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

Loading...
Thumbnail Image

Date

2018-01-09

Journal Title

Journal ISSN

Volume Title

Repository Usage Stats

121
views
220
downloads

Citation Stats

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.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1007/s40264-017-0633-z

Publication Info

Coates, Margaret, Marina Spanos, Pooja Parmar, T Chandrasekhar and Lin Sikich (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.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Chandrasekhar

Tara Chandrasekhar

Assistant Professor of Psychiatry and Behavioral Sciences

Duke Autism Clinic


Unless otherwise indicated, scholarly articles published by Duke faculty members are made available here with a CC-BY-NC (Creative Commons Attribution Non-Commercial) license, as enabled by the Duke Open Access Policy. If you wish to use the materials in ways not already permitted under CC-BY-NC, please consult the copyright owner. Other materials are made available here through the author’s grant of a non-exclusive license to make their work openly accessible.