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. 2025 Mar 7:13:e65590.
doi: 10.2196/65590.

Data Interoperability in COVID-19 Vaccine Trials: Methodological Approach in the VACCELERATE Project

Salma Malik #  1 , Zoi Pana Dorothea #  2 , Christos D Argyropoulos #  3 , Sophia Themistocleous #  2 , Alan J Macken #  4 , Olena Valdenmaiier #  5 , Frank Scheckenbach #  6 , Elena Bardach #  6 , Andrea Pfeiffer #  6 , Katherine Loens #  7 , Jordi Cano Ochando #  8 , Oliver A Cornely #  9 , Jacques Demotes-Mainard #  1 , Sergio Contrino #  1 , Gerd Felder #  1
Affiliations

Data Interoperability in COVID-19 Vaccine Trials: Methodological Approach in the VACCELERATE Project

Salma Malik et al. JMIR Med Inform. .

Abstract

Background: Data standards are not only key to making data processing efficient but also fundamental to ensuring data interoperability. When clinical trial data are structured according to international standards, they become significantly easier to analyze, reducing the efforts required for data cleaning, preprocessing, and secondary use. A common language and a shared set of expectations facilitate interoperability between systems and devices.

Objective: The main objectives of this study were to identify commonalities and differences in clinical trial metadata, protocols, and data collection systems/items within the VACCELERATE project.

Methods: To assess the degree of interoperability achieved in the project and suggest methodological improvements, interoperable points were identified based on the core outcome areas-immunogenicity, safety, and efficacy (clinical/physiological). These points were emphasized in the development of the master protocol template and were manually compared in the following ways: (1) summaries, objectives, and end points in the protocols of 3 VACCELERATE clinical trials (EU-COVAT-1_AGED, EU-COVAT-2_BOOSTAVAC, and EU-COVPT-1_CoVacc) against the master protocol template; (2) metadata of all 3 clinical trials; and (3) evaluations from a questionnaire survey regarding differences in data management systems and structures that enabled data exchange within the VACCELERATE network.

Results: The noncommonalities identified in the protocols and metadata were attributed to differences in populations, variations in protocol design, and vaccination patterns. The detailed metadata released for all 3 vaccine trials were clearly structured using internal standards, terminology, and the general approach of Clinical Data Acquisition Standards Harmonisation (CDASH) for data collection (eg, on electronic case report forms). VACCELERATE benefited significantly from the selection of the Clinical Trials Centre Cologne as the sole data management provider. With system database development coordinated by a single individual and no need for coordination among different trial units, a high degree of uniformity was achieved automatically. The harmonized transfer of data to all sites, using well-established methods, enabled quick exchanges and provided a relatively secure means of data transfer.

Conclusions: This study demonstrated that using master protocols can significantly enhance trial operational efficiency and data interoperability, provided that similar infrastructure and data management procedures are adopted across multiple trials. To further improve data interoperability and facilitate interpretation and analysis, shared data should be structured, described, formatted, and stored using widely recognized data and metadata standards.

Trial registration: 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.

Keywords: adult; clinical trials; data management; harmonization; interoperability; metadata; pediatric; protocol; standards; systems.

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Conflict of interest statement

Conflicts of Interest: OAC reports grants or contracts from iMi, iHi, DFG, BMBF, Cidara, DZIF, EU-DG RTD, F2G, Gilead, MedPace, MSD, Mundipharma, Octapharma, Pfizer, Scynexis; consulting fees from Abbvie, AiCuris, Basilea, Biocon, Boston Strategic Partners, Cidara, Elion Therapeutics, Gilead, GSK, IQVIA, Janssen, Matinas, MedPace, Menarini, Melinta, Molecular Partners, MSG-ERC, Mundipharma, Noxxon, Octapharma, Pardes, Partner Therapeutics, Pfizer, PSI, Scynexis, Seres, Seqirus, Shionogi, The Prime Meridian Group; speaker and lecture honoraria from Abbott, Abbvie, Akademie für Infektionsmedizin, Al-Jazeera Pharmaceuticals/Hikma, amedes, AstraZeneca, Deutscher Ärzteverlag, Gilead, GSK, Grupo Biotoscana/United Medical/Knight, Ipsen Pharma, Medscape/WebMD, MedUpdate, MSD, Moderna, Mundipharma, Noscendo, Paul-Martini-Stiftung, Pfizer, Sandoz, Seqirus, Shionogi, streamedup!, Touch Independent, Vitis; payment for expert testimony Cidara; and participation on a DRC, DSMB, DMC, Advisory Board for AstraZeneca, Cidara, IQVIA, Janssen, MedPace, Melinta, PSI, Pulmocide, Vedanta Biosciences. All other authors report no conflicting interests.

Figures

Figure 1
Figure 1
Methodology for the identification of the interoperable data points. CTCC: Clinical Trials Centre Cologne; UCD: University College Dublin.
Figure 2
Figure 2
Interoperability between the 3 specific clinical trial protocols (summary).
Figure 3
Figure 3
Noncommonality parameters identified in the VACCELERATE projects (protocols, metadata and data management, and systems). EDC: Electronic Data Capture; EDTA: ethylenediaminetetraacetic acid; LiHep: lithium heparin; PBMC: peripheral blood mononuclear cell; PE: physical examination; UCD: University College Dublin; WB: whole blood.
Figure 4
Figure 4
COS interoperability between the vaccine trial and master protocols.
Figure 5
Figure 5
Metadata interoperability based on COS. EDTA: ethylenediaminetetraacetic acid; LiHep: lithium heparin; MedDRA: Medical Dictionary for Regulatory Activities; PBMC: peripheral blood mononuclear cell; PD: protocol deviation; PE: physical examination; VS: vital sign; WB: whole blood.
Figure 6
Figure 6
Interoperability between the data management and systems. CDASH: Clinical Data Acquisition Standards Harmonization; CTCC: Clinical Trials Centre Cologne; DM: data management; eCRF: electronic case report form; EDC: Electronic Data Capture; FAIR: Findable, Accessible, Interoperable, and Reusable; SOP: standard operating procedure.
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