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Metrics

CSDR Cycle Times for Research Proposals submitted in 2019 (n=105)

WT / Sponsor Checks
Mean 1.5 months
IRP Review
Mean 0.9 month
DSA Review and Sign Off *  
Mean 3 months
Data/Document Preparation
Mean 0.7 months
Median 1.2 months
Range 0-6.5 months
Median 0.9 months
Range 0-3.4 months
Median 2.2 months
Range 0-9.5 months
Median 0.5 months
Range 0-2.9 months
Submission to Data Access Provided (n=37)
Mean 5.4 months, Median 5 months, Range 2.5-13.8 months

Primary factors that affect the timelines:

  • Institution's DSA review process
  • Response to questions from IRP Secretariat
  • Sponsor review meeting schedules
  • Ongoing enquiry for studies not listed on CSDR
WT = Wellcome Trust Secretariat
DSA = Data Sharing Agreement
IRP = Independent Review Panel
* Note that DSA Review and Sign-off period can be greatly reduced if the standard DSA is accepted

Studies (Up to 1 July 2021)

The total number of studies listed on this site is 3073.

Research Proposals requesting access to patient level data (Up to 31 May 2021)

A summary of the number of Research Proposals received via this site since May 2013 is provided here and is updated monthly.

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. Metrics include previous and current Consortium Members.

Number of Research Proposals submitted up to 31 May 2021 643
Requirements check In process 14
Withdrawn by the requestor 70
No response received 44
Did not meet requirements (further details) 20
Potential conflict of interest or an actual or potential competitive risk 0
Met requirements 495
IRP review In process 2
Withdrawn by the requestor 5
No response received 4
Rejected or advised to re-submit 76
Approved or approved with conditions 408
Data Sharing Agreement In process 42
Withdrawn by the requestor 26
No response received 14
Not agreed by requestor 2
Agreed (signed) View details of these Research Proposals 324
Data preparation In process 3
Withdrawn by the requestor 2
No response received 2
Complete (data available) 317
Data Access Access provided 133
Withdrawn by the requestor 4
Access closed 180
Publication
Publication anticipated 59
Published
View details of these Research Proposal Publications (92)
84
Withdrawn by requestor 14
No response received 19
Publication not received after 18 months of Access Closed 15

Multi-Sponsor Research Proposals were possible starting 1 January 2014. Out of 621 proposals submitted since 1 January 2014, 92 were multi-Sponsor proposals.

Enquiries related to non-listed studies (up to 31 March 2021)

A summary of the number of Enquiries received via this site since May 2013 is provided here and is updated every 3 months.

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.

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 97 12 9 76 (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 302 0 216 86 (further details)
Lilly 205 0 92 113 (further details)
Novartis 398 1 137 260 (further details)
Roche1 217 16 53 148 (further details)
Sanofi 153 3 37 112 (further details)
Takeda 100 0 23 77 (further details)
UCB 41 0 28 13 (further details)
ViiV Healthcare 9 0 8 1 (further details)

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.