Abstract | BACKGROUND: 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.
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Authors | Florence T Bourgeois, Jeong Min Kim, Kenneth D Mandl |
Journal | PloS one
(PLoS One)
Vol. 9
Issue 7
Pg. e102249
( 2014)
ISSN: 1932-6203 [Electronic] United States |
PMID | 25007171
(Publication Type: Journal Article, Research Support, N.I.H., Extramural)
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Chemical References |
- Central Nervous System Stimulants
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Topics |
- Adolescent
- Attention Deficit Disorder with Hyperactivity
(drug therapy)
- Central Nervous System Stimulants
(adverse effects, therapeutic use)
- Child
- Clinical Trials as Topic
- Drug Approval
(methods, organization & administration)
- Humans
- Marketing
- Sample Size
- United States
- United States Food and Drug Administration
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