Premarket safety and efficacy studies for ADHD medications in children.
Premarket safety and efficacy studies for ADHD medications in children.
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DOI：
10.1371/journal.pone.0102249
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Mandl KD
中科院分区：
文献类型：
--
作者：
Bourgeois FT;Kim JM;Mandl KD
注意力缺陷多动障碍（ADHD）是一种慢性疾病，药物治疗是治疗的主要手段，患者可以使用各种ADHD药物。然而，目前尚不清楚ADHD药物在获得上市许可之前的长期安全性和有效性评估程度。我们的目的是量化研究的参与者数量和他们在上市前的ADHD药物试验中的暴露时间。我们确定了美国食品药品监督管理局（FDA）批准的所有ADHD药物，并提取了申办者进行的临床试验数据，并由FDA用于评估药物的临床疗效和安全性。对于每种ADHD药物，我们测量了研究的参与者总数和参与者暴露的时间，并确定了FDA对上市后试验的任何要求。共进行了32项临床试验，以批准20种ADHD药物。每种药物研究的受试者中位数为75例（IQR 0，419）。11种药物（55%）在研究<100名参与者后获得批准，14种（70%）在<300名参与者后获得批准。批准前的中位试验时间为4周（IQR 2，9），5种（38%）药物在参与者研究<4周后获得批准，10种（77%）在<6个月后获得批准。6种药物获得批准，并要求进行特定的额外上市后试验，其中2项已进行。为批准许多ADHD药物而进行的临床试验并未设计用于评估罕见的不良事件或长期安全性和有效性。虽然上市后研究可以填补一些空白，但需要更好地保证在新药批准之前或之后进行适当的试验。
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. 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. 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. 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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影响因子：
15.8
作者：
Duijnhoven, Ruben G.;Straus, Sabine M. J. M.;De Bruin, Marie L.
通讯作者：
De Bruin, Marie L.
DOI：
10.1097/chi.0b013e31819c23d0
发表时间：
2009-05
影响因子：
13.3
作者：
Molina BSG;Hinshaw SP;Swanson JM;Arnold LE;Vitiello B;Jensen PS;Epstein JN;Hoza B;Hechtman L;Abikoff HB;Elliott GR;Greenhill LL;Newcorn JH;Wells KC;Wigal T;Gibbons RD;Hur K;Houck PR;MTA Cooperative Group
通讯作者：
MTA Cooperative Group
影响因子：
15.8
作者：
Golder S;Loke YK;Bland M
通讯作者：
Bland M
影响因子：
39.2
作者：
Bourgeois FT;Murthy S;Mandl KD
通讯作者：
Mandl KD
影响因子：
5.6
作者：
Jain R;Babcock T;Burtea T;Dirks B;Adeyi B;Scheckner B;Lasser R
通讯作者：
Lasser R