Review by Joseph Ross – 07/06/2020 – 11:51am

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?: Yes, or it’s highly likely Please use this space to provide any comments, feedback or concerns (optional):

Systematic review and meta-analysis to examine the risk of psychiatric AEs associated with topiramate use. Investigators are requesting access to CSRs of 38 RCTs via the YODA Project, not IPD. From the CSR AE summaries, they will ascertain psychiatric AE counts for their meta-analysis. Results of this work will be informative to patients and clinicians alike. I would only recommend that they register their review protocol in PROSPERO, so others can know they are working on this question and provide feedback as appropriate.

Recommendation for this data request: Approve