Review by Richard Lehman – 08/30/2016 – 1:00pm

Data Request Number: 2016-1038 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?: Unsure, further clarification from requestor is needed 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):

The dissemination plan is vague and there are no references.
I think we need further detail on the number of other pediatric epilepsy trials being sought and the details of the proposed meta-analytic methods. Do the investigators have any experience of this kind of approach? It is important that they cite similar studies, and commit themselves to full publication of their methods and their eventual findings in a peer-reviewed journal.
If their approach is wholly novel then perhaps it should be set out for comment in a journal such as Trials or PLOS One, prior to the work being done.

Recommendation for this data request: Not Approve

see comments above.