•Unblinded searches
–One sponsor acknowledged conducting some of searching
and selection of cases with
knowledge of treatment assignment
•Exclusion of “non-treatment emergent” events
–Some sponsors excluded cases for not being “treatment emergent,” but without sufficient details to evaluate
the cases
•Discrepancies in signals of suicidality
–For one program, discrepancy seen in strength of signal emerging from re-examination of pediatric supplement
(strong signal) compared to only
the weak signal based on the sponsor’s analysis in response to 7-22-03 request (thus raising
concerns about the case finding
approach)