A Review of Methods for Monitoring Adverse Events in Pediatric Psychopharmacology Clinical Trials

Margaret Coates, Marina Spanos, Pooja Parmar, Tara Chandrasekhar () and Linmarie Sikich
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Margaret Coates: Duke University School of Medicine
Marina Spanos: Duke University School of Medicine
Pooja Parmar: Duke University School of Medicine
Tara Chandrasekhar: Duke University School of Medicine
Linmarie Sikich: Duke University School of Medicine

Drug Safety, 2018, vol. 41, issue 5, No 3, 465-471

Abstract: Abstract 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.

Date: 2018
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DOI: 10.1007/s40264-017-0633-z

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