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How Can We Improve the Assessment of Safety in Child and Adolescent Psychopharmacology?

2003; Elsevier BV; Volume: 42; Issue: 6 Linguagem: Inglês

10.1097/01.chi.0000046840.90931.36

1527-5418

Benedetto Vitiello, Mark A. Riddle, JOHN T. WALKUP, Michael J. Labellarte, ELENA VARIPATIS, Laurence L. Greenhill, Mark Davies, Lisa Capasso, John S. March, Jerome Levine, James Robinson, Thomas B. Cooper, Russell Schachar, Howard Abikoff, Julie M. Zito, James T. McCracken, Robert L. Findling, Lawrence David Scahill,

Cardiac electrophysiology and arrhythmias

Objective To identify approaches to improving methods for assessing tolerability and safety of psychotropic medications in children and adolescents. Method Strengths and limitations of current methodology were reviewed and possible alternatives examined. Results Research on the validity of safety evaluation has been extremely limited. No evidence-based "gold standard" exists. Clinical trials remain the best design to establish causality, but sample size limitations prevent the detection of infrequent, though serious, adverse events. Other designs, such as cohort and case-control studies, and approaches, such as mining of large databases, must be considered. Conclusions The current lack of methodological standardization across studies prevents generalizations and meta-analyses. Because the issues relevant to drug safety are diverse, a variety of methodological approaches and instruments are needed. It is, however, possible to adopt standard basic definitions of adverse events, degree of severity, ascertainment methods, and recording procedures, as a common "core," to which more specific assessment instruments can be added. Systematic empirical testing and validation of safety methodology is needed.