Sharing and reuse of individual participant data from clinical trials: principles and recommendations
Sharing and re-using Individual Patient Data from a trial is an attractive proposition, sparking several organisations to call for increased availability of such data generated by publicly funded research in recent years.
Having access to such data would allow to be compared and combined from different studies, aggregated for meta-analysis and could mean less duplication of effort across the field, reinforcing trust in trial outcome and publication.
However, there are many challenges to be overcome on the path to transparency including participant privacy, participant consent or data interoperability.
That is why we’re pleased to share that on the last 12 months, ECRIN (European Clinical Research Infrastructure Network), organised multiple workshops with experts ranging from researchers to patient representatives or technology experts, and funders, to discuss the subject.
As a result 10 principles and 50 recommendations, representing the fundamental requirements for sharing individual clinical trials data, were drafted. The recommendations now need to be implemented and tested in practice.
You can find out more by reading the open access article is available online.
This work results from the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services).