Sharing individual participant data from clinical trials : an opinion survey regarding the establishment of a central repository

Catrin Tudur Smith, Kerry Dwan, Douglas G. Altman, Mike Clarke, Richard Riley, Paula R. Williamson

    Research output: Contribution to journalArticlepeer-review

    30 Citations (Scopus)
    207 Downloads (Pure)

    Abstract

    Calls have been made for increased access to individual participant data (IPD) from clinical trials, to ensure that complete evidence is available. However, despite the obvious benefits, progress towards this is frustratingly slow. In the meantime, many systematic reviews have already collected IPD from clinical trials. We propose that a central repository for these IPD should be established to ensure that these datasets are safeguarded and made available for use by others, building on the strengths and advantages of the collaborative groups that have been brought together in developing the datasets.

    Objective

    Evaluate the level of support, and identify major issues, for establishing a central repository of IPD.

    Design

    On-line survey with email reminders.

    Participants

    71 reviewers affiliated with the Cochrane Collaboration's IPD Meta-analysis Methods Group were invited to participate.

    Results

    30 (42%) invitees responded: 28 (93%) had been involved in an IPD review and 24 (80%) had been involved in a randomised trial. 25 (83%) agreed that a central repository was a good idea and 25 (83%) agreed that they would provide their IPD for central storage. Several benefits of a central repository were noted: safeguarding and standardisation of data, increased efficiency of IPD meta-analyses, knowledge advancement, and facilitating future clinical, and methodological research. The main concerns were gaining permission from trial data owners, uncertainty about the purpose of the repository, potential resource implications, and increased workload for IPD reviewers. Restricted access requiring approval, data security, anonymisation of data, and oversight committees were highlighted as issues under governance of the repository.

    Conclusion

    There is support in this community of IPD reviewers, many of whom are also involved in clinical trials, for storing IPD in a central repository. Results from this survey are informing further work on developing a repository of IPD which is currently underway by our group.
    Original languageEnglish
    Article numbere97886
    JournalPLoS ONE
    Volume9
    Issue number5
    DOIs
    Publication statusPublished - 29 May 2014

    Keywords

    • Clinical trials
    • Data processing
    • Drug therapy
    • Epilepsy
    • Meta-analysis
    • Statistical data
    • Surveys
    • Systematic reviews

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