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A summary of the number of research proposals and enquiries that have been submitted since May 2013 is provided here. Metrics for research proposals are updated monthly and metrics for enquiries are updated every three months.

Research proposals requesting access to patient level data (number of proposals)

The table below provides metrics for different parts of the process following submission of a research proposal (Requirements check, Independent Review Panel (IRP) review, Data Sharing Agreement, Data preparation and conduct of the research project). The “In process” rows provide the number of research proposals in this part of the process. The other rows for each part of the process provide the total number of research proposals that have achieved that outcome.

Number of Research Proposals submitted up to 31 October 2017 350
Requirements check In process 25
Withdrawn by the requestor 43
Did not meet requirements (further details) 15
Potential conflict of interest or an actual or potential competitive risk 0
Met requirements 267
IRP review In process 4
Withdrawn by the requestor 6
Rejected or advised to re-submit 30
Approved or approved with conditions 227
Data Sharing Agreement In process 33
Withdrawn by the requestor 10
Not agreed by requestor 1
Agreed (signed)
View details of these research proposals
183
Data preparation In process 14
Withdrawn by the requestor 4
Complete (data available) 165
Data Access Access provided 102
Withdrawn by the requestor 3
Access closed 60
Publication Publication milestone not yet reached 46
Published or Summary received
View details of these research proposals
15
Publication or Summary not received after 18 months of Access Closed 0

Multi-sponsor research proposals were possible starting 1 January 2014. Out of 328 proposals submitted since 1 January 2014, 55 were multi-sponsor proposals.

Enquiries related to non-listed studies received via ClinicalStudyDataRequest.com

The table below provides information on the number of non-listed studies for which enquiries were received via ClinicalStudyDataRequest.com. Enquiries received outside the system and general enquiries that are not related to accessing patient level data are not included in these metrics. Enquiries related to access to documents-only are also not included in these metrics.

Submitted up to 30 September 2017

Study sponsor Number of non-listed studies requested Number of studies undergoing feasibility assessments Number of Studies with a positive response1 Number of Studies with a negative response2
Astellas 40 0 8 32 (further details)
Boehringer Ingelheim 73 1 41 31 (further details)
Daiichi Sankyo 2 1 0 2 (further details)
Eisai 53 0 2 51 (further details)
GSK 176 2 140 34 (further details)
Lilly 128 0 53 75 (further details)
Novartis 253 11 69 173 (further details)
Roche1 119 25 28 66 (further details)
Sanofi 74 2 20 52 (further details)
Takeda 14 0 1 13 (further details)
UCB 17 0 10 7 (further details)
ViiV Healthcare 3 0 3 0

1 Study to be listed on ClinicalStudyDataRequest.com and researcher able to submit a research proposal, or access to the requested data is otherwise enabled.

2 Study will not be listed on ClinicalStudyDataRequest.com / access to data cannot be provided.