•Present Concerns:
–Optimal approaches for searching this database for events suggestive of suicidality
–Optimal approaches for rationally classifying possibly suicide-related events into categories for analysis
–Optimal approaches for planned patient level data analysis
•Future Concerns:
–Optimal approaches for ascertainment of suicidality
–Comments on largely negative efficacy results in short-term pediatric MDD trials, and possible value of randomized withdrawal design