Environmental scan of repositories of clinical research data: how far have we got with public disclosure of trial data?
There is growing interest in sharing of research data, as data sharing is expected to accelerate research and increase accountability. Sharing of data underlying published research is an increasingly important consideration for peer-reviewed journals, and some journals require researchers to state their data sharing policy in published articles. However, the field of clinical trials has been slow to adopt a culture of data transparency.
Data repositories are vital for achieving broad data sharing but in clinical research there is no widely-used repository for raw data which covers a variety of medical disciplines. Furthermore, to our knowledge there is no wide agreement on the standards, best practices and essential features of clinical data repositories.
Dr Karmela Krleza-Jeric and BioMed Central will be seeking to address these gaps in knowledge. The project aims to produce comprehensive information on the features and practices of data repositories with interests in clinical data disclosure.
The methodology of the study will include reviewing existing resources that catalogue information on data repositories, such as Databib, literature review, analysis of websites of repositories, and engagement of relevant stakeholders – such as interviews with repository managers.
We will aim to capture any methods of existing repositories for public disclosure of clinical data and non-public forms of data sharing, such as the unique and persistent identification systems for datasets; the data license, use or other agreements employed by the repositories; and the sustainability (business) models employed. We aim to understand how repositories have addressed these issues and summarize what are considered good practices.
The results and findings of this study will be made publicly available and used to inform the elaboration of another study which aims to develop a methodology for data sharing from clinical trials, as well as standards and guidelines for data repositories involved in the public disclosure of participant level datasets from clinical trials.
We hope the study outcomes will encourage collaboration between repositories on areas of common interest and foster collaboration between journals, publishers and data repositories to help enhance the reliability and connectedness of the scientific literature.