A Review of Methods for Monitoring Adverse Events in Pediatric Psychopharmacology Clinical Trials
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Pediatric psychotropic prescription rates are rising, emphasizing the need for careful monitoring of drug safety in this population. Currently, no standardized assessments are used in clinical trials for adverse event (AE) elicitation focused on long-term drug treatment in pediatric patients. Despite a lack of standardized AE elicitation methods in psychiatric clinical trials, it is clear that psychiatric medications have developmentally dependent AEs that differ from those observed in adults. In this review, we discuss the use of general inquiry elicitation, drug-specific checklists, and systematic elicitation scales for AE reporting in pediatric psychopharmacology trials. The checklists evaluated include the Barkley Side Effect Rating Scales (SERS), the Pittsburg side effect rating scale, and the Systematic Monitoring of Adverse events Related to TreatmentS (SMARTS) checklist. The systematic assessment scales discussed include the Systematic Assessment for Treatment of Emergent Events (SAFTEE) and the Safety Monitoring Uniform Report Form (SMURF). We review the advantages and disadvantages of each method and discuss the need for optimal assessment of AEs. AE instruments that are created and utilized for pediatric psychiatric trials must begin to incorporate symptoms that are relevant to this population and account for the nature of the disorders to better characterize treatment-emergent AEs and monitor long-term safety.
Published Version (Please cite this version)10.1007/s40264-017-0633-z
Publication InfoCoates, Margaret; Spanos, Marina; Parmar, Pooja; Chandrasekhar, Tara; & Sikich, Linmarie (2018). A Review of Methods for Monitoring Adverse Events in Pediatric Psychopharmacology Clinical Trials. Drug Safety. 10.1007/s40264-017-0633-z. Retrieved from https://hdl.handle.net/10161/15970.
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Assistant Professor of Psychiatry and Behavioral Sciences
Psychiatrist at the Duke Center for Autism and Brain Development.Staff psychiatrist at Duke Counseling and Psychological Services.