TY  - JOUR
PY  - 2003//
TI  - How can we improve the assessment of safety in child and adolescent psychopharmacology?
JO  - Journal of the American Academy of Child and Adolescent Psychiatry
A1  - Vitiello, Benedetto
A1  - Riddle, Mark A.
A1  - Greenhill, Laurence L.
A1  - March, John S.
A1  - Levine, Jerome
A1  - Schachar, Russell J.
A1  - Abikoff, Howard B.
A1  - Zito, Julie M.
A1  - McCracken, James T.
A1  - Walkup, John T.
A1  - Findling, Robert L.
A1  - Robinson, James
A1  - Cooper, Thomas B.
A1  - Davies, Mark
A1  - Varipatis, Elena
A1  - Labellarte, Michael J.
A1  - Scahill, Lawrence
A1  - Capasso, Lisa
SP  - 634
EP  - 641
VL  - 42
IS  - 6
N2  - 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. CONCLUSION: 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.<p /> <p>Language: en</p>
LA  - en
SN  - 0890-8567
UR  - http://dx.doi.org/10.1097/01.CHI.0000046840.90931.36
ID  - ref1
ER  -