Review by Joseph Ross – 08/31/2016 – 3:20pm

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?: Yes Can the proposed research be reasonably addressed using the requested data?: Unsure, further clarification from requestor is needed Recommendation for this data request: Not Approve

The proposal focuses on meta-analyzing control-arm data from anti-epilepsy clinical trials conducted among children, generating a placebo response-effect estimate. While this is important and will be of great use to science and future drug development efforts, more information is needed on what additional trials have been identified for inclusion in the meta-analysis, whether individual participant-level data (IPD) are available from these trials, whether this data will be uploaded to the secure data sharing platform to be analyzed along with the data made available from Janssen via the YODA Project, and if IPD are not available from other trials, whether summary-level data would suffice for meta-analysis. In addition, please pre-specify likely predictor variables of interest (sex, race, seizure disorder type, etc.).