Metrics last updated May 1, 2022.
278
Data Requests Received
73
Requests Requiring Scientific Revision Prior to Approval
6.0
Median Number of Days for YODA Project Review [IQR, 2 - 12.25]
93.5%
Requests for IPD and supporting documentation
6.5%
Requests for full CSR only
Data Request Decision
94.6%Approved [n=263]1.8%Under Review / Revisions Requested [n=5]3.2%Revisions not Received / Closed prior to Decision [n=9]0.4%Not Approved [n=1]
Number of Trials Requested
25.2%Requests for 1 trial36.7%Requests for 2-4 trials28.4%Requests for 5-19 trials9.7%Requests for 20+ trials
59.6%
Multiple trials: Same product
31.7%
Multiple trials: Different products in same disease category
8.7%
Multiple trials: Different products in different disease categories