Review by Richard Lehman – 02/10/2016 – 12:48pm

Data Request Number: 2016-0716 Please use this space to provide any comments, feedback or concerns (optional):

I am doubtful that the requested data will be able to address the applicant’s questions. The “mediation analysis” idea is interesting but presumes that there is sufficient differentiation within the outcome reporting at an individual participant level. My guess is that the required information about social v mental function is incomplete at best, and that therefore the mediation analysis will not reach validity. However, if the data sets are already de-identified and ready, I would not want to stand in the way of an attempt to do this. On the other hand, if processing these data would require considerable new effort & resource from J&J, I don’t think this proposal justifies it.