Clinical trial transparency and data repositories; an environmental scan of the IMPACT (Improving Access to Clinical Trial Data) Observatory

The ongoing call for opening and reanalysis of clinical trial data is expected to contribute to higher reliability of evidence gained by systematic reviews and meta-analysis.

Research data repositories (repositories) are digital repositories that store datasets and metadata on the Internet. They enable researchers to share data and are an essential role in increasing the accessibility and reusability of research data.

The objective of the IMPACT Observatory is to identify and analyze characteristics of repositories that host clinical trial data, including barriers and gaps in data sharing practice. The findings will inform the scientific community at conferences, in publications, and by posting them on the website.

Methodology
Environmental scanning consists of collecting and analysing information about an environment, that can be used in planning and development. Our methodology included the identification of repositories that host clinical trial data and analysing their characteristics in excel. We searched for repositories by reviewing Re3data registry of research data repositories, Google search engine, and by direct communication. The information gathered from repositories’ websites was complemented by contacting repositories managers.

We found no clinical trial domain repository, but there are repositories that host any research data including clinical trial data. We identified and analyzed basic features of 11 such repositories in the public domain. All repositories assign a unique identifier. However, there is no defined methodology or internationally accepted standard on how to prepare, post and access clinical trial data in the repository. Consequently, there is heterogeneity regarding uploading and access for reuse of data as well as of curatorship.

Repositories can play an important role in opening of clinical trial data by increasing the accessibility of data and facilitating its reuse. However a development of data sharing standards is essential.