Metrics last updated November 1, 2021.
244
Data Requests Received
66
Requests Requiring Scientific Revision Prior to Approval
6.0
Median Number of Days for YODA Project Review [IQR, 2 - 12]
94.3%
Requests for IPD and supporting documentation
5.7%
Requests for full CSR only
Data Request Decision
91.8%Approved [n=224]4.1%Under Review / Revisions Requested [n=10]3.7%Revisions not Received / Closed prior to Decision [n=9]0.4%Not Approved [n=1]
Number of Trials Requested
24.6%Requests for 1 trial36.1%Requests for 2-4 trials28.3%Requests for 5-19 trials11.1%Requests for 20+ trials
58.7%
Multiple trials: Same product
32.6%
Multiple trials: Different products in same disease category
8.7%
Multiple trials: Different products in different disease categories