Project description
Empowering clinical research through responsible data sharing
In the realm of medical research, valuable clinical information derived from data in clinical trials remains underutilised due to inadequate data sharing practices. This scarcity of responsible data sharing leads to inefficiencies and wastage in the pursuit of scientific breakthroughs. In this context, the EU-funded SHARE-CTD project will address this issue through a multidimensional approach built on ethical, scientific, and governance principles. It aims to enhance data sharing with researchers, improve public access to clinical study information, and foster transparency with patients participating in trials. By certifying procedures for sharing clinical trial data and reaffirming commitments to publish results, the project will increase the efficiency of medical research while training experts specialised in clinical trial transparency and reproducible research practices.
Objective
Data from clinical trials are a rich source of clinical information, highly structured and clearly explained by the accompanying protocols. Responsible sharing of such data holds incredible promises to increase value and decrease waste in medical research. It is built on principles (ethical, scientific), governance structures, skills, and operation infrastructure. Clinical trial data sharing (CTDS) is an emerging activity in academia as well as in the pharmaceutical industry. Both communities develop models for organising and performing CTDS. Thereby, several issues gain relevance: enhancing data sharing with researchers, improving public access to clinical study information, sharing results with patients participating in clinical trials, certifying procedures for sharing clinical trial information, and reaffirming commitments to publish clinical trial results. We see a developing field of professional activities that need well educated experts to define and implement best practices. Training such a new generation of experts in CTDS requires specific teachings with a focus on clinical trial transparency and reproducible research practices. It should include topics such as clinical trials regulations, ethical, legal, and social issues, informatics, data science, biostatistics, and meta-research, as well as domain expertise across different medical fields. In order to gain a deep understanding of this developing field, research activities should be based on meta-research approaches. Those activities focus on research on best practices for CTDS, developing methods to make efficient use of shared data (e.g. methods to augment randomised clinical trials, perform independent participant data meta-analysis, or estimate personalised treatment effects) and measuring CTDS impact.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques.
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Keywords
Programme(s)
- HORIZON.1.2 - Marie Skłodowska-Curie Actions (MSCA) Main Programme
Funding Scheme
HORIZON-TMA-MSCA-DN - HORIZON TMA MSCA Doctoral NetworksCoordinator
80539 MUNCHEN
Germany
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Participants (7)
35042 Rennes
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10117 Berlin
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37075 Goettingen
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1090 Wien
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35122 Padova
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69002 Lyon
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3584 CX Utrecht
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Partners (16)
Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
8006 Zurich
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K1Y 4E9 Ottawa Ontario
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94305 2004 Stanford
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06520 8337 New Haven
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75014 Paris
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Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
1081 HV Amsterdam
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51373 Leverkusen
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92192-8191 San Diego
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50931 Cologne
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M1 4BT Manchester
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14558 Nuthetal
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Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
3524 HM Utrecht
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Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
75654 Paris
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Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
69622 Villeurbanne Cedex
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Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
3584 CS Utrecht
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Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
37073 Gottingen
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