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ICTMC Conference 2017, ACC Liverpool, 9th May 2017
Sharing individual participant data from clinical trials: Current practice and future thinking Data User Perspective Sarah Nevitt Department of Biostatistics University of Liverpool Acknowledgements: Professor Catrin Tudur Smith, Professor Tony Marson
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Cochrane review: Antiepileptic drug monotherapy for epilepsy: a network meta-analysis of individual participant data Ten Antiepileptic Drugs Carbamazepine (CBZ) Phenobarbitone (PHB) Oxcarbazepine (OXC) Phenytoin (PHT) Valproate (VPA) Lamotrigine (LTG) Gabapentin (GBP) Topiramate (TPM) Levetiracatam (LEV) Zonisamide (ZNS) 45 pairwise comparisons 77 trials 18045 participants Describe this
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Data requesting: then and now
Type of trial Requests : Requests : Requested Provided Academic 15 trials 6 trials (40%) 27 trials 7 trials (26%) 1803 participants 1008 participants (56%) 2178 participants 801 participants (37%) Government 4 trials 3 trials (75%) 1 trial 0 trials (0%) 1178 participants 1091 participants (93%) 593 participants 0 participants (0%) Pharmaceutical 11 trials 9 trials (81%) 17 trials 8 trials (47%) 2906 participants 2604 participants (90%) 6950 participants 4534 participants (65%) Total 30 trials 18 trials (60%) 45 trials 15 trials (33%) 5887 participants 4703 participants (80%) 9721 participants 5335 participants (55%) Plus IPD from two trials conducted at our own CTRC (2437 participants)
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Data requesting: then and now
Type of trial Requests : Requests : Requested Provided Academic 15 trials 6 trials (40%) 27 trials 7 trials (26%) 1803 participants 1008 participants (56%) 2178 participants 801 participants (37%) Government 4 trials 3 trials (75%) 1 trial 0 trials (0%) 1178 participants 1091 participants (93%) 593 participants 0 participants (0%) Pharmaceutical 11 trials 9 trials (81%) 17 trials 8 trials (47%) 2906 participants 2604 participants (90%) 6950 participants 4534 participants (65%) Total 30 trials 18 trials (60%) 45 trials 15 trials (33%) 5887 participants 4703 participants (80%) 9721 participants 5335 participants (55%) Final total: out of a total of eligible participants (69% of total data) from 36 out of the 77 eligible trials (47% of total trials).
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Data requesting: then and now
Type of trial Requests : Requests : Requested Provided Academic 15 trials 6 trials (40%) 27 trials 7 trials (26%) 1803 participants 1008 participants (56%) 2178 participants 801 participants (37%) Government 4 trials 3 trials (75%) 1 trial 0 trials (0%) 1178 participants 1091 participants (93%) 593 participants 0 participants (0%) Pharmaceutical 11 trials 9 trials (81%) 17 trials 8 trials (47%) 2906 participants 2604 participants (90%) 6950 participants 4534 participants (65%) Total 30 trials 18 trials (60%) 45 trials 15 trials (33%) 5887 participants 4703 participants (80%) 9721 participants 5335 participants (55%) Final total: out of a total of eligible participants (69% of total data) from 36 out of the 77 eligible trials (47% of total trials).
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Data requesting: CSDR 17 requests for pharmaceutical trials
6 requests were made via CSDR – IPD provided for one trial Two trials not complete at the time of request Two trials out of scope to provide data (too old) One trial had country specific restrictions Other requests made directly to the company All of these companies have now joined CSDR (or an equivalent data sharing platform).
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Advantages for the data user
Clear and structured format for requesting data Fewer unresolved requests Clear route of communication with the data provider ‘Cleaner’ data provided Potentially wider audience for the research
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Challenges for the data user
Time consuming Legal input required Restricted access to data via portals may not allow some methods of analysis
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Data Sharing: Data user perspective
References Nevitt SJ, Sudell M, Weston J, Tudur Smith C, Marson AG. Antiepileptic drug monotherapy for epilepsy: a network meta-analysis of individual participant data. Cochrane Database of Systematic Reviews (submitted). Nevitt SJ, Marson AG, Davie B, Reynolds S, Williams L, Tudur Smith C. Exploring changes over time and characteristics associated with data retrieval across individual participant data meta-analyses: systematic review. BMJ 2017;357:j1390 Thank you for listening! Sarah Nevitt
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