A multi-stakeholder task force developed a consensus document on providing access to individual participant data from clinical trials. The task force used a broad interdisciplinary approach after examining major issues associated with sharing of individual clinical trial data.
The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains.
This consensus-building process involved a wide range of experts like researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations. The project was coordinated by the European Clinical Research Infrastructure Network (ECRIN), thus, the focus was on non-commercial trials and the perspective mainly European.
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