Analysis of the distribution of trial sites in South Korea using social network analysis.

IF 1.1 Q4 PHARMACOLOGY & PHARMACY Translational and Clinical Pharmacology Pub Date : 2023-03-01 DOI:10.12793/tcp.2023.31.e2
Ki Young Huh, Kyung-Sang Yu, Ildae Song
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Abstract

Location of trial sites can be a potential source of study bias. Considering that clinical trials have been mostly conducted in urban areas, the distribution of trial sites need to be evaluated. We analyzed clinical trial approval data using social network analysis to quantitatively assess the site-by-site connections. The approval list of clinical trials from the Ministry of Food and Drug Safety database between 2014 and 2021 was analyzed. The number of clinical trials per trial site was counted according to the approval year and study phase and evaluated for distribution using empirical cumulative distribution function plots. Trial sites and conducts of a clinical trial were mapped into nodes and edges in the social network analysis, and basic network parameters were obtained. The clinical trials were concentrated at several trial sites. Forty-nine to 60.6% of phase 1 and up to 30% of the other study phases of clinical trials were at the top 5 trial sites. The annual distribution of the number of clinical trials per site was comparable across the study period. Connections among the trial sites in the metropolitan area were prominent. Graph size and density were higher in phase 3 trials than in the other phases. We demonstrated that the conduct of clinical trials was concentrated in the Seoul Metropolitan Area in both number of trials and connections using social network analysis.

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利用社会网络分析法分析韩国试验点的分布。
试验地点的位置可能是研究偏倚的潜在来源。考虑到临床试验大多在城市地区进行,需要对试验地点的分布进行评估。我们使用社会网络分析分析临床试验批准数据,定量评估每个站点的连接。分析2014 - 2021年食品药品安全部数据库中临床试验审批清单。按批准年份和研究阶段统计每个试验点的临床试验数量,并采用经验累积分布函数图进行分布评价。在社会网络分析中,将临床试验的试验地点和行为映射为节点和边缘,获得基本网络参数。临床试验集中在几个试验点。49 - 60.6%的第一阶段临床试验和高达30%的其他阶段临床试验在前5个试验地点进行。在整个研究期间,每个地点的临床试验数量的年度分布具有可比性。首都圈各试验点之间的联系明显。图的大小和密度在第三阶段的试验比在其他阶段更高。我们利用社会网络分析证明了临床试验的进行在试验数量和联系上都集中在首都地区。
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来源期刊
Translational and Clinical Pharmacology
Translational and Clinical Pharmacology Medicine-Pharmacology (medical)
CiteScore
1.60
自引率
11.10%
发文量
17
期刊介绍: Translational and Clinical Pharmacology (Transl Clin Pharmacol, TCP) is the official journal of the Korean Society for Clinical Pharmacology and Therapeutics (KSCPT). TCP is an interdisciplinary journal devoted to the dissemination of knowledge relating to all aspects of translational and clinical pharmacology. The categories for publication include pharmacokinetics (PK) and drug disposition, drug metabolism, pharmacodynamics (PD), clinical trials and design issues, pharmacogenomics and pharmacogenetics, pharmacometrics, pharmacoepidemiology, pharmacovigilence, and human pharmacology. Studies involving animal models, pharmacological characterization, and clinical trials are appropriate for consideration.
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