在临床偏头痛试验注册中查找组织及其方法:对ClinicalTrials.gov的分析
Locating Organizations and Their Methods in Registrations of Clinical Migraine Trials: Analysis of ClinicalTrials.gov.
作者信息
Zhang Pengfei, Do Thien Phu
机构信息
Department of Neurology, Robert Wood Johnson University Hospital - New Brunswick, New Brunswick, NJ, United States.
Department of Neurology, Danish Headache Center, Faculty of Health and Medical Sciences, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.
出版信息
Front Neurol. 2021 Oct 1;12:739109. doi: 10.3389/fneur.2021.739109. eCollection 2021.
ClinicalTrials.gov is a centralized venue for monitoring clinical research and allows access to information on publicly and privately funded studies. To better recognize influential institutions in the field of headache, we identified major organizations conducting clinical trials in migraine research. Furthermore, we examined the frequency of different study designs. Utilizing the ClinicalTrials.gov application programming interface, we extracted studies including individuals with migraine from February 29, 2000, to July 28, 2020, for the following: (1) host organization, (2) study type, (3) primary purpose, (4) intervention model, and (5) allocation. We included 921 entries encompassing 423 organizations. Thirty-two organizations produced ≥5 entries each and 40.0% of all entries. Most, 86%, were interventional studies while 13.6% were observational studies. The most common study design had a randomized allocation of participants. The most frequent primary purpose was treatment (62.4%) followed by prevention (13.0%). There were 56.9% parallel assignment models, 15.2% single group assignment models, and 12.4% crossover assignment models. A minority of organizations contribute to a significant number of registrations of clinical migraine trials, suggesting that clinical research in migraine is oligarchic. The most common study is interventional and randomized, with parallel assignment of participants with treatment as the primary purpose. This likely reflects the need to evaluate novel putative pharmacological medications.
ClinicalTrials.gov是一个监测临床研究的集中平台,可提供有关公共和私人资助研究的信息。为了更好地识别头痛领域中有影响力的机构,我们确定了在偏头痛研究中开展临床试验的主要组织。此外,我们还研究了不同研究设计的频率。利用ClinicalTrials.gov应用程序编程接口,我们提取了2000年2月29日至2020年7月28日期间包括偏头痛患者的研究,内容如下:(1)主办机构,(2)研究类型,(3)主要目的,(4)干预模型,以及(5)分配方式。我们纳入了921条记录,涉及423个组织。32个组织各自产生了≥5条记录,占所有记录的40.0%。大多数(86%)是干预性研究,而观察性研究占13.6%。最常见的研究设计是对参与者进行随机分配。最常见的主要目的是治疗(62.4%),其次是预防(13.0%)。平行分配模型占56.9%,单组分配模型占15.2%,交叉分配模型占12.4%。少数组织促成了大量偏头痛临床试验的注册,这表明偏头痛的临床研究具有寡头性质。最常见的研究是干预性和随机性的,主要目的是对参与者进行平行分配治疗。这可能反映了评估新型假定药物的必要性。