How far have we got with public disclosure of trial data?

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BioMed Central in collaboration with an Ottawa-based researcher has received the Committee on Publication Ethics (COPE) research grant for a timely project which aims to facilitate wider sharing of clinical research data.

In the last few weeks GlaxoSmithKline and Medtronic have made public commitments to share data from clinical trials they have sponsored, the BMJ have strengthened their policy on data sharing for clinical trial submissions, and Ben Goldacre‘s latest book, Bad Pharma, is causing something of a stir. These are significant and much-needed developments in transparency in clinical research.

Researchers working with human subjects are amongst the least likely to share their data, and the practicalities and legalities of sharing clinical data while protecting patient privacy may be part of the reason. In other words, even if there is a will to share, there may not be an obvious way to share.

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, ‘Environmental scan of repositories of clinical research data: how far have we got with public disclosure of trial data?’, 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.

We want to collaborate with repository managers and the wider clinical research community during the project so encourage anyone who feels they can help to contact us. The executive summary for the project is available here.

  • networkpharmacology

    The creation of open databases containing clinical data for public examination by all researchers would be great step forward.

    It is hoped that those collating the data and asking researchers to record the data take heed of the requirements of new approaches to drug discovery as well as existing paradigm.

    Specifically this means:

    Protein interaction data correlated to:

    Specific phenotypes
    Disease state
    Genetic differences
    Age, race

    plus a uniform nomenclature for proteins.

    This would prove an invaluable resource for network pharmacology studies of disease accelerating progress of understanding and the identification of effective mode of action and disease progression.