Review by Cary Gross – 07/06/2020 – 11:00am

Data Request Number: 2020-4276 Is the scientific purpose of the research proposal clearly described?: Yes Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Yes Can the proposed research be reasonably addressed using the requested data?: Unsure, further clarification from requestor is needed Please use this space to provide any comments, feedback or concerns (optional):

Given that the investigators are not requesting patient-level data and are not proposing to conduct analyses on the YODA platform, they should specify that the request is for the CSR data only. The analytic approach for the meta-analysis is lacking detail in assessment of heterogeneity and appropriateness of pooling data to provide summary estimates.

Recommendation for this data request: Not Approve

further clarification requested.