Sharing and re-using clinical trial data to maximise impact

Project Information

SHARE-CTD

Grant agreement ID: 101120360

DOI

10.3030/101120360

EC signature date 20 June 2023

Start date 1 January 2024

End date 31 December 2027

Funded under

• Marie Skłodowska-Curie Actions (MSCA)

Total cost

No data

EU contribution

€ 2 694 376,80

Coordinated by

LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN
Germany

Periodic Reporting for period 1 - SHARE-CTD (Sharing and re-using clinical trial data to maximise impact)

Reporting period: 2024-01-01 to 2025-12-31

Summary of the context and overall objectives of the project

Clinical trial data sharing is important for trustworthy and efficient health research. When trial data can be shared responsibly, study results can be checked independently, research questions can be revisited, and evidence can be reused for the benefit of patients and society. Clinical trial data sharing is crucial part of securing clinical trial integrity. At the same time, any sharing must respect privacy, consent, and legitimate confidentiality concerns. Sharing should contribute to create positive value for the society.
SHARE-CTD responds to this challenge by training doctoral researchers and developing practical solutions for the responsible access, sharing, and reuse of clinical trial data. By bringing together universities, hospitals, infrastructure providers, patient perspectives, regulators, academic research funders, and industry partners, the project aims to improve access to trial information, support timely communication of results, and strengthen high-quality data-sharing practice across Europe.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

SHARE-CTD moved from project set-up to active implementation. The consortium established the project's organisational structures (website, recruiting portal, project cloud), web presence on Linkedin), recruited and integrated doctoral researchers into local PhD programs, and launched a shared training and research environment across the partner institutions. Three schooling events (Propaedeutic; Reproducibility, Clinical Biostatistics and Clinical Trials; Meta-analysis, data protection, meta-research), professional training sessions (Presentation skills, Team building, Data Access and Communication between Stakeholders, Career Opportunities in Industry and Science), and a first datathon (Reproduce results from a Lancet Oncology paper) provided hands-on learning and helped build a common working culture across the network. The material created for the teaching and training events is publicly accessible via Zenodo. In parallel, the individual research projects were initiated and began to generate first outputs, including manuscripts (Journal of Clinical Epidemiology, Statistics in Medicine), preprints, practical guidance material, and conference contributions (World Conference on Research Integrity, ROeS and ISCB 2025, Responsible Research in Action Unconference). The project also started secondments with academic (University of Rennes, University of Zürich) and non-academic partners (Scicrunch, Deutsche Zentralbibliothek für Medizin, Bayer), giving doctoral researchers experience in different research and implementation settings. Overall, the established scientific, operational, and training foundations prepare the next phase of research delivery, wider dissemination, and impact. Details can be found on our website (share-ctd.eu).

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

SHARE-CTD goes beyond the current state of the art by treating clinical trial data sharing not only as a technical issue, but also as a scientific, organisational, ethical, and educational challenge. Current practice is often fragmented, difficult to navigate, and uneven across institutions and countries, which limits both transparency and reuse (thoroughly analysed in an upcoming scoping review). SHARE-CTD adds value by combining methodological research (relevant for shaping regulatory guidelines on the conduct of clinical trials analyses) with practical implementation tools (automatic screening of medical research papers regarding data sharing statements and their quality), collaborative re-use formats, and structured doctoral training. In this way, the project aims to move the field beyond general support for openness towards workable, quality-assured, and sustainable data-sharing approaches (FAIRification and data management). They can be used in everyday research practice and are meaningful for researchers, patients, and policy actors alike. Respective results are publicly available.