Review by Joseph Ross – 07/14/2017 – 4:14pm

Data Request Number: 2017-1846 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):

This is an ambitious proposal to use placebo arm data from more than 30 antipsychotic drug clinical trials to better understand symptoms after therapy discontinuation. I was confused by one thing: how will the Ki values, defined as specific receptor affinities, be estimated? My understanding is that PK information is needed to calculate Ki values, which I do not expect to be available within the RCT data, but perhaps I am misunderstanding. Please clarify.

Recommendation for this data request: Approve