BY-COVID D5.2 Secondary use of vaccine trial data and biosamples

The scope of D5.2 Secondary use of vaccine trial data is to describe the actions taken within the BY-COVID project to improve clinical trial data sharing and secondary use in a pandemic context, utilising COVID-19 trials as a use case. Secondary use of clinical trial data allows independent researchers to validate findings, test new hypotheses without additional patient interventions, and improve trial designs and methods. It supports regulatory safety studies, facilitates research collaborations like meta-analyses, and helps develop new healthcare technologies, such as AI-based algorithms. Since the adoption of the FAIR principles in 2016, key organisations have promoted data sharing to enhance research transparency, validity, and maximise the return on research investment.

Despite this “call for action” from major stakeholders, clinical trial data sharing remains low. Indeed, implementing data sharing in a clinical trial requires several steps at different stages of the clinical trial lifecycle (pre-trial, during trial set-up, at the end of the trial, at the data sharing stage). The European Clinical Research Infrastructure Network (ECRIN) and the University of Oslo (UiO) developed the clinical research Data Sharing Repository (crDSR, https://crdsr.ecrin.org/) to provide a secure, ethically, and legally compliant platform for sharing clinical research data based in the EU. 

The crDSR is currently being piloted for the data sharing of the VACCELERATE-funded trial EU-COVAT-1 AGED. EU-COVAT-1 AGED is a multinational, phase 2 trial assessing the immunogenicity and reactogenicity of different COVID-19 vaccines in older adults. Despite several data sharing steps being already implemented (e.g., inclusion of data sharing section in the clinical trial protocol, developing a dedicated Patient Information Sheet and Informed Consent Form for secondary use, utilisation of interoperability standards developed by the Clinical Data Interchange Standards Consortium (CDISC, https://www.cdisc.org/), initiation of the Data Transfer Process within the crDSR, negotiation of a Data Transfer Agreement with the crDSR) the trial faced significant delays that have pushed the timeline for completion of all data sharing steps to December 2024. The delays were mainly due to the evolving public health policies across Europe, such as for example the recommendation for a third vaccination dose to higher risk groups or the orientation towards variant-specific vaccines that impacted the trial conduct (several amendments of the trial protocol necessary) and recruitment. 

In search of alternative use cases, COVID-19 studies were identified for potential data sharing via the crDSR, using the ECRIN MetaData Repository (crMDR, https://crmdr.ecrin.org/). Out of 7,618 COVID-19 registered studies, 1,261 (16.55%) indicated willingness to share data. The BY-COVID team developed a classification system to evaluate the Data Sharing Statements (DSS) and applied it to a sample of 200 studies providing a BY-COVID inventory of selected studies categorised by the likelihood to share data. From this inventory 131 studies that were categorised as highly likely to share data but had not employed a designated repository were contacted with a follow-up survey to 5 clarify their data sharing conditions and eventually provide additional piloting exercises for crDSR. Around 75% of the respondents remained open to data sharing, with 25% answering “Yes” to an eventual collaboration with the crDSR for making their Individual Participant Data (IPD) available for secondary use.