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dc.contributor.authorBourgeois, Florence T.en_US
dc.contributor.authorKim, Jeong Minen_US
dc.contributor.authorMandl, Kenneth D.en_US
dc.date.accessioned2014-08-13T13:58:17Z
dc.date.issued2014en_US
dc.identifier.citationBourgeois, Florence T., Jeong Min Kim, and Kenneth D. Mandl. 2014. “Premarket Safety and Efficacy Studies for ADHD Medications in Children.” PLoS ONE 9 (7): e102249. doi:10.1371/journal.pone.0102249. http://dx.doi.org/10.1371/journal.pone.0102249.en
dc.identifier.issn1932-6203en
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:12717387
dc.description.abstractBackground: Attention-deficit hyperactivity disorder (ADHD) is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing. Methods: We identified all ADHD medications approved by the Food and Drug Administration (FDA) and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug’s clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials. Results: A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419). Eleven drugs (55%) were approved after <100 participants were studied and 14 (70%) after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9), with 5 (38%) drugs approved after participants were studied <4 weeks and 10 (77%) after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed. Conclusions: Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved.en
dc.language.isoen_USen
dc.publisherPublic Library of Scienceen
dc.relation.isversionofdoi:10.1371/journal.pone.0102249en
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC4090185/pdf/en
dash.licenseLAAen_US
dc.subjectMedicine and Health Sciencesen
dc.subjectClinical Medicineen
dc.subjectClinical Trialsen
dc.subjectPediatricsen
dc.subjectPharmacologyen
dc.subjectDrug Research and Developmenten
dc.titlePremarket Safety and Efficacy Studies for ADHD Medications in Childrenen
dc.typeJournal Articleen_US
dc.description.versionVersion of Recorden
dc.relation.journalPLoS ONEen
dash.depositing.authorBourgeois, Florence T.en_US
dc.date.available2014-08-13T13:58:17Z
dc.identifier.doi10.1371/journal.pone.0102249*
dash.contributor.affiliatedBourgeois, Florence
dash.contributor.affiliatedMandl, Kenneth


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