Transparency and objectivity in governance of clinical trials data sharing: Current practices and approaches

摘要

Sharing metadata, individual participant data and summary data, as a complement to results dissemination and trial registration requirements, is perceived to be advantageous by enabling faster and more accurate meta-analyses and reducing the need for additional trials. To date, various models of data access have been utilized in order to manage clinical trials data sharing and access in line with the rights and interests of sponsors, researchers and patients involved in clinical trials. In order to ensure responsible data sharing, the data access review process should be developed in a way that ensures fairness, transparency and objectivity. In this article, we critically review some examples of current governance models in clinical trials data sharing and suggest approaches to ensure the objectivity of the data access review process.