NEWS

The French government is addressing the issue of clinical trial transparency

2025.05.20

Two French ministries (Research and Health) have signed recently an important new policy document: https://www.enseignementsup-recherche.gouv.fr/sites/default/files/2025-05/clinical-trials-report---en-36812.pdf . This initiative is part of the broader national strategy on open science: https://www.ouvrirlascience.fr/national-plan-for-open-science-4th-july-2018/. The report focuses on results posting, not data sharing per se, but the topics are closely related and highly relevant to our work. Notably, one of the key recommendations (1.10) is: "Continue the work on improving clinical trial transparency by creating a working group on clinical trials data sharing. On several occasions, the Working Group has discussed the need to put forward proposals of guidelines for data and documentation sharing in clinical trials. Given the complexity of the task, the group suggests initiating a new, dedicated project once this group’s recommendations on trial results posting have been published."


Revision of the SPIRIT and CONSORT guidelines

2025.05.20

SHARE-CTD welcomes the important 2025 revision of the SPIRIT and CONSORT guidelines: https://www.consort-spirit.org/. Both helpauthors to design and report their trials completely and transparently. The 2025 versions provides a new section on open science addressing issues of accessibility of trial protocol and statistical analysis plan (Item 5) and data sharing (Item 6). The new item lay the foundation for a FAIR sharing of clinical trial data (SHARE-CTD): Where and how the individual de-identified participant data (including data dictionary), statistical code, and any other materials will be accessible. This is an important opportunity to raise awareness that evidence created from this data can be used by regulatory bodies, health technology assessment agencies, and clinical medicine to the provide more profit to patients.


LORIER Webinar Series on Reproducibility and Meta-Research

2025.05.06

LORIER launches a series of webinars on reproducibility and meta-research The LORIER Ambassadors Program for Reproducibility and Meta-Research kicks off a series of monthly webinars dedicated to the challenges of reproducible health research. Organized in partnership with OSIRIS, SHARE-CTD, Restores, and the French Network for Reproducible Research, this series will feature international speakers and a variety of topics: sharing clinical data, tools for reproducibility, ambassador networks, and FAIRification of data. The dates and agenda are published via https://restores.univ-rennes.fr/highlights/lorier-webinar-series-reproducibility-and-meta-research.


Second schooling event in October 2025 in Lyon

2025.01.29

Led by PhD Evelyne Decullier (Hospices Civils de Lyon) the second SHARE-CTD schooling event will take place at Domaine Lyon Saint Joseph from 19th to 25th of October 2025.


First datathon in July 2025 in Göttingen

2024.07.09

Led by Prof. Dr. Ulrich Sax (University Medical Center Göttingen, UMG) the first SHARE-CTD datathon will take place at Rechenzentrum Göttingen from 7th to 11th of July 2025.


Principal Investigators


LMU Charité Göttingen MC HCL Medical University of Vienna University of Padova Université de Rennes UMC Utrecht University of Zürich

Partners


BAYER AG DIfE ecrin LORIER
METRICS nfdi NICE The Ottawa Hospital
SciCrunch SMART DATA YODA ZB MED

Associated Universities


University of Amsterdam Universität Göttingen Université de Lyon Utrecht University