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

CORDIS provides links to public deliverables and publications of HORIZON projects.

Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Deliverables

Demonstrators, pilots, prototypes (4)

Schooling (2)

Best practices in CTDS and Meta Research

Professional Training (1)

soft skills - Participants: LMU (writing skills, communication and moderation skills); Charité (gender sensitivity, interacting into a multicultural setting, stress management and wellbeing; team building skills, success skills, kills to use social media for science communication)

Schooling (1)

Data management and analytical skills for sharer/re-users

Propaedeutic

Introducing DCs into the basic methodological and conceptual aspects of the DN

Documents, reports (3)

Stakeholder Dialogue

Plan and execute stakeholder dialogues (where patient groups will also participate for an implementation strategy for scaling up CTDS: Stakeholder dialogue is started: interviews with scientific societies are perfomed, focus groups have been organised.(See Table 3.1 c D6.2 in SHARE-CTD Proposal)

Scoping Review

Conduct a scoping review of European policies on CTDS and provide a manuscript.(See Table 3.1 c D6.1 in SHARE-CTD Proposal)

Pipelines and Datathons (1)

Datathon (1) is organised: Re-analysing clinical trial data, practicing theprovision and usage of data to be shared. Data will be provided by our partner Yale University (YODA) and UMCU. Results are presented in a paper.(See Table 3.1 c D5.4 in SHARE-CTD Proposal)

Websites, patent fillings, videos etc. (1)

Website

Project website

Publications

Other (14)

Data Management Examples

Author(s): Sax, Ulrich
Published in: 2024
DOI: 10.5281/ZENODO.14418140

Meta-research (clinical research)

Author(s): Naudet, Florian
Published in: 2025
DOI: 10.5281/ZENODO.17843819

Understanding the provenance and quality of methods is essential for responsible reuse of FAIR data

Author(s): Tracey L. Weissgerber; Małgorzata Anna Gazda; Gustav Nilsonne; Gerben ter Riet; Kelly D. Cobey; Julia Prieß-Buchheit; Jorge Noro; Robert Schulz; Joeri K. Tijdink; Evgeny Bobrov; Alexandra Bannach-Brown; Delwen L. Franzen; Ugo Moschini; Florian Naudet; Ulrich Mansmann; Maia Salholz-Hillel; Anita Bandrowski; Malcolm R. Macleod
Published in: Nature Medicine, 2024
DOI: 10.1038/S41591-024-02879-X

FAIR data

Author(s): Sax, Ulrich
Published in: 2024
DOI: 10.5281/ZENODO.14417597

FAIRification of biomedical research data

Author(s): Tai, Ka Hin
Published in: 2026
DOI: 10.5281/ZENODO.18210629

Building better research: Changing research systems by introducing graduate incentives for openness, reusability and reproducibility

Author(s): Weissgerber, Tracey
Published in: 2025
DOI: 10.5281/ZENODO.17909420

Interventional Research on Research to improve research value

Author(s): Boutron, Isabelle
Published in: 2025
DOI: 10.5281/ZENODO.17879753

Training the Next Generation of Researchers in Clinical Data Sharing

Author(s): Mansmann, Ulrich
Published in: 2025
DOI: 10.5281/ZENODO.17078687

Data protection and participant level data access models

Author(s): Prasser, Fabian
Published in: 2025
DOI: 10.5281/ZENODO.17840820

Datathon 2: field expertise

Author(s): Naudet, Florian
Published in: 2025
DOI: 10.5281/ZENODO.17843855

How Good Research Data Management Enables Reproducibility and Data Reuse: A Case Study of Clinical Trial Data

Author(s): Leonhard Held
Published in: 2026
DOI: 10.5281/ZENODO.1906483

Datasharing and marginalized groups

Author(s): De Souza Ferraz, Dulce Aurelia
Published in: 2025
DOI: 10.5281/ZENODO.17896860

Using meta-research to improve your science

Author(s): Weissgerber, Tracey
Published in: 2024
DOI: 10.5281/ZENODO.14469997

Reply to Trinquart and Stockler's comments on clinical trial data sharing.

Author(s): Mansmann, Ulrich; de Jong, Valentijn; König, Franz; Sax, Ulrich; Naudet, Florian; Held, Leonhard
Published in: 2026
DOI: 10.5281/ZENODO.18196665

Peer reviewed articles (19)

Reusing clinical trial data to consolidate and advance medical knowledge

Author(s): Giulia Varvarà, Cora Burgwinkel, Clara Locher, Joseph S. Ross, Ulrich Mansmann, Florian Naudet
Published in: Journal of Clinical Epidemiology, Issue 188, 2025, ISSN 0895-4356
Publisher: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111984

Introducing the need for a consensus-based framework for protocol modifications to improve trial trustworthiness

Author(s): Cora Burgwinkel, Manon Gicquel, Isabelle Boutron, Sylvie Chevret, Leonhard Held, David Moher, Florian Naudet, Clara Locher
Published in: BMC Medicine, 2026, ISSN 1741-7015
Publisher: Springer Science and Business Media LLC
DOI: 10.1186/S12916-026-04831-X

Addressing treatment switching in the ALTA-1L trial with g-methods: exploring the impact of model specification

Author(s): Amani Al Tawil, Sean McGrath, Robin Ristl, Ulrich Mansmann
Published in: BMC Medical Research Methodology, Issue 24, 2024, ISSN 1471-2288
Publisher: Springer Science and Business Media LLC
DOI: 10.1186/S12874-024-02437-6

Implementing clinical trial data sharing requires training a new generation of biomedical researchers

Author(s): Ulrich Mansmann, Clara Locher, Fabian Prasser, Tracey Weissgerber, Ulrich Sax, Martin Posch, Evelyne Decullier, Ioana A. Cristea, Thomas P. A. Debray, Leonhard Held, David Moher, John P. A. Ioannidis, Joseph S. Ross, Christian Ohmann, Florian Naudet
Published in: Nature Medicine, Issue 29, 2023, ISSN 1078-8956
Publisher: Springer Science and Business Media LLC
DOI: 10.1038/S41591-022-02080-Y

Supporting reanalysis and reuse of clinical trial data: a case study

Author(s): Cora Burgwinkel, Han Chang Chiam, Ka Hin Tai, Jifan Wang, Mian Haider Ali, Salman Soleiman Fallah, Minoo Matbouriahi, Tobechi Obinwanne, Grigorios Papapostolou, Muhammad Riedha, Giulia Varvara, Yazid Zalai, Ulrich Mansmann, Ulrich Sax, Leonhard Held
Published in: Trials, 2026, ISSN 1745-6215
Publisher: Springer Science and Business Media LLC
DOI: 10.1186/S13063-026-0964

Data management and sharing

Author(s): Claude Pellen, Nchangwi Syntia Munung, Anna Catharina Armond, Daniel Kulp, Ulrich Mansmann, Maximilian Siebert, Florian Naudet
Published in: Journal of Clinical Epidemiology, Issue 180, 2025, ISSN 0895-4356
Publisher: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111680

Data Sharing — A New Era for Research Funded by the U.S. Government

Author(s): Joseph S. Ross, Joanne Waldstreicher, Harlan M. Krumholz
Published in: New England Journal of Medicine, Issue 389, 2023, ISSN 0028-4793
Publisher: Massachusetts Medical Society
DOI: 10.1056/NEJMP2308792

Addressing Outcome Reporting Bias in Meta‐Analysis: A Selection Model Perspective

Author(s): Alessandra Gaia Saracini, Leonhard Held
Published in: Statistics in Medicine, Issue 44, 2025, ISSN 0277-6715
Publisher: Wiley
DOI: 10.1002/SIM.70238

Retracted Randomized Clinical Trials From Superretractors and Top-Cited Scientists With Multiple Retractions

Author(s): Chunwei Lyu, Minoo Matbouriahi, Florian Naudet, John P. A. Ioannidis, Ioana Alina Cristea
Published in: JAMA Network Open, Issue 9, 2026, ISSN 2574-3805
Publisher: American Medical Association (AMA)
DOI: 10.1001/JAMANETWORKOPEN.2026.7424

Open science must include effective results dissemination to study participants

Author(s): Ka Hin Tai, Gérard Legoff, Anne Le Louarn, Nchangwi Syntia Munung, Florian Naudet
Published in: PLOS Medicine, Issue 22, 2025, ISSN 1549-1676
Publisher: Public Library of Science (PLoS)
DOI: 10.1371/JOURNAL.PMED.1004780

FAIRification of biomedical research data

Author(s): Ka Hin Tai, Marcel Müller, Ulrich Mansmann, Anna Catharina Vieira Armond, Evelyne Decullier, Anne Le Louarn, Nchangwi Syntia Munung, Florian Naudet, Fabian Prasser, Ulrich Sax
Published in: Journal of Clinical Epidemiology, Issue 187, 2025, ISSN 0895-4356
Publisher: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111920

Supporting reanalysis and reuse of clinical trial data: a case study

Author(s): Cora Burgwinkel, Han Chang Chiam, Ka Hin Tai, Jifan Wang, Mian Haider Ali, Salman Soleiman Fallah, Minoo Matbouriahi, Tobechi Obinwanne, Grigorios Papapostolou, Muhammad Riedha, Giulia Varvara, Yazid Zalai, Ulrich Mansmann, Ulrich Sax, Leonhard Held
Published in: Trials, Issue 27, 2026, ISSN 1745-6215
Publisher: Springer Science and Business Media LLC
DOI: 10.1186/S13063-026-09646-Y

Retracted Randomized Clinical Trials From Superretractors and Top-Cited Scientists With Multiple Retractions

Author(s): Chunwei Lyu, Minoo Matbouriahi, Florian Naudet, John P. A. Ioannidis, Ioana Alina Cristea
Published in: JAMA Network Open, Issue 9, 2026, ISSN 2574-3805
Publisher: American Medical Association (AMA)
DOI: 10.1001/JAMANETWORKOPEN.2026.7424

Open science must include effective results dissemination to study participants

Author(s): Ka Hin Tai, Gérard Legoff, Anne Le Louarn, Nchangwi Syntia Munung, Florian Naudet
Published in: PLOS Medicine, Issue 22, 2025, ISSN 1549-1676
Publisher: Public Library of Science (PLoS)
DOI: 10.1371/JOURNAL.PMED.1004780

Multivariable prognostic prediction of efficacy and safety outcomes and response to fingolimod in people with relapsing-remitting multiple sclerosis

Author(s): Begüm Irmak Ön, Joachim Havla, Ulrich Mansmann
Published in: Multiple Sclerosis and Related Disorders, Issue 93, 2025, ISSN 2211-0348
Publisher: Elsevier BV
DOI: 10.1016/J.MSARD.2024.106247

Introducing the need for a consensus-based framework for protocol modifications to improve trial trustworthiness

Author(s): Cora Burgwinkel, Manon Gicquel, Isabelle Boutron, Sylvie Chevret, Leonhard Held, David Moher, Florian Naudet, Clara Locher
Published in: BMC Medicine, 2026, ISSN 1741-7015
Publisher: Springer Science and Business Media LLC
DOI: 10.1186/S12916-026-04831-X

FAIRification of biomedical research data

Author(s): Ka Hin Tai, Marcel Müller, Ulrich Mansmann, Anna Catharina Vieira Armond, Evelyne Decullier, Anne Le Louarn, Nchangwi Syntia Munung, Florian Naudet, Fabian Prasser, Ulrich Sax
Published in: Journal of Clinical Epidemiology, Issue 187, 2025, ISSN 0895-4356
Publisher: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111920

Efficacy and safety of esketamine for “treatment resistant depression”: registered report for a systematic review with an individual patient data meta-analysis of randomized, double-blind, placebo-controlled trials

Author(s): Florian Naudet, Claude Pellen, Liviu A. Fodor, Chiara Gastaldon, Corrado Barbui, Erick H. Turner, Estelle Le Pabic, Ioana A. Cristea
Published in: BMC Medicine, Issue 23, 2025, ISSN 1741-7015
Publisher: Springer Science and Business Media LLC
DOI: 10.1186/S12916-025-04435-X

Reusing clinical trial data to consolidate and advance medical knowledge

Author(s): Giulia Varvarà, Cora Burgwinkel, Clara Locher, Joseph S. Ross, Ulrich Mansmann, Florian Naudet
Published in: Journal of Clinical Epidemiology, Issue 188, 2025, ISSN 0895-4356
Publisher: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111984