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首页> 外文期刊>Pediatric drugs >Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries
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Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries

机译：2006年至2015年韩国在韩国进行的儿科临床试验：韩国临床研究信息服务，美国临床节和欧洲临床试验注册表分析

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Abstract Background The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. Objective The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. Methods We searched for pediatric clinical studies (participants Results We identified 342 clinical studies registered in the CRIS ( n ?=?81), ClinicalTrials.gov ( n ?=?225), and EuCTR ( n ?=?36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. Conclusions Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.
机译：摘要在过去十年中，韩国在韩国进行的儿科临床试验的现状，包括尚未审查具有未经批准的儿童患者的药物的临床试验。目标是提供有关当前儿科临床试验状态的信息，并通过审查三个临床试验登记数据库来为未来的审判进行依据。方法我们搜索了儿科临床研究（参与者结果，我们鉴定了在CRIS中注册的342项临床研究（n？=？81），Clinicaltrials.gov（n？=Δ225），以及哪个（n？=？36） 306在不包括重复的注册后进行审查。其中，181项研究是处理药物和生物药物的介入试验，其中129例（71.3％）涉及未经批准的药物。在这129项试验中，MFDS授权107名（82.9％）。结论韩国的儿科临床试验旨在建立儿童药物的安全性和疗效增加;但是，非MFDS授权的研究仍然是一个问题。

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  • 来源
    《Pediatric drugs》 |2017年第6期|共7页
  • 作者

    Sheung-Nyoung Choi; Ji-Hyun Lee; In-Kyung Song; Eun-Hee Kim; Jin-Tae Kim; Hee-Soo Kim;

  • 作者单位

    Department of Anesthesiology and Pain Medicine Seoul National University College of Medicine;

    Department of Anesthesiology and Pain Medicine Seoul National University College of Medicine;

    Department of Anesthesiology and Pain Medicine Seoul National University College of Medicine;

    Department of Anesthesiology and Pain Medicine Seoul National University College of Medicine;

    Department of Anesthesiology and Pain Medicine Seoul National University College of Medicine;

    Department of Anesthesiology and Pain Medicine Seoul National University College of Medicine;

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  • 正文语种 eng
  • 中图分类 药学;
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