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SHARE-CTD

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Sharing and re-using clinical trial data to maximise impact

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... ver más

31/12/2027

LMU MUENCHEN

Presupuesto desconocido

Líder del proyecto

LUDWIGMAXIMILIANSUNIVERSITAET MUENCHEN No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Financiación concedida El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2024-01-01

HORIZON-MSCA-2022-DN-01-01: MSCA Doctoral Networks 2022 ExpectedOutcome:Project results are expected to contribute to the following outcomes:

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Cerrada hace 2 años

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No hay información privada compartida para este proyecto. Habla con el coordinador.

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LMU MUENCHEN

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Duración del proyecto: 47 meses Fecha Inicio: 2024-01-01
Fecha Fin: 2027-12-31

Líder del proyecto

LUDWIGMAXIMILIANSUNIVERSITAET MUENCHEN No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto 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.

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