Sharing and re-using clinical trial data to maximise impact

Risultati finali

Best practices in CTDS and Meta Research

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

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)

Website

Project website

Pubblicazioni

Data Management Examples

Autori: Sax, Ulrich
Pubblicato in: 2024
DOI: 10.5281/ZENODO.14418140

Meta-research (clinical research)

Autori: Naudet, Florian
Pubblicato in: 2025
DOI: 10.5281/ZENODO.17843819

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

Autori: 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
Pubblicato in: Nature Medicine, 2024
DOI: 10.1038/S41591-024-02879-X

FAIR data

Autori: Sax, Ulrich
Pubblicato in: 2024
DOI: 10.5281/ZENODO.14417597

FAIRification of biomedical research data

Autori: Tai, Ka Hin
Pubblicato in: 2026
DOI: 10.5281/ZENODO.18210629

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

Autori: Weissgerber, Tracey
Pubblicato in: 2025
DOI: 10.5281/ZENODO.17909420

Interventional Research on Research to improve research value

Autori: Boutron, Isabelle
Pubblicato in: 2025
DOI: 10.5281/ZENODO.17879753

Training the Next Generation of Researchers in Clinical Data Sharing

Autori: Mansmann, Ulrich
Pubblicato in: 2025
DOI: 10.5281/ZENODO.17078687

Data protection and participant level data access models

Autori: Prasser, Fabian
Pubblicato in: 2025
DOI: 10.5281/ZENODO.17840820

Datathon 2: field expertise

Autori: Naudet, Florian
Pubblicato in: 2025
DOI: 10.5281/ZENODO.17843855

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

Autori: Leonhard Held
Pubblicato in: 2026
DOI: 10.5281/ZENODO.1906483

Datasharing and marginalized groups

Autori: De Souza Ferraz, Dulce Aurelia
Pubblicato in: 2025
DOI: 10.5281/ZENODO.17896860

Using meta-research to improve your science

Autori: Weissgerber, Tracey
Pubblicato in: 2024
DOI: 10.5281/ZENODO.14469997

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

Autori: Mansmann, Ulrich; de Jong, Valentijn; König, Franz; Sax, Ulrich; Naudet, Florian; Held, Leonhard
Pubblicato in: 2026
DOI: 10.5281/ZENODO.18196665

Reusing clinical trial data to consolidate and advance medical knowledge

Autori: Giulia Varvarà, Cora Burgwinkel, Clara Locher, Joseph S. Ross, Ulrich Mansmann, Florian Naudet
Pubblicato in: Journal of Clinical Epidemiology, Numero 188, 2025, ISSN 0895-4356
Editore: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111984

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

Autori: Cora Burgwinkel, Manon Gicquel, Isabelle Boutron, Sylvie Chevret, Leonhard Held, David Moher, Florian Naudet, Clara Locher
Pubblicato in: BMC Medicine, 2026, ISSN 1741-7015
Editore: 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

Autori: Amani Al Tawil, Sean McGrath, Robin Ristl, Ulrich Mansmann
Pubblicato in: BMC Medical Research Methodology, Numero 24, 2024, ISSN 1471-2288
Editore: 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

Autori: 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
Pubblicato in: Nature Medicine, Numero 29, 2023, ISSN 1078-8956
Editore: Springer Science and Business Media LLC
DOI: 10.1038/S41591-022-02080-Y

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

Autori: 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
Pubblicato in: Trials, 2026, ISSN 1745-6215
Editore: Springer Science and Business Media LLC
DOI: 10.1186/S13063-026-0964

Data management and sharing

Autori: Claude Pellen, Nchangwi Syntia Munung, Anna Catharina Armond, Daniel Kulp, Ulrich Mansmann, Maximilian Siebert, Florian Naudet
Pubblicato in: Journal of Clinical Epidemiology, Numero 180, 2025, ISSN 0895-4356
Editore: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111680

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

Autori: Joseph S. Ross, Joanne Waldstreicher, Harlan M. Krumholz
Pubblicato in: New England Journal of Medicine, Numero 389, 2023, ISSN 0028-4793
Editore: Massachusetts Medical Society
DOI: 10.1056/NEJMP2308792

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

Autori: Alessandra Gaia Saracini, Leonhard Held
Pubblicato in: Statistics in Medicine, Numero 44, 2025, ISSN 0277-6715
Editore: Wiley
DOI: 10.1002/SIM.70238

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

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

Open science must include effective results dissemination to study participants

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

FAIRification of biomedical research data

Autori: 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
Pubblicato in: Journal of Clinical Epidemiology, Numero 187, 2025, ISSN 0895-4356
Editore: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111920

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

Autori: 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
Pubblicato in: Trials, Numero 27, 2026, ISSN 1745-6215
Editore: 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

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

Open science must include effective results dissemination to study participants

Autori: Ka Hin Tai, Gérard Legoff, Anne Le Louarn, Nchangwi Syntia Munung, Florian Naudet
Pubblicato in: PLOS Medicine, Numero 22, 2025, ISSN 1549-1676
Editore: 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

Autori: Begüm Irmak Ön, Joachim Havla, Ulrich Mansmann
Pubblicato in: Multiple Sclerosis and Related Disorders, Numero 93, 2025, ISSN 2211-0348
Editore: Elsevier BV
DOI: 10.1016/J.MSARD.2024.106247

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

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

FAIRification of biomedical research data

Autori: 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
Pubblicato in: Journal of Clinical Epidemiology, Numero 187, 2025, ISSN 0895-4356
Editore: 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

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

Reusing clinical trial data to consolidate and advance medical knowledge

Autori: Giulia Varvarà, Cora Burgwinkel, Clara Locher, Joseph S. Ross, Ulrich Mansmann, Florian Naudet
Pubblicato in: Journal of Clinical Epidemiology, Numero 188, 2025, ISSN 0895-4356
Editore: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111984

Risultati finali

Pubblicazioni

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