Metrics last updated May 1, 2023.
339
Data Requests Received
80
Requests Requiring Scientific Revision Prior to Approval
7.00
Median Number of Days for YODA Project Review [IQR, 2 - 13]
94.7%
Requests for IPD and supporting documentation
5.3%
Requests for full CSR only
Data Request Decision
95.3%Approved [n=323]1.5%Under Review / Revisions Requested [n=5]2.9%Revisions not Received / Closed prior to Decision [n=10]0.3%Not Approved [n=1]
Number of Trials Requested
25.1%Requests for 1 trial34.8%Requests for 2-4 trials31.6%Requests for 5-19 trials8.6%Requests for 20+ trials
56.9%
Multiple trials: Same product
32.7%
Multiple trials: Different products in same disease category
10.5%
Multiple trials: Different products in different disease categories