eTRANSAFE: Building a sustainable framework to share reproducible drug safety knowledge with the public domain

Johan van der Lei, Sirarat Sarntivijai*, Niklas Blomberg, Katharina B. Lauer, Katharine Briggs, Thomas Steger-Hartmann, John-Michael Sauer, Richard Liwski, Miranda Mourby, L Camprubi

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Integrative drug safety research in translational health informatics has rapidly evolved and included data that are drawn in from many resources, combining diverse data that are either reused from (curated) repositories, or newly generated at source. Each resource is mandated by different sets of metadata rules that are imposed on the incoming data. Combination of the data cannot be readily achieved without interference of data stewardship and the top-down policy guidelines that supervise and inform the process for data combination
to aid meaningful interpretation and analysis of such data.
The eTRANSAFE Consortium's effort to drive integrative drug safety
research at a large scale hereby present the lessons learnt and the
proposal of solution at the guidelines in practice at this Innovative
Medicines Initiative (IMI) project. Recommendations in these
guidelines were compiled from feedback received from key
stakeholders in regulatory agencies, EFPIA companies, and academic
partners. The research reproducibility guidelines presented in this
study lay the foundation for a comprehensive data sharing and
knowledge management plans accounting for research data
management in the drug safety space - FAIR data sharing guidelines,
and the model verification guidelines as generic deliverables that best
practices that can be reused by other scientific community members at large.
FAIR data sharing is a dynamic landscape that rapidly evolves with
fast-paced technology advancements. The research reproducibility in
drug safety guidelines introduced in this study provides a reusable
framework that can be adopted by other research communities that
aim to integrate public and private data in biomedical research space
Original languageEnglish
Article number287
Number of pages13
Publication statusPublished - 7 Mar 2022

Bibliographical note

Grant information:
This research received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreements eTRANSAFE (777365). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA companies in kind contribution.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

© 2022 Sarntivijai S et al. T


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