Metrics last updated February 1, 2023.
322
Data Requests Received
76
Requests Requiring Scientific Revision Prior to Approval
7.00
Median Number of Days for YODA Project Review [IQR, 2 - 13]
94.4%
Requests for IPD and supporting documentation
5.6%
Requests for full CSR only
Data Request Decision
95.3%Approved [n=307]1.2%Under Review / Revisions Requested [n=4]3.1%Revisions not Received / Closed prior to Decision [n=10]0.3%Not Approved [n=1]
Number of Trials Requested
25.2%Requests for 1 trial35.7%Requests for 2-4 trials30.4%Requests for 5-19 trials8.7%Requests for 20+ trials
58.1%
Multiple trials: Same product
31.8%
Multiple trials: Different products in same disease category
10.2%
Multiple trials: Different products in different disease categories