Sharing Individual Participant Data from Clinical Trials: An Opinion Survey Regarding the Establishment of a Central Repository

Background 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.

[1]  J. Kirwan,et al.  Making original data from clinical studies available for alternative analysis. , 1997, The Journal of rheumatology.

[2]  A. Marson,et al.  Carbamazepine versus valproate monotherapy for epilepsy. , 2000, The Cochrane database of systematic reviews.

[3]  J L Hutton,et al.  Individual patient data meta-analysis of randomized anti-epileptic drug monotherapy trials. , 2000, Journal of evaluation in clinical practice.

[4]  A G Marson,et al.  Phenytoin versus valproate monotherapy for partial onset seizures and generalized onset tonic-clonic seizures. , 2001, The Cochrane database of systematic reviews.

[5]  Catrin Tudur Smith,et al.  Phenobarbitone versus phenytoin monotherapy for partial onset seizures and generalized onset tonic-clonic seizures. , 2001, The Cochrane database of systematic reviews.

[6]  Kim Bartel Sheehan,et al.  E-mail Survey Response Rates: A Review , 2006, J. Comput. Mediat. Commun..

[7]  Paula R Williamson,et al.  Aggregate data meta‐analysis with time‐to‐event outcomes , 2002, Statistics in medicine.

[8]  A. Marson,et al.  Carbamazepine versus phenytoin monotherapy for epilepsy. , 2002, The Cochrane database of systematic reviews.

[9]  Paula R Williamson,et al.  Statistical issues in the assessment of the evidence for an interaction between factors in epilepsy trials , 2002, Statistics in medicine.

[10]  Catrin Tudur Smith,et al.  Carbamazepine versus phenobarbitone monotherapy for epilepsy. , 2003, The Cochrane database of systematic reviews.

[11]  Paula R Williamson,et al.  Investigating heterogeneity in an individual patient data meta‐analysis of time to event outcomes , 2005, Statistics in medicine.

[12]  Deborah M Caldwell,et al.  Simultaneous comparison of multiple treatments: combining direct and indirect evidence , 2005, BMJ : British Medical Journal.

[13]  A G Marson,et al.  Oxcarbazepine versus phenytoin monotherapy for epilepsy. , 2006, The Cochrane database of systematic reviews.

[14]  A. Vickers.  Whose data set is it anyway? Sharing raw data from randomized trials , 2006, Trials.

[15]  Josemir W. Sander,et al.  Competing risks of antiepileptic drug failure: Importance, measurement and analysis , 2006 .

[16]  A. Marson,et al.  Multiple treatment comparisons in epilepsy monotherapy trials , 2007, Trials.

[17]  P. Williamson,et al.  A comparison of methods for fixed effects meta-analysis of individual patient data with time to event outcomes , 2007, Clinical trials.

[18]  David F. Smith,et al.  The SANAD study of effectiveness of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: an unblinded randomised controlled trial , 2007, The Lancet.

[19]  Jing Shen,et al.  The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial , 2007, The Lancet.

[20]  A. Vickers,et al.  Empirical Study of Data Sharing by Authors Publishing in PLoS Journals , 2009, PloS one.

[21]  R. Riley,et al.  Meta-analysis of individual participant data: rationale, conduct, and reporting , 2010, BMJ : British Medical Journal.

[22]  Mark Walport,et al.  Sharing research data to improve public health , 2011, The Lancet.

[23]  P. Sandercock,et al.  The International Stroke Trial database , 2011, Trials.

[24]  Access to clinical trial data , 2011, BMJ : British Medical Journal.

[25]  Peter C Gøtzsche,et al.  Why we need easy access to all data from all clinical trials and how to accomplish it , 2011, Trials.

[26]  Catrin Tudur Smith,et al.  Assessing the consistency assumption by exploring treatment by covariate interactions in mixed treatment comparison meta‐analysis: individual patient‐level covariates versus aggregate trial‐level covariates , 2012, Statistics in medicine.

[27]  A. Sutton,et al.  Assessment of publication bias, selection bias, and unavailable data in meta-analyses using individual participant data: a database survey , 2012, BMJ : British Medical Journal.

[28]  Fiona Godlee,et al.  The new BMJ policy on sharing data from drug and device trials , 2012, BMJ : British Medical Journal.

[29]  Iain Hrynaszkiewicz,et al.  Sharing of clinical trial data among trialists: a cross sectional survey , 2012, BMJ : British Medical Journal.

[30]  Yudhijit Bhattacharjee,et al.  Biomedicine. Pharma firms push for sharing of cancer trial data. , 2012, Science.

[31]  A. Breckenridge,et al.  Open Clinical Trial Data for All? A View from Regulators , 2012, PLoS medicine.

[32]  Catrin Tudur Smith,et al.  Combining individual patient data and aggregate data in mixed treatment comparison meta‐analysis: Individual patient data may be beneficial if only for a subset of trials , 2013, Statistics in medicine.

[33]  A. Marson,et al.  Phenobarbitone versus phenytoin monotherapy for partial onset seizures and generalised onset tonic-clonic seizures. , 2013, The Cochrane database of systematic reviews.

[34]  Oxcarbazepine versus phenytoin monotherapy for epilepsy. , 2013, The Cochrane database of systematic reviews.