Metrics last updated January 29, 2021.
206
Data Requests Received
56
Requests Requiring Scientific Revision Prior to Approval
7
Median Number of Days for YODA Project Review [IQR, 3 - 10]
94.7%
Requests for IPD and supporting documentation
4.3%
Requests for full CSR only
Data Request Decision
87.4%Approved [n=180]1.9%Under Review/Revisions Requested [n=4]10.2%Withdrawn/Closed [n=21]0.5%Not Approved [n=1]
Number of Trials Requested
26.2%Requests for 1 trial34.5%Requests for 2-4 trials28.2%Requests for 5-19 trials11.2%Requests for 20+ trials
57.9%
Multiple trials: Same product
32.9%
Multiple trials: Different products in same disease category
9.2%
Multiple trials: Different products in different disease categories