title: Safety methodology in pediatric psychopharmacology trials.
abstract: In recent years, there has been an increase in pediatric clinical trials as the result of an identified need for greater research with this population. Given the potential risks, and the vulnerability of the population, there has also been an identified need for greater safety elicitation and monitoring in pediatric psychopharmacology trials, for example, through the use of a data and safety monitoring board (DSMB). However, research indicates that pediatric trials and psychiatric trials are less likely to use a DSMB. The rationale for the current study was to determine what safety methodologies have been reported in pediatric psychopharmacology trials over the past 10 years. A literature review was conducted of all pediatric psychopharmacology trials published since 2001. Results indicated that the most common elicitation method was collecting laboratory information and vital signs. Six percent of trials solely relied on spontaneous reporting of adverse events, and only 11.8% reported using a DSMB. These results suggest that elicitation methods and use of DSMBs are still low. Practical considerations, affected stakeholders, and barriers are discussed. Recommendations for moving forward include the use of multiple elicitation methods and automatic requirement of a DSMB for pediatric psychopharmacology trials, required completion of a standardized safety reporting form, and engaging multiple interested parties in these processes.
authors.affiliation: Faculty of Health Professions, Dalhousie University, Halifax, Nova Scotia, Canada.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Yuill
authors.forename: Carlo
authors.initials: C
authors.lastname: Carandang
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy*; D061214:Patient Safety / Q000592:standards; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D011619:Psychotropic Drugs