Data Interoperability in COVID-19 Vaccine Trials: Methodological Approach in the VACCELERATE Project
BackgroundData 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 effort...
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JMIR Publications
2025-03-01
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| Series: | JMIR Medical Informatics |
| Online Access: | https://medinform.jmir.org/2025/1/e65590 |
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| author | Salma Malik Zoi Pana Dorothea Christos D Argyropoulos Sophia Themistocleous Alan J Macken Olena Valdenmaiier Frank Scheckenbach Elena Bardach Andrea Pfeiffer Katherine Loens Jordi Cano Ochando Oliver A Cornely Jacques Demotes-Mainard Sergio Contrino Gerd Felder |
| author_facet | Salma Malik Zoi Pana Dorothea Christos D Argyropoulos Sophia Themistocleous Alan J Macken Olena Valdenmaiier Frank Scheckenbach Elena Bardach Andrea Pfeiffer Katherine Loens Jordi Cano Ochando Oliver A Cornely Jacques Demotes-Mainard Sergio Contrino Gerd Felder |
| author_sort | Salma Malik |
| collection | DOAJ |
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BackgroundData 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.
ObjectiveThe 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.
MethodsTo 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.
ResultsThe 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.
ConclusionsThis 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 RegistrationEudraCT 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 |
| format | Article |
| id | doaj-art-1501fdc7c1c246e9bf24c6cbe35323ef |
| institution | DOAJ |
| issn | 2291-9694 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | JMIR Publications |
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| series | JMIR Medical Informatics |
| spelling | doaj-art-1501fdc7c1c246e9bf24c6cbe35323ef2025-08-20T02:58:11ZengJMIR PublicationsJMIR Medical Informatics2291-96942025-03-0113e6559010.2196/65590Data Interoperability in COVID-19 Vaccine Trials: Methodological Approach in the VACCELERATE ProjectSalma Malikhttps://orcid.org/0009-0000-1965-1266Zoi Pana Dorotheahttps://orcid.org/0000-0002-5893-1081Christos D Argyropouloshttps://orcid.org/0000-0002-2090-2162Sophia Themistocleoushttps://orcid.org/0000-0003-3561-0004Alan J Mackenhttps://orcid.org/0000-0003-3320-8767Olena Valdenmaiierhttps://orcid.org/0000-0001-7882-2635Frank Scheckenbachhttps://orcid.org/0009-0003-7178-9854Elena Bardachhttps://orcid.org/0009-0005-5867-714XAndrea Pfeifferhttps://orcid.org/0009-0007-0481-6399Katherine Loenshttps://orcid.org/0009-0008-3009-2862Jordi Cano Ochandohttps://orcid.org/0000-0001-7037-1681Oliver A Cornelyhttps://orcid.org/0000-0001-9599-3137Jacques Demotes-Mainardhttps://orcid.org/0000-0002-0807-0746Sergio Contrinohttps://orcid.org/0000-0003-3409-5231Gerd Felderhttps://orcid.org/0009-0000-2540-0164 BackgroundData 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. ObjectiveThe 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. MethodsTo 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. ResultsThe 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. ConclusionsThis 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 RegistrationEudraCT 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:2021-004526-29https://medinform.jmir.org/2025/1/e65590 |
| spellingShingle | Salma Malik Zoi Pana Dorothea Christos D Argyropoulos Sophia Themistocleous Alan J Macken Olena Valdenmaiier Frank Scheckenbach Elena Bardach Andrea Pfeiffer Katherine Loens Jordi Cano Ochando Oliver A Cornely Jacques Demotes-Mainard Sergio Contrino Gerd Felder Data Interoperability in COVID-19 Vaccine Trials: Methodological Approach in the VACCELERATE Project JMIR Medical Informatics |
| title | Data Interoperability in COVID-19 Vaccine Trials: Methodological Approach in the VACCELERATE Project |
| title_full | Data Interoperability in COVID-19 Vaccine Trials: Methodological Approach in the VACCELERATE Project |
| title_fullStr | Data Interoperability in COVID-19 Vaccine Trials: Methodological Approach in the VACCELERATE Project |
| title_full_unstemmed | Data Interoperability in COVID-19 Vaccine Trials: Methodological Approach in the VACCELERATE Project |
| title_short | Data Interoperability in COVID-19 Vaccine Trials: Methodological Approach in the VACCELERATE Project |
| title_sort | data interoperability in covid 19 vaccine trials methodological approach in the vaccelerate project |
| url | https://medinform.jmir.org/2025/1/e65590 |
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