences prevented full implementation in the other trials. The EU-COVAT-1 AGED dataset was successfully deposited in the repository, enabling secure long-term preservation and controlled secondary access.
Conclusions:
The VACCELERATE experience demonstrates that responsible IPD sharing is feasible when integrated early into trial design and supported by harmonised consent, robust anonymisation, and secure repository infrastructure. Persistent regulatory heterogeneity and resource limitations remain key barriers. Early planning and institutional support are essential to making FAIR data sharing routine in multinational clinical research. Clinical Trial: EudraCT 2021-004526-29; https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-004526-29/DE/; 2021-004889-35; https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-004889-35; and 2021-004526-29; https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-004526-29
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