Article(id=1322181140711060449, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1621180800000, acceptedDateStr=2021-05-17, onlineDate=1793162148883, onlineDateStr=2026-10-28, pubDate=1627574400000, pubDateStr=2021-07-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793162148883, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793162148883, creator=13701087609, updateTime=1793162148883, updator=13701087609, issue=Issue{id=1322181102488375822, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='14', pageStart='1249', pageEnd='1344', issueExtLink='null', onlineDate='null', pubDate='1627574400000', pubDateStr='2021-07-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793162139770, creator='13701087609', updateTime=1793162209831, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322181396408419308, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322181396408419309, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322181102488375822, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1302, endPage=1308, ext={EN=ArticleExt(id=1322181140962718690, articleId=1322181140711060449, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Comparative study on the management of pediatric clinical trials between China and America, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

A pediatric clinical trial is a systematic study of a drug in people aged 0~18 years. Due to the specialness of the subjects, the process management of pediatric clinical trial is particularly important. Whether a high-quality pediatric clinical trial can be carried out directly affects the marketing speed of pediatric drugs, and then affects the accessibility of pediatric drugs. At present, there are still some problems in pediatric clinical trials in China, such as difficulty in recruiting subjects, lack of high-quality standard management in the trial process, and lack of rigor in the ethical review. Based on a comprehensive analysis of the policies, measures and regulatory experience in promoting the development of pediatric clinical trials in the United States, this paper compared the relevant policies and regulatory systems of pediatric clinical trials in China with those in the United States, and analyzed the problems existing in the management of pediatric clinical trials in China, so as to propose countermeasures and suggestions for improving our management of pediatric clinical trials.

, authors=Yi-ming ZHONG, Tian-yi ZHANG, Wen GUO, authorsList=Yi-ming ZHONG, Tian-yi ZHANG, Wen GUO, authorCompany=null, correspAuthors=Wen GUO, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322181141256319971, articleId=1322181140711060449, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=中美儿科临床试验管理的比较研究, columnId=1236331741447778310, journalTitle=中国新药杂志, columnName=药物临床试验规范与进展专栏, runingTitle=null, highlight=null, articleAbstract=

儿科临床试验是指在0~18岁人群中进行药物的系统性研究，儿童作为临床试验的受试者，其试验过程的管理尤为重要，能否高质量地开展儿科临床试验直接影响到儿童用药的上市速度，进而影响到儿童用药的可及性。目前，我国儿科临床试验中尚存在受试者招募困难、试验过程缺乏高质量的规范管理以及在伦理审查把关上还不够严谨等问题。基于此，本文在综合分析美国促进儿科临床试验开展的政策措施及监管经验的基础上，对比我国儿科临床试验相关政策与监管体系，分析我国在儿科临床试验管理上存在的问题，以此提出改善我国儿科临床试验管理的对策建议。

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钟一鸣，男，硕士研究生，主要从事医药信息研究。E-mail：zhongym@pharmadl.com。

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pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=null, journalName=null, refType=null, unstructuredReference=中国医药工业信息中心. 中国新药研发监测数据库(CPM)[EB/OL]. [2020-10-12]. http://cpm.pharmadl.com/., articleTitle=null, refAbstract=null), Reference(id=1322181145123468287, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=中华人民共和国国家统计局. 中国统计年鉴[M]. 北京: 中国统计出版社, 2020., articleTitle=null, refAbstract=null), Reference(id=1322181145249297408, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[3], rfOrder=2, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Clinicaltrials.gov[EB/OL]. [2020-11-04]. https://clinicaltrials.gov/., articleTitle=null, refAbstract=null), Reference(id=1322181145328988160, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[4], rfOrder=3, authorNames=null, journalName=null, refType=null, unstructuredReference=U.S. GOVERNMENT ACCOUNTABILITY OFFICE. Pediatric Drug Research: Studies Conducted under Best Pharmaceuticals for Children Act[EB/OL]. [2020-11-04]. https://www.gao.gov/assets/gao-07-557.pdf., articleTitle=null, refAbstract=null), Reference(id=1322181145467400193, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[5], rfOrder=4, authorNames=null, journalName=null, refType=null, unstructuredReference=中国医院协会病案管理专业委员会. 第二十四届学术会议论文集汇编[C]. 中国医院协会病案管理专业委员会, 2015., articleTitle=null, refAbstract=null), Reference(id=1322181145584840706, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[6], rfOrder=5, authorNames=null, journalName=null, refType=null, unstructuredReference=赵崇涛, 张立英. 我国儿童肿瘤疾病的发展状况及预防的初探[J]. 中国民康医学, 2015, 27(12): 81-83., articleTitle=null, refAbstract=null), Reference(id=1322181145664532483, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[7], rfOrder=6, authorNames=null, journalName=null, refType=null, unstructuredReference=海莉丽, 朱琳, 李智平. 药物制剂辅料在儿童群体中的安全性考量[J]. 中国药学杂志, 2019, 54(14): 1121-1125., articleTitle=null, refAbstract=null), Reference(id=1322181145744224260, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[8], rfOrder=7, authorNames=null, journalName=null, refType=null, unstructuredReference=王之羽, 石雅丽, 王敏, 等. 儿科门诊患者家庭用药管理现状分析[J]. 中国现代应用药学, 2019, 36(12): 1565-1568., articleTitle=null, refAbstract=null), Reference(id=1322181145840693253, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=8, authorNames=null, journalName=null, refType=null, unstructuredReference=李莉霞, 王晓芸, 李方, 等. 家长对儿童药物临床试验认知与态度调查[J]. 儿科药学杂志, 2019, 25(3): 43-47., articleTitle=null, refAbstract=null), Reference(id=1322181145928773638, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[10], rfOrder=9, authorNames=null, journalName=null, refType=null, unstructuredReference=IC. Regulation of drugs for children in Europe[J]. BMJ, 2007, 335(7632): 1211-1222., articleTitle=null, refAbstract=null), Reference(id=1322181146042019847, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[11], rfOrder=10, authorNames=null, journalName=null, refType=null, unstructuredReference=姜亚莉, 徐亮, 蔡萍, 等. 医院药物临床试验质量管理措施探讨[J]. 中国卫生产业, 2018, 15(6): 67-68., articleTitle=null, refAbstract=null), Reference(id=1322181146146877448, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[12], rfOrder=11, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Food And Drug Administration Modernization Act of 1997[EB/OL]. [2020-11-04]. https://www.cov.com/-/media/files/corporate/publications/1997/12/oid6193.pdf., articleTitle=null, refAbstract=null), Reference(id=1322181146243346441, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[13], rfOrder=12, authorNames=null, journalName=null, refType=null, unstructuredReference=潘家梅, 张象麟. 美国激励研制罕见儿科疾病药品的“优先审评券计划”制度概述[J]. 中国药事, 2019, 33(1): 50-55., articleTitle=null, refAbstract=null), Reference(id=1322181146348204042, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[14], rfOrder=13, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. TitleⅣ-Pediatric Research Equity Act of 2007[EB/OL]. [2020-11-04]. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM049870.pdf., articleTitle=null, refAbstract=null), Reference(id=1322181146478227467, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[15], rfOrder=14, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Food and Drug Administration Safety and Innovation Act[EB/OL]. [2020-11-04]. https://www.fda.gov/media/96077/download., articleTitle=null, refAbstract=null), Reference(id=1322181146574696460, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[16], rfOrder=15, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. TitleⅤ-Best Pharmaceuticals for Children Act of 2007[EB/OL]. [2020-11-04]. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM049870.pdf., articleTitle=null, refAbstract=null), Reference(id=1322181146830549005, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[17], rfOrder=16, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. S.830-Pediatric Medical Device Safety and Improvement Act of 2007[EB/OL]. [2020-11-04]. https://www.congress.gov/110/bills/s830/BILLS-110s830is.pdf., articleTitle=null, refAbstract=null), Reference(id=1322181146922823694, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[18], rfOrder=17, authorNames=null, journalName=null, refType=null, unstructuredReference=万征, 范玉明. 国内外药物临床试验GCP检查概述与启示[J]. 中国药事, 2018, 32(4): 423-431., articleTitle=null, refAbstract=null), Reference(id=1322181148613128207, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[19], rfOrder=18, authorNames=null, journalName=null, refType=null, unstructuredReference=高敏洁. 美国FDA对新药临床试验申办者和合同研究组织的监管模式[J]. 中国新药与临床杂志, 2016, 35(2): 109-113., articleTitle=null, refAbstract=null), Reference(id=1322181148768317456, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[20], rfOrder=19, authorNames=null, journalName=null, refType=null, unstructuredReference=刘昌孝. 国际药品监管科学发展概况[J]. 药物评价研究, 2017, 40(8): 1029-1043., articleTitle=null, refAbstract=null), Reference(id=1322181148898340881, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[21], rfOrder=20, authorNames=null, journalName=null, refType=null, unstructuredReference=王迪. FDA设立监管科学中心[EB/OL]. (2014-06-04). [2018-05-23]. http://web.yyjjh.com:8080/html/2014/06/04/content_209729.htm., articleTitle=null, refAbstract=null), Reference(id=1322181149040947218, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[22], rfOrder=21, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Centers of Excellence in Regulatory Science and Innovation (CERSI)[EB/OL]. (2018-04-09) [2020-11-04]. http://www.fda.gov/scienceresearch/specialtopics/regulatoryscienceucm301667.htm., articleTitle=null, refAbstract=null), Reference(id=1322181149137416211, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[23], rfOrder=22, authorNames=null, journalName=null, refType=null, unstructuredReference=王婧璨, 温宝书, 陈成立. 美国新药临床试验期间沟通交流机制简介与思考[J]. 中国新药杂志, 2020, 29(11): 1222-1226., articleTitle=null, refAbstract=null), Reference(id=1322181149221302292, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[24], rfOrder=23, authorNames=null, journalName=null, refType=null, unstructuredReference=陈永法, 黄丽. 美国FDA对药物临床试验的监管[J]. 中国新药杂志, 2012, 21(14): 1578-1582., articleTitle=null, refAbstract=null), Reference(id=1322181149338742805, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[25], rfOrder=24, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. New Pediatric Labeling Information Database, September 2019[EB/OL]. [2020-11-04]. https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=labelingdatabase., articleTitle=null, refAbstract=null), Reference(id=1322181149477154838, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322181140711060449, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[26], rfOrder=25, authorNames=null, journalName=null, refType=null, unstructuredReference=药品审评中心. 关于临床急需儿童用药申请优先审评审批品种评定基本原则及首批优先审评品种的公告[EB/OL]. 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