Sharing and reuse of individual participant data from clinical trials: principles and recommendations

Objectives: We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach.

Design and Methods

This was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts. An independent facilitator supported the process using the nominal group technique.

The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed. This work was set within the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network.

Key Stakeholders Involved

The task force involved researchers, patient representatives, methodologists, information technology experts, and representatives from the following groups:

• Funders
• Infrastructures
• Standards development organisations

Project Framework

Outcome

As a result of this interdisciplinary work, we developed principles and practical recommendations on how to share data from clinical trials.