Review by Joseph Ross – 08/28/2020 – 11:41am

Data Request Number: 2020-4410 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):

Useful and well described proposal to develop predictive models of therapeutic and adverse effect outcomes in patients using abiraterone acetate to treat prostate cancer. Investigators request use of 6 trials, but explain that the project will be completed on Vivli research platform. If only J&J data are being used for this project, and only the 6 J&J trials are named, the project should be conducted through our associated secure, cloud-based research platform. If the investigators are merging other data into the project, which is why they are using Vivli, those additional data should be pre-specified in the research proposal.

Recommendation for this data request: Approve