Metrics

Metrics

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, Data Access and Publication). 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 March 2018 393
Requirements check In process 33
Withdrawn by the requestor 42
No response received 5
Did not meet requirements (further details) 16
Potential conflict of interest or an actual or potential competitive risk 0
Met requirements 297
IRP review In process 12
Withdrawn by the requestor 4
No response received 2
Rejected or advised to re-submit 36
Approved or approved with conditions 243
Data Sharing Agreement In process 33
Withdrawn by the requestor 8
No response received 3
Not agreed by requestor 1
Agreed (signed) View details of these Research Proposals 198
Data preparation In process 9
Withdrawn by the requestor 1
No response received 2
Complete (data available) 186
Data Access Access provided 109
Withdrawn by the requestor 4
Access closed 73
Publication
Publication anticipated 34
Published
View details of these Research Proposals
21
Publication not received after 18 months of Access Closed 19

Multi-Sponsor Research Proposals were possible starting 1 January 2014. Out of 371 proposals submitted since 1 January 2014, 62 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, general Enquiries not related to accessing patient level data, Enquiries requesting access to documents only and Enquiries for specific data points are not included in these metrics.

Submitted up to 31 March 2018

Study Sponsor/Funder 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 74 0 43 31 (further details)
Daiichi Sankyo 2 1 0 2 (further details)
Eisai 67 0 6 61 (further details)
GSK 206 2 163 41 (further details)
Lilly 151 0 60 91 (further details)
Novartis 253 11 69 173 (further details)
Roche1 121 26 28 67 (further details)
Sanofi 91 2 23 66 (further details)
Takeda 14 0 1 13 (further details)
UCB 17 0 10 7 (further details)
ViiV Healthcare 5 0 5 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.