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

dc.contributor.author Coates, M
dc.contributor.author Spanos, M
dc.contributor.author Parmar, P
dc.contributor.author Chandrasekhar, T
dc.contributor.author Sikich, L
dc.coverage.spatial USA
dc.date.accessioned 2018-01-10T16:14:02Z
dc.date.available 2018-01-10T16:14:02Z
dc.date.issued 2018-01-09
dc.identifier https://doi.org/10.1007/s40264-017-0633-z
dc.identifier.issn 0114-5916
dc.identifier.uri https://hdl.handle.net/10161/15970
dc.description.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.
dc.language English
dc.publisher Springer Verlag
dc.relation.ispartof Drug Safety
dc.relation.isversionof 10.1007/s40264-017-0633-z
dc.subject Adverse events
dc.subject Psychiatric clinical trials
dc.title A Review of Methods for Monitoring Adverse Events in Pediatric Psychopharmacology Clinical Trials
dc.type Journal article
pubs.author-url https://doi.org/10.1007/s40264-017-0633-z
pubs.organisational-group Clinical Science Departments
pubs.organisational-group Duke
pubs.organisational-group Psychiatry, Child & Family Mental Health and Developmental Neuroscience
pubs.organisational-group Psychiatry & Behavioral Sciences
pubs.organisational-group School of Medicine
pubs.organisational-group Temp group - logins allowed
pubs.publication-status Published online
pubs.publisher-url https://link.springer.com/epdf/10.1007/s40264-017-0633-z?author_access_token=wTnhWHzX_wnq5yeZVu9wKve4RwlQNchNByi7wbcMAY5JLbheVO_OtYhS-BoHdjAApSl9gXbeER9rVyBORB56k4OguWaAGgZnE9-iLzMrOqoXD9uxTN1BrXZv13C0FCNOUcU6e4nMmCv7mIcBfmSVgw==
dc.identifier.eissn 1179-1942


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