Sharing and re-using clinical trial data to maximise impact

Rezultaty

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

Publikacje

Data Management Examples

Autorzy: Sax, Ulrich
Opublikowane w: 2024
DOI: 10.5281/ZENODO.14418140

Meta-research (clinical research)

Autorzy: Naudet, Florian
Opublikowane w: 2025
DOI: 10.5281/ZENODO.17843819

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

Autorzy: 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
Opublikowane w: Nature Medicine, 2024
DOI: 10.1038/S41591-024-02879-X

FAIR data

Autorzy: Sax, Ulrich
Opublikowane w: 2024
DOI: 10.5281/ZENODO.14417597

FAIRification of biomedical research data

Autorzy: Tai, Ka Hin
Opublikowane w: 2026
DOI: 10.5281/ZENODO.18210629

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

Autorzy: Weissgerber, Tracey
Opublikowane w: 2025
DOI: 10.5281/ZENODO.17909420

Interventional Research on Research to improve research value

Autorzy: Boutron, Isabelle
Opublikowane w: 2025
DOI: 10.5281/ZENODO.17879753

Training the Next Generation of Researchers in Clinical Data Sharing

Autorzy: Mansmann, Ulrich
Opublikowane w: 2025
DOI: 10.5281/ZENODO.17078687

Data protection and participant level data access models

Autorzy: Prasser, Fabian
Opublikowane w: 2025
DOI: 10.5281/ZENODO.17840820

Datathon 2: field expertise

Autorzy: Naudet, Florian
Opublikowane w: 2025
DOI: 10.5281/ZENODO.17843855

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

Autorzy: Leonhard Held
Opublikowane w: 2026
DOI: 10.5281/ZENODO.1906483

Datasharing and marginalized groups

Autorzy: De Souza Ferraz, Dulce Aurelia
Opublikowane w: 2025
DOI: 10.5281/ZENODO.17896860

Using meta-research to improve your science

Autorzy: Weissgerber, Tracey
Opublikowane w: 2024
DOI: 10.5281/ZENODO.14469997

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

Autorzy: Mansmann, Ulrich; de Jong, Valentijn; König, Franz; Sax, Ulrich; Naudet, Florian; Held, Leonhard
Opublikowane w: 2026
DOI: 10.5281/ZENODO.18196665

Reusing clinical trial data to consolidate and advance medical knowledge

Autorzy: Giulia Varvarà, Cora Burgwinkel, Clara Locher, Joseph S. Ross, Ulrich Mansmann, Florian Naudet
Opublikowane w: Journal of Clinical Epidemiology, Numer 188, 2025, ISSN 0895-4356
Wydawca: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111984

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

Autorzy: Cora Burgwinkel, Manon Gicquel, Isabelle Boutron, Sylvie Chevret, Leonhard Held, David Moher, Florian Naudet, Clara Locher
Opublikowane w: BMC Medicine, 2026, ISSN 1741-7015
Wydawca: 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

Autorzy: Amani Al Tawil, Sean McGrath, Robin Ristl, Ulrich Mansmann
Opublikowane w: BMC Medical Research Methodology, Numer 24, 2024, ISSN 1471-2288
Wydawca: 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

Autorzy: 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
Opublikowane w: Nature Medicine, Numer 29, 2023, ISSN 1078-8956
Wydawca: Springer Science and Business Media LLC
DOI: 10.1038/S41591-022-02080-Y

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

Autorzy: 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
Opublikowane w: Trials, 2026, ISSN 1745-6215
Wydawca: Springer Science and Business Media LLC
DOI: 10.1186/S13063-026-0964

Data management and sharing

Autorzy: Claude Pellen, Nchangwi Syntia Munung, Anna Catharina Armond, Daniel Kulp, Ulrich Mansmann, Maximilian Siebert, Florian Naudet
Opublikowane w: Journal of Clinical Epidemiology, Numer 180, 2025, ISSN 0895-4356
Wydawca: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111680

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

Autorzy: Joseph S. Ross, Joanne Waldstreicher, Harlan M. Krumholz
Opublikowane w: New England Journal of Medicine, Numer 389, 2023, ISSN 0028-4793
Wydawca: Massachusetts Medical Society
DOI: 10.1056/NEJMP2308792

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

Autorzy: Alessandra Gaia Saracini, Leonhard Held
Opublikowane w: Statistics in Medicine, Numer 44, 2025, ISSN 0277-6715
Wydawca: Wiley
DOI: 10.1002/SIM.70238

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

Autorzy: Chunwei Lyu, Minoo Matbouriahi, Florian Naudet, John P. A. Ioannidis, Ioana Alina Cristea
Opublikowane w: JAMA Network Open, Numer 9, 2026, ISSN 2574-3805
Wydawca: American Medical Association (AMA)
DOI: 10.1001/JAMANETWORKOPEN.2026.7424

Open science must include effective results dissemination to study participants

Autorzy: Ka Hin Tai, Gérard Legoff, Anne Le Louarn, Nchangwi Syntia Munung, Florian Naudet
Opublikowane w: PLOS Medicine, Numer 22, 2025, ISSN 1549-1676
Wydawca: Public Library of Science (PLoS)
DOI: 10.1371/JOURNAL.PMED.1004780

FAIRification of biomedical research data

Autorzy: 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
Opublikowane w: Journal of Clinical Epidemiology, Numer 187, 2025, ISSN 0895-4356
Wydawca: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111920

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

Autorzy: 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
Opublikowane w: Trials, Numer 27, 2026, ISSN 1745-6215
Wydawca: 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

Autorzy: Chunwei Lyu, Minoo Matbouriahi, Florian Naudet, John P. A. Ioannidis, Ioana Alina Cristea
Opublikowane w: JAMA Network Open, Numer 9, 2026, ISSN 2574-3805
Wydawca: American Medical Association (AMA)
DOI: 10.1001/JAMANETWORKOPEN.2026.7424

Open science must include effective results dissemination to study participants

Autorzy: Ka Hin Tai, Gérard Legoff, Anne Le Louarn, Nchangwi Syntia Munung, Florian Naudet
Opublikowane w: PLOS Medicine, Numer 22, 2025, ISSN 1549-1676
Wydawca: 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

Autorzy: Begüm Irmak Ön, Joachim Havla, Ulrich Mansmann
Opublikowane w: Multiple Sclerosis and Related Disorders, Numer 93, 2025, ISSN 2211-0348
Wydawca: Elsevier BV
DOI: 10.1016/J.MSARD.2024.106247

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

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

FAIRification of biomedical research data

Autorzy: 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
Opublikowane w: Journal of Clinical Epidemiology, Numer 187, 2025, ISSN 0895-4356
Wydawca: 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

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

Reusing clinical trial data to consolidate and advance medical knowledge

Autorzy: Giulia Varvarà, Cora Burgwinkel, Clara Locher, Joseph S. Ross, Ulrich Mansmann, Florian Naudet
Opublikowane w: Journal of Clinical Epidemiology, Numer 188, 2025, ISSN 0895-4356
Wydawca: Elsevier BV
DOI: 10.1016/J.JCLINEPI.2025.111984

Rezultaty

Publikacje

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