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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 July 2017 333
Requirements check In process 22
Withdrawn by the requestor 41
Did not meet requirements (further details) 15
Potential conflict of interest or an actual or potential competitive risk 0
Met requirements 255
IRP review In process 7
Withdrawn by the requestor 6
Rejected or advised to re-submit 27
Approved or approved with conditions 215
Data Sharing Agreement In process 34
Withdrawn by the requestor 9
Not agreed by requestor 1
Agreed (signed)
View details of these research proposals
171
Data preparation In process 6
Withdrawn by the requestors 3
Complete (data available) 162
Data Access Access provided 104
Withdrawn by the requestor 3
Access closed 55
Publication Publication milestone not yet reached 42
Published or Summary received
View details of these research proposals
13
Publication or Summary not received after 18 months of Access Closed 0

Multi-sponsor research proposals were possible starting 1 January 2014. Out of 311 proposals submitted since 1 January 2014, 53 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 June 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 169 1 135 33 (further details)
Lilly 124 0 52 72 (further details)
Novartis 228 12 51 165 (further details)
Roche1 94 0 28 66 (further details)
Sanofi 70 8 13 49 (further details)
UCB 3 0 3 0
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.