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Sharing and re-using clinical trial data to maximise impact

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)

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Keywords

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Programme(s)

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Topic(s)

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HORIZON-TMA-MSCA-DN - HORIZON TMA MSCA Doctoral Networks

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Call for proposal

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(opens in new window) HORIZON-MSCA-2022-DN-01

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Coordinator

LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 260 539,20
Address
GESCHWISTER SCHOLL PLATZ 1
80539 MUNCHEN
Germany

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Region
Bayern Oberbayern München, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
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Total cost

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Participants (7)

Partners (16)

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