JMIR Publications

ABSTRACT

Background:

Background Data standards are not only the key to making data processing efficient, but also fundamental to making the data itself interoperable. If the clinical trial data are structured according to international standards, data are much easier to analyse, and efforts needed for data cleaning, pre-processing and for secondary use are reduced. A common language and a common set of expectations facilitates interoperability between systems and/or devices.

Objective:

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

Methods:

To examine the degree of interoperability achieved in the project and to suggest methodological improvements. Interoperable points were identified based on the main core outcome areas (immunogenicity, safety, efficacy/clinical/physiological) that were focused on the development of the master protocol template and were manually compared for the (i) summary, objectives, and end points in the protocols of the three VACCELERATE clinical trials (EU-COVAT-1_AGED, EU-COVAT-2_BOOSTAVAC, EU-COVPT-1_CoVacc) and the master template protocols, (ii) Metadata of all three clinical trials and (iii) through a questionnaire survey evaluations of the differences in data management system and structures that allowed data exchange in the VACCELERATE network.

Results:

The non-commonality identified within the protocols and metadata were due to the differences in the populations, the variations in design of the protocols and the vaccination pattern. The detailed released metadata for all three vaccine trials was clearly designed using the internal standards, terminology, and general approach of CDASH (Clinical Data Acquisition Standards Harmonisation) (Data standards for data collection, e.g., on eCRFs). VACCELERATE received a very substantial boost simply from the selection of as the single data management provider Clinical Trials Centre Cologne (CTCC), with system database development coordinated by the same individual and without the need for coordination among different trial units which lead to a high degree of uniformity into the system automatically. Harmonised transfer of data to all sites with tried and trusted methods allowed a quick exchange and relatively secure method of transfer.

Conclusions:

This study illustrated that the use of master protocols can significantly increase the trial operation efficiency and the data interoperability if similar infrastructure and data management procedures are adopted and applied for multiple trials. To improve data interoperability and facilitate interpretation and analysis, shared data should be structured, described, formatted, and stored employing widely recognised data and metadata standards. Clinical Trial: EU-COVAT-1_AGED (EudraCT: 2021-004526-29 EU-COVAT-2_BOOSTAVAC (EudraCT: 2021-004889-35) EU-COVPT-1 COVACC (EudraCT: 2021-004526-29)