Department of Otolaryngology-Head and Neck Surgery, School of Medicine, Boston University, Boston, Massachusetts, U.S.A.
Laryngoscope. 2020 Nov;130(11):2719-2724. doi: 10.1002/lary.28511. Epub 2020 Jan 29.
OBJECTIVES/HYPOTHESIS: Pediatric otolaryngologic conditions are highly prevalent in the United States. Although data gathered from clinical trials drive therapeutic strategies, the trends of research in pediatric otolaryngology remain unclear. The objective of this study was to characterize recent trials in pediatric otolaryngology to better understand current directions of study and to identify opportunities for future research.
Retrospective analysis.
A retrospective analysis of United States pediatric clinical trials in otolaryngology between 2001 and 2017 was conducted on ClinicalTrials.gov. Criteria for inclusion included otolaryngologic trials with at least one trial arm of participants <18 years of age, interventional design that was closed, and conducted in the United States. We assessed the information available to us on ClinicalTrials.gov to identify recent trends in pediatric otolaryngology interventional research. We used PubMed to examine publication rates and National Institutes of Health RePORTER to characterize funding patterns for these trials.
Of the 122 trials analyzed, 25% investigated treatments for rhinitis, 25% for acute otitis media, and 50% for all other conditions. Drug studies comprised 72% of all trials. Overall, 65% had their results published in a peer-reviewed journal. Industry funding accounted for 73% of financial support.
Continued focus on the development of pediatric otolaryngologic clinical trials allows an opportunity to better represent the wide spectrum of disease and therapy in the specialty. Increasing the rates of results publication and federal funding may spearhead a more balanced landscape of clinical trials and further advance the care of children with otolaryngologic disease.
NA Laryngoscope, 130:2719-2724, 2020.
目的/假设：小儿耳鼻喉科疾病在美国非常普遍。虽然临床试验中收集的数据驱动了治疗策略，但小儿耳鼻喉科研究的趋势仍不清楚。本研究的目的是描述最近小儿耳鼻喉科的临床试验，以更好地了解当前的研究方向，并确定未来研究的机会。
回顾性分析。
在 ClinicalTrials.gov 上对 2001 年至 2017 年期间进行的美国小儿耳鼻喉科临床试验进行了回顾性分析。纳入标准包括至少有一个 18 岁以下参与者的试验组的耳鼻喉科试验、采用封闭干预设计且在美国进行的试验。我们评估了 ClinicalTrials.gov 上提供的信息，以确定小儿耳鼻喉科干预研究的近期趋势。我们使用 PubMed 检查了这些试验的发表率，并使用 National Institutes of Health RePORTER 来描述它们的资助模式。
在分析的 122 项试验中，25%的试验研究了鼻炎的治疗方法，25%的试验研究了急性中耳炎，50%的试验研究了所有其他疾病。药物研究占所有试验的 72%。总体而言，65%的试验结果发表在同行评议的期刊上。工业界资助占财政支持的 73%。
继续关注小儿耳鼻喉科临床试验的发展为更好地代表该专业疾病和治疗方法的广泛范围提供了机会。提高研究结果发表率和联邦资金资助可能会推动临床试验更平衡的发展，并进一步促进儿童耳鼻喉科疾病的治疗。
无。Laryngoscope, 130:2719-2724, 2020.
