Review by Joseph Ross – 10/25/2019 – 3:27pm

Data Request Number: 2019-3999 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):

This is an interesting proposal to examine psychiatric as adverse events among patients on abiraterone / prednisolone therapy for metastatic prostate cancer, using data from the YODA Project. However, I was not clear if the investigator was requesting access to the IPD or CSR data only. It seems to be the latter, as the investigators collect data on these AEs, which are then used for the meta-analysis. If that’s true, could the authors better clarify that point (that they are only using the CSRs)?
That said, I think the investigators will need access to the IPD in order to better identify psychiatric AEs from the adverse event terms for each trial. I would actually suggest the authors pursue this route, and pre-specify which terms will be used to represent the psychiatric AEs of interest. But perhaps I am misunderstanding the project design.

Recommendation for this data request: Not Approve

see above