1. 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

2. 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

3. 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)

4. 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).

5. 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).

6. 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).

7. 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

8. Challenges for the data user
Time consuming
Legal input required
Restricted access to data via portals may not allow some methods of analysis

9. 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