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.