Abstract
Global regulatory initiatives have increased the number of pediatric psychopharmacology trials. Challenges in ensuring valid and reliable data in such trials include developmental limitations in symptom description, the need to combine and calibrate information from varied sources, including patients and parents/caregivers, and a dearth of pediatric-specific scales. Pediatric schizophrenia trials, with few exceptions, have used for primary efficacy assessment the (adult) Positive and Negative Syndrome Scale (PANSS), a complex and lengthy 30-item measure that has been shown to pose ratings challenges even in the adult populations for whom it was designed.
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