Department of Psychiatry, University of Rochester, Rochester, NY, United States of America.
Department of Radiation Oncology, MGH, Harvard University, Boston, MA, United States of America.
PLoS One. 2021 Apr 1;16(4):e0248898. doi: 10.1371/journal.pone.0248898. eCollection 2021.
Whereas time trends in the epidemiologic burden of US pediatric mental health disorders are well described, little is known about trends in how these disorders are studied through clinical research. We identified how funding source, disorders studied, treatments studied, and trial design changed over the past decade in US pediatric mental health clinical trials. We identified all US pediatric interventional mental health trials submitted to ClinicalTrials.gov between October 1, 2007 and April 30, 2018 (n = 1,019) and manually characterized disorders and treatments studied. We assessed trial growth and design characteristics by funding source, treatments, and disorders. US pediatric mental health trials grew over the past decade (compound annual growth rate [CAGR] 4.1%). The number of studies funded by industry and US government remained unchanged, whereas studies funded by other sources (e.g., academic medical centers) grew (CAGR 11.3%). Neurodevelopmental disorders comprised the largest proportion of disorders studied, and Non-DSM-5 (Diagnostic and Statistical Manual-5) conditions was the only disorder category to grow (14.5% to 24.6%; first half to second half of decade). There was significant growth of trials studying non-psycho/pharmacotherapy treatments (33.8% to 49.0%) and a decline in trials studying pharmacotherapies (31.7% to 20.6%), though these trends differed by funding source. There were also notable differences in funding sources and treatments studied within each disorder category. Trials using double blinding declined (26.2% to 18.0%). Limitations include that ClinicalTrials.gov is not an exhaustive list of US clinical trials, and trends identified may in part reflect changes in trial registration rather than changes in clinical research. Nevertheless, ClinicalTrials.gov is among the largest databases available for evaluating trends and patterns in pediatric mental health research that might otherwise remain unassessable. Understanding these trends can guide researchers and funding bodies when considering the trajectory of the field.
尽管美国儿科心理健康障碍的流行病学负担的时间趋势已经得到很好的描述，但对于这些障碍如何通过临床研究进行研究的趋势却知之甚少。我们确定了过去十年中，美国儿科心理健康临床试验中资金来源、研究疾病、研究治疗方法和试验设计的变化。我们在美国临床试验数据库（ClinicalTrials.gov）中，确定了 2007 年 10 月 1 日至 2018 年 4 月 30 日期间提交的所有美国儿科干预性心理健康试验（n=1019），并手动描述了研究的疾病和治疗方法。我们根据资金来源、治疗方法和疾病评估了试验的增长和设计特点。在过去的十年中，美国儿科心理健康试验的数量不断增加（复合年增长率[CAGR]为 4.1%）。行业和美国政府资助的研究数量保持不变，而其他来源（如学术医疗中心）资助的研究数量有所增加（CAGR 为 11.3%）。神经发育障碍是研究最多的疾病，而非 DSM-5（诊断和统计手册-5）疾病是唯一增长的疾病类别（从第一半到第二半十年，从 14.5%增长到 24.6%）。研究非精神/药物治疗的试验数量显著增加（从 33.8%增加到 49.0%），而研究药物治疗的试验数量下降（从 31.7%下降到 20.6%），但这些趋势因资金来源而异。在每个疾病类别中，资金来源和治疗方法的研究也存在显著差异。使用双盲法的试验数量减少（从 26.2%减少到 18.0%）。研究的局限性包括 ClinicalTrials.gov 并不是美国临床试验的详尽清单，而且确定的趋势部分可能反映了试验注册的变化，而不是临床研究的变化。尽管如此，ClinicalTrials.gov 是评估儿科心理健康研究趋势和模式的最大可用数据库之一，如果没有这些数据库，这些趋势和模式可能仍然无法评估。了解这些趋势可以为研究人员和资助机构在考虑该领域的发展轨迹时提供指导。
