TY - JOUR
T1 - Developing methodologies for monitoring long-term safety of psychotropic medications in children
T2 - Report on the NIMH Conference, September 25, 2000
AU - Greenhill, Laurence L.
AU - Vitiello, Benedetto
AU - Abikoff, Howard
AU - Levine, Jerome
AU - March, John S.
AU - Riddle, Mark A.
AU - Capasso, Lisa
AU - Cooper, Thomas B.
AU - Davies, Mark
AU - Fisher, Prudence
AU - Findling, Robert L.
AU - Fried, Jane
AU - Labellarte, Michael J.
AU - McCracken, James T.
AU - Mcmahon, Don
AU - Robinson, James
AU - Skrobala, Anne
AU - Scahill, Lawrence
AU - Varipatis, Elena
AU - Walkup, John T.
AU - Zito, Julie M.
N1 - Funding Information:
Funding for this work was provided in part through contracts with the NIMH to the Research Foundation for Mental Hygiene (N01MH60005; Principal Investigator: Laurence Greenhill, M.D.) and with the NIMH to Johns Hopkins University (N01MH60016; Principal Investigator: Mark Riddle, M.D.). The authors acknowledge (1) the collaboration of the following members the pharmaceutical industry who joined this conference: Dawn Campbell, Pharm.D. (Noven Pharmaceuticals), Anthony S. dePadova, M.D. (Noven Pharmaceuticals), John Heiligenstein, M.D. (Eli Lilly), Alex Michaels, M.D. (Shire Pharmaceuticals), Sam Saks, M.D. (CEO, Alza Pharmaceuticals), and Edward Schnippers, M.D. (Alza Pharmaceuticals); (2) the contribution of the following members of the FDA: Roberta Glass, M.D., Cindy Kortepeter, M.D., Thomas Laughren, M.D., and Andrew D. Mosholder, M.D.; and (3) the contribution of the following members of the NIMH: Margaret Roper, Ph.D., Louise Ritz, Ph.D., and David Shore, M.D.
PY - 2003/6
Y1 - 2003/6
N2 - Objective: To improve the methods for long-term assessment of drug-associated side effects and advance knowledge of the safety profile of psychotropic medications in children and adolescents. Method: A multidisciplinary, interactive workshop was hosted by the National Institute of Mental Health (NIMH) and the Research Units on Pediatric Psychopharmacology network. Participants were experts in child and adolescent psychiatry, psychopharmacology, pharmacoepidemiology, and statistics from academia, the pharmaceutical industry, the Food and Drug Administration (FDA), and the NIMH. Evaluation of drug safety was examined from five perspectives: research design and methods, industry, regulatory requirements, bioethics, and practice settings. For each of these areas, special emphasis was placed on identifying barriers and generating solutions. Results: A major obstacle is the lack of standardization of the methods used for collecting safety data. The limitations of both randomized clinical trials and passive postmarketing surveillance in assessing long-term safety were recognized. The need to consider alternative approaches, such as registries and trend analysis of population-based databases, was highlighted. Recommendations were proposed together with possible approaches to implementation. Conclusions: A concerted effort by academic researchers, industry, FDA, practitioners, and NIMH is needed to standardize methods and lay the foundations for systematic research on the long-term safety of psychotropic medications in children.
AB - Objective: To improve the methods for long-term assessment of drug-associated side effects and advance knowledge of the safety profile of psychotropic medications in children and adolescents. Method: A multidisciplinary, interactive workshop was hosted by the National Institute of Mental Health (NIMH) and the Research Units on Pediatric Psychopharmacology network. Participants were experts in child and adolescent psychiatry, psychopharmacology, pharmacoepidemiology, and statistics from academia, the pharmaceutical industry, the Food and Drug Administration (FDA), and the NIMH. Evaluation of drug safety was examined from five perspectives: research design and methods, industry, regulatory requirements, bioethics, and practice settings. For each of these areas, special emphasis was placed on identifying barriers and generating solutions. Results: A major obstacle is the lack of standardization of the methods used for collecting safety data. The limitations of both randomized clinical trials and passive postmarketing surveillance in assessing long-term safety were recognized. The need to consider alternative approaches, such as registries and trend analysis of population-based databases, was highlighted. Recommendations were proposed together with possible approaches to implementation. Conclusions: A concerted effort by academic researchers, industry, FDA, practitioners, and NIMH is needed to standardize methods and lay the foundations for systematic research on the long-term safety of psychotropic medications in children.
KW - Adverse events
KW - Children
KW - Drug safety
KW - Psychopharmacology
KW - Treatment
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U2 - 10.1097/01.CHI.0000046842.56865.EC
DO - 10.1097/01.CHI.0000046842.56865.EC
M3 - Article
C2 - 12921472
AN - SCOPUS:0642281436
SN - 0890-8567
VL - 42
SP - 651
EP - 655
JO - Journal of the American Academy of Child and Adolescent Psychiatry
JF - Journal of the American Academy of Child and Adolescent Psychiatry
IS - 6
ER -