Projects per year
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.
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 language | English |
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Article number | e97886 |
Journal | PLoS ONE |
Volume | 9 |
Issue number | 5 |
DOIs | |
Publication status | Published - 29 May 2014 |
Keywords
- Clinical trials
- Data processing
- Drug therapy
- Epilepsy
- Meta-analysis
- Statistical data
- Surveys
- Systematic reviews
Fingerprint
Dive into the research topics of 'Sharing individual participant data from clinical trials : an opinion survey regarding the establishment of a central repository'. Together they form a unique fingerprint.Projects
- 2 Finished
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Linked to RRAK13548: Midland Hub for Trials Methodology Research
1/04/11 → 31/03/14
Project: Research Councils
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Linked to a/c DJAB RRAK13548 - Midland Hub for Trials Methodology Research at University of Birmingham
Billingham, L., Bryan, S., Calvert, M., Deeks, J., Delaney, B., Freemantle, N., Gray, R., Hobbs, R., Johnson, P., Lilford, R., Wheatley, K. & Zeegers, M.
1/06/09 → 31/05/14
Project: Research Councils