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Submitted Requests to Use Johnson & Johnson Data

141 Data Requests Received
43 Requests Requiring Scientific Revison Prior to Approval
7 Median Number of Days for YODA Project Review [IQR, 3.25 - 10]
94.7% Requests for IPD and supporting documentation
5.3% Requests for full CSR only
Data Request Decision
84.4%Approved [n=119]5.7%Under Review/Revisions Requested [n=8]9.9%Withdrawn/Closed [n=14]0.0%Not Approved [n=0]
Purpose of Analysis
New Question (54.9%)
Meta-Analysis (54.9%)
Clinical Prediction, Risk Prediction (25.6%)
Validation (23.3%)
Statistical Methods (15.0%)
Clinical Trial Methods (12.8%)
Pilot/Preliminary Research (9.8%)
Comparison Group (9.8%)
Other (10.5%)
Number of Trials Requested
25.6%Requests for 1 trial33.1%Requests for 2-4 trials28.6%Requests for 5-19 trials12.8%Requests for 20+ trials
52.5% Multiple trials: Same product
34.3% Multiple trials: Different products in same disease category
13.1% Multiple trials: Different products in different disease categories
Primary Investigator Affiliations
Academia (90.1%)
Government (4.9%)
Industry (4.2%)
Other (0.7%)