Sharing and re-using clinical trial data to maximise impact

Resultado final

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

Publicaciones

Data Management Examples

Autores: Sax, Ulrich
Publicado en: 2024
DOI: 10.5281/ZENODO.14418140

Meta-research (clinical research)

Autores: Naudet, Florian
Publicado en: 2025
DOI: 10.5281/ZENODO.17843819

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

Autores: 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
Publicado en: Nature Medicine, 2024
DOI: 10.1038/S41591-024-02879-X

FAIR data

Autores: Sax, Ulrich
Publicado en: 2024
DOI: 10.5281/ZENODO.14417597

FAIRification of biomedical research data

Autores: Tai, Ka Hin
Publicado en: 2026
DOI: 10.5281/ZENODO.18210629

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

Autores: Weissgerber, Tracey
Publicado en: 2025
DOI: 10.5281/ZENODO.17909420

Interventional Research on Research to improve research value

Autores: Boutron, Isabelle
Publicado en: 2025
DOI: 10.5281/ZENODO.17879753

Training the Next Generation of Researchers in Clinical Data Sharing

Autores: Mansmann, Ulrich
Publicado en: 2025
DOI: 10.5281/ZENODO.17078687

Data protection and participant level data access models

Autores: Prasser, Fabian
Publicado en: 2025
DOI: 10.5281/ZENODO.17840820

Datathon 2: field expertise

Autores: Naudet, Florian
Publicado en: 2025
DOI: 10.5281/ZENODO.17843855

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

Autores: Leonhard Held
Publicado en: 2026
DOI: 10.5281/ZENODO.1906483

Datasharing and marginalized groups

Autores: De Souza Ferraz, Dulce Aurelia
Publicado en: 2025
DOI: 10.5281/ZENODO.17896860

Using meta-research to improve your science

Autores: Weissgerber, Tracey
Publicado en: 2024
DOI: 10.5281/ZENODO.14469997

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

Autores: Mansmann, Ulrich; de Jong, Valentijn; König, Franz; Sax, Ulrich; Naudet, Florian; Held, Leonhard
Publicado en: 2026
DOI: 10.5281/ZENODO.18196665

Reusing clinical trial data to consolidate and advance medical knowledge

Autores: Giulia Varvarà, Cora Burgwinkel, Clara Locher, Joseph S. Ross, Ulrich Mansmann, Florian Naudet
Publicado en: Journal of Clinical Epidemiology, Edición 188, 2025, ISSN 0895-4356
Editor: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111984

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

Autores: Cora Burgwinkel, Manon Gicquel, Isabelle Boutron, Sylvie Chevret, Leonhard Held, David Moher, Florian Naudet, Clara Locher
Publicado en: BMC Medicine, 2026, ISSN 1741-7015
Editor: 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

Autores: Amani Al Tawil, Sean McGrath, Robin Ristl, Ulrich Mansmann
Publicado en: BMC Medical Research Methodology, Edición 24, 2024, ISSN 1471-2288
Editor: 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

Autores: 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
Publicado en: Nature Medicine, Edición 29, 2023, ISSN 1078-8956
Editor: Springer Science and Business Media LLC
DOI: 10.1038/S41591-022-02080-Y

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

Autores: 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
Publicado en: Trials, 2026, ISSN 1745-6215
Editor: Springer Science and Business Media LLC
DOI: 10.1186/S13063-026-0964

Data management and sharing

Autores: Claude Pellen, Nchangwi Syntia Munung, Anna Catharina Armond, Daniel Kulp, Ulrich Mansmann, Maximilian Siebert, Florian Naudet
Publicado en: Journal of Clinical Epidemiology, Edición 180, 2025, ISSN 0895-4356
Editor: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111680

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

Autores: Joseph S. Ross, Joanne Waldstreicher, Harlan M. Krumholz
Publicado en: New England Journal of Medicine, Edición 389, 2023, ISSN 0028-4793
Editor: Massachusetts Medical Society
DOI: 10.1056/NEJMP2308792

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

Autores: Alessandra Gaia Saracini, Leonhard Held
Publicado en: Statistics in Medicine, Edición 44, 2025, ISSN 0277-6715
Editor: Wiley
DOI: 10.1002/SIM.70238

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

Autores: Chunwei Lyu, Minoo Matbouriahi, Florian Naudet, John P. A. Ioannidis, Ioana Alina Cristea
Publicado en: JAMA Network Open, Edición 9, 2026, ISSN 2574-3805
Editor: American Medical Association (AMA)
DOI: 10.1001/JAMANETWORKOPEN.2026.7424

Open science must include effective results dissemination to study participants

Autores: Ka Hin Tai, Gérard Legoff, Anne Le Louarn, Nchangwi Syntia Munung, Florian Naudet
Publicado en: PLOS Medicine, Edición 22, 2025, ISSN 1549-1676
Editor: Public Library of Science (PLoS)
DOI: 10.1371/JOURNAL.PMED.1004780

FAIRification of biomedical research data

Autores: 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
Publicado en: Journal of Clinical Epidemiology, Edición 187, 2025, ISSN 0895-4356
Editor: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111920

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

Autores: 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
Publicado en: Trials, Edición 27, 2026, ISSN 1745-6215
Editor: 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

Autores: Chunwei Lyu, Minoo Matbouriahi, Florian Naudet, John P. A. Ioannidis, Ioana Alina Cristea
Publicado en: JAMA Network Open, Edición 9, 2026, ISSN 2574-3805
Editor: American Medical Association (AMA)
DOI: 10.1001/JAMANETWORKOPEN.2026.7424

Open science must include effective results dissemination to study participants

Autores: Ka Hin Tai, Gérard Legoff, Anne Le Louarn, Nchangwi Syntia Munung, Florian Naudet
Publicado en: PLOS Medicine, Edición 22, 2025, ISSN 1549-1676
Editor: 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

Autores: Begüm Irmak Ön, Joachim Havla, Ulrich Mansmann
Publicado en: Multiple Sclerosis and Related Disorders, Edición 93, 2025, ISSN 2211-0348
Editor: Elsevier BV
DOI: 10.1016/J.MSARD.2024.106247

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

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

FAIRification of biomedical research data

Autores: 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
Publicado en: Journal of Clinical Epidemiology, Edición 187, 2025, ISSN 0895-4356
Editor: 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

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

Reusing clinical trial data to consolidate and advance medical knowledge

Autores: Giulia Varvarà, Cora Burgwinkel, Clara Locher, Joseph S. Ross, Ulrich Mansmann, Florian Naudet
Publicado en: Journal of Clinical Epidemiology, Edición 188, 2025, ISSN 0895-4356
Editor: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111984

Resultado final

Publicaciones

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