The effects of industry sponsorship on comparator selection in trial registrations for neuropsychiatric conditions in children.
The effects of industry sponsorship on comparator selection in trial registrations for neuropsychiatric conditions in children.
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DOI：
10.1371/journal.pone.0084951
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发表时间：
2013
期刊：
影响因子：
3.7
通讯作者：
Bourgeois FT
中科院分区：
文献类型：
--
作者：
Dunn AG;Mandl KD;Coiera E;Bourgeois FT
尽管儿童药物治疗，特别是精神药物的使用越来越多，但儿童人群在临床药物试验中仍然没有得到充分研究。与药物干预的临床选择最相关的是直接比较药物与其他药物的试验。其目的是测量儿童神经精神药物试验中活性药物对照药物的患病率，并确定资金来源对对照药物选择的影响。我们分析了2006年1月至2012年5月注册的临床试验中的药物选择和药物比较。已完成的和正在进行的干预性试验，检查治疗六个神经精神疾病的儿童。使用试验研究组的信息构建每种情况的药物比较网络。在421项合格的试验注册中，228项（63，699名参与者）是针对ADHD（106项试验），自闭症谱系障碍（47项），单相抑郁症（16项），癫痫发作障碍（38项），偏头痛和其他头痛（15项）或精神分裂症（11项）的药物试验。只有11.0%的药物试验使用了活性药物对照，而44.7%使用了安慰剂对照，44.3%没有使用药物或安慰剂对照。即使是在已经确定了药物治疗方案的情况下，几乎所有的药物干预都与安慰剂进行了比较。主动比较在没有行业资助的试验中更常见（17% vs. 8%，p=0.04）。在研究的药物和选择的对照药物方面，行业资助的试验与非行业试验不同。对于73%（61/84）的药物和90%（19/21）的独特比较，试验完全由行业或非行业资助。我们发现，在选择对照药物时，行业和非行业存在差异，两组的活性药物对照药物均罕见。儿科研究活动的这一差距限制了临床医生治疗儿童的证据，并建议需要重新评估儿科试验的设计和资助，以优化儿科参与临床试验的信息。
Pediatric populations continue to be understudied in clinical drug trials despite the increasing use of pharmacotherapy in children, particularly with psychotropic drugs. Most pertinent to the clinical selection of drug interventions are trials directly comparing drugs against other drugs. The aim was to measure the prevalence of active drug comparators in neuropsychiatric drug trials in children and identify the effects of funding source on comparator selection. We analyzed the selection of drugs and drug comparisons in clinical trials registered between January 2006 and May 2012. Completed and ongoing interventional trials examining treatments for six neuropsychiatric conditions in children were included. Networks of drug comparisons for each condition were constructed using information about the trial study arms. Of 421 eligible trial registrations, 228 (63,699 participants) were drug trials addressing ADHD (106 trials), autism spectrum disorders (47), unipolar depression (16), seizure disorders (38), migraines and other headaches (15), or schizophrenia (11). Active drug comparators were used in only 11.0% of drug trials while 44.7% used a placebo control and 44.3% no drug or placebo comparator. Even among conditions with well-established pharmacotherapeutic options, almost all drug interventions were compared to a placebo. Active comparisons were more common among trials without industry funding (17% vs. 8%, p=0.04). Trials with industry funding differed from non-industry trials in terms of the drugs studied and the comparators selected. For 73% (61/84) of drugs and 90% (19/21) of unique comparisons, trials were funded exclusively by either industry or non-industry. We found that industry and non-industry differed when choosing comparators and active drug comparators were rare for both groups. This gap in pediatric research activity limits the evidence available to clinicians treating children and suggests a need to reassess the design and funding of pediatric trials in order to optimize the information derived from pediatric participation in clinical trials.
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