1. Providing Access To Patient Level Clinical Trial Data

2. The Clinical Study Data Request System
In Jan 2014, a new multi-sponsor request site launched:
Three components:
Multi-sponsor request site
Independent
review panel
Secure access system
Managed by The
Wellcome Trust

3. Participating companies
Providing Access To Patient Level Clinical Trial Data (May 2016)

4. How it works for the researcher
Select studies that are needed for the research
Submit a research proposal
Review of proposal by independent review panel
Agree: where approved, a data sharing agreement is signed
Access data in secure access system
Register research, conduct and publish
Requests for data from multiple sponsors require one proposal, one review and one set of communications.

5. GSK average cycle times for patient level data sharing requests
Based on 2016 figures (n=24)
Submission to Access Provided
4 months, excluding DSA negotiation 2
Proposal Submitted
IRP
Review
IRP
Decision
DSA
Sent
Fully Executed
DSA
Data Access
Provided
4 weeks 1
~ 8 weeks
1 week
4 weeks
Access Provided to Publication
Data Access
Provided
Data Access
Closed 3
Publication
18 months after Data Access closed
12 months
1 - Includes time to acquire more information from researchers
2 - DSA negotiations can vary, average is 3.5 months
3 - Extension can be requested for another 6-12 months

6. Metrics (through March 2017) and Costs
Total metrics for all sponsors:
Research Proposals = 305 [Still in process (25); Withdrawn (41); Did not meet requirements ( of these were not seeking access to anonymised individual level trial data); sponsor declined as potential conflict of interest or competitive risk (1)]
Independent Panel Review = 224 [Rejected or advised to re-submit (23 - design and goal of research unclear; publication plan unclear or insufficient; or qualified statistician not identified); In process (4); Withdrawn (6)]
IRP Approved or Approved with conditions = 191 [Agreement or data prep in process (31); Withdrawn (12); Agreement declined by requester (1)]
Access Provided = 147 [Access active (94); Access closed (50); Withdrawn (3)]
Publication = 7 [Publication timeline not yet reached (43)]
GSK Costs
Annual licence costs for systems ~ £300K
IRP payments £650/proposal
Internal dedicated resource ~ 20 FTE to address historical studies; ~ 5 FTE for steady- state
Notes:
The difference between number of proposals submitted (152) and the number that met requirements (118) is due to:
Submitted 152
Requirements check in process: 5
Withdrawn by the requestor: 19
Did not meet requirements: 10 E.g. Not seeking access to anonymised trial data
Potential conflict of interest or an actual or potential competitive risk: 0
Met requirements: 118

7. Future – How to Share, not Whether to Share
More participants welcome, industry and academia
Improved user-friendliness (consistent data standards, simpler access systems, maintain security but improve flexibility on how security is achieved)
Minimize proliferation of different access systems
Navigate transition to new privacy standards
Increase awareness of data availability
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