Review by Joseph Ross – 12/19/2019 – 11:10am

Data Request Number: 2019-4093 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?: Yes, or it’s highly likely Please use this space to provide any comments, feedback or concerns (optional):

Proposed study to examine CV event risk associated with GLP-1RAs and SGLT-2i, to determine if these therapies reduce the incidence of heart disease in women with type 2 diabetes. It appears that this request is not for IPD, but simply for the absolute rates from the CANVAS trial. Might the CSR be sufficient? This estimate will then be aggregated with others ascertained from the medical literature.

Recommendation for this data request: Approve