Metrics last updated August 1, 2022.
288
Data Requests Received
75
Requests Requiring Scientific Revision Prior to Approval
7.00
Median Number of Days for YODA Project Review [IQR, 2 - 12.5]
93.8%
Requests for IPD and supporting documentation
6.3%
Requests for full CSR only
Data Request Decision
95.5%Approved [n=275]0.7%Under Review / Revisions Requested [n=2]3.1%Revisions not Received / Closed prior to Decision [n=9]0.3%Not Approved [n=1]
Number of Trials Requested
25.0%Requests for 1 trial36.1%Requests for 2-4 trials29.5%Requests for 5-19 trials9.4%Requests for 20+ trials
58.3%
Multiple trials: Same product
31.0%
Multiple trials: Different products in same disease category
10.6%
Multiple trials: Different products in different disease categories