Article(id=1322246429112909937, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, 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=1600963200000, acceptedDateStr=2020-09-25, onlineDate=1793177714851, onlineDateStr=2026-10-28, pubDate=1624982400000, pubDateStr=2021-06-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793177714851, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793177714851, creator=13701087609, updateTime=1793177714851, updator=13701087609, issue=Issue{id=1322246421869346895, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='12', pageStart='1057', pageEnd='1152', issueExtLink='null', onlineDate='null', pubDate='1624982400000', pubDateStr='2021-06-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793177713123, creator='13701087609', updateTime=1793178158604, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322248290402414824, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322248290402414825, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322246421869346895, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1099, endPage=1102, ext={EN=ArticleExt(id=1322246430920654962, articleId=1322246429112909937, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis of follow-up for subjects of anti-cancer clinical trials under COVID-19, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To analyze the follow-up changes of subjects of anti-cancer clinical trials in our department under the COVID-19 epidemic situation.

Methods:

The clinical trials were classified. The follow-up status of subjects in our department from February 3 to April 30 and May 6 to 29, 2020 was collected, and the data were input and analyzed by Excel and SPSS 22.0.

Results:

There were 32 anti-cancer clinical trials in our department. From February 3 to April 30, 2020, 1 049 person times were planned to be followed up, and 658 person times were actually followed up, accounting for 62.73%. The follow-up rate of oral drugs was 93.33%, that of oral drugs combined with non-oral drugs was 87.73%, and that of non-oral drugs was 70.71%. In May 2020, the actual follow-up rate of subjects on site rose to 88.97%, while the number of delayed drug users, the number of external hospital inspectors and the number of non-drug users decreased.

Conclusion:

The epidemic situation had a great impact on the follow-up of anti-cancer clinical trials in a short time, but did not cause a sustained impact. The establishment of relevant follow-up measures improved the follow-up rate of subjects to some extent. For the affected subject population, further analysis is needed to better guide the follow-up work of subjects under emergency.

, authors=Dan LI, Xiao-hong LIU, Dong-qing LU, Kang JIAN, authorsList=Dan LI, Xiao-hong LIU, Dong-qing LU, Kang JIAN, authorCompany=null, correspAuthors=null, 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=1322246431168118899, articleId=1322246429112909937, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=新型冠状病毒肺炎疫情下抗肿瘤药物临床试验受试者的随访分析, 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=
目的:

分析新型冠状病毒肺炎疫情下我院抗肿瘤药物临床试验受试者的随访变化。

方法:

依据院内临床试验工作指南,制定抗肿瘤药物临床试验分类措施,收集疫情下2020年2月3日至4月30日及5月6日至29日受试者的随访状况,使用EXCEL及SPSS 22.0进行数据录入和分析。

结果:

抗肿瘤药物临床试验进行中项目共32项,2020年2月3日至4月30日计划随访1 049人次,实际来院随访为658人次,占比62.73%。其中口服药随访率93.33%,口服药联合非口服药随访率87.73%,而非口服药随访率为70.71%。2020年5月,受试者实际来院随访升至88.97%,而延期用药人次数、外院检查人次数及未用药人次数占比降低。

结论:

疫情对于抗肿瘤药临床试验的随访短期内产生了较大影响,但未造成持续影响。相关随访措施的制定一定程度上改善了受试者的随访率。对于受影响的受试者人群还需要进一步分析,以更好指导后续的紧急事件下的受试者随访工作。

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李丹,女,主管护师,主要从事药物临床试验及研究护士相关研究。E-mail:。

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新型冠状病毒肺炎疫情下抗肿瘤药物临床试验受试者的随访分析
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李丹 , 刘晓红 , 卢冬青 , 见康
中国新药杂志 | 药物临床试验规范与进展专栏 2021,30(12): 1099-1102
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中国新药杂志 |药物临床试验规范与进展专栏 2021 , 30 (12) : 1099 -1102
新型冠状病毒肺炎疫情下抗肿瘤药物临床试验受试者的随访分析
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李丹 , 刘晓红, 卢冬青, 见康
作者信息
  • 北京大学肿瘤医院暨北京市肿瘤防治研究所国家药物临床试验机构,恶性肿瘤发病机制及转化研究教育部重点实验室,北京 100142
作者简介:

李丹,女,主管护师,主要从事药物临床试验及研究护士相关研究。E-mail:。

Analysis of follow-up for subjects of anti-cancer clinical trials under COVID-19
Dan LI , Xiao-hong LIU, Dong-qing LU, Kang JIAN
Affiliations
  • Key Laboratory of Carcinogenesis and Translational Research, Ministry of Education, National Drug Clinical Trial Center, Peking University Cancer Hospital & Institute, Beijing 100142, China
出版时间: 2021-06-30
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目的:

分析新型冠状病毒肺炎疫情下我院抗肿瘤药物临床试验受试者的随访变化。

方法:

依据院内临床试验工作指南,制定抗肿瘤药物临床试验分类措施,收集疫情下2020年2月3日至4月30日及5月6日至29日受试者的随访状况,使用EXCEL及SPSS 22.0进行数据录入和分析。

结果:

抗肿瘤药物临床试验进行中项目共32项,2020年2月3日至4月30日计划随访1 049人次,实际来院随访为658人次,占比62.73%。其中口服药随访率93.33%,口服药联合非口服药随访率87.73%,而非口服药随访率为70.71%。2020年5月,受试者实际来院随访升至88.97%,而延期用药人次数、外院检查人次数及未用药人次数占比降低。

结论:

疫情对于抗肿瘤药临床试验的随访短期内产生了较大影响,但未造成持续影响。相关随访措施的制定一定程度上改善了受试者的随访率。对于受影响的受试者人群还需要进一步分析,以更好指导后续的紧急事件下的受试者随访工作。

新型冠状病毒肺炎  /  抗肿瘤药物临床试验  /  受试者  /  随访
Objective:

To analyze the follow-up changes of subjects of anti-cancer clinical trials in our department under the COVID-19 epidemic situation.

Methods:

The clinical trials were classified. The follow-up status of subjects in our department from February 3 to April 30 and May 6 to 29, 2020 was collected, and the data were input and analyzed by Excel and SPSS 22.0.

Results:

There were 32 anti-cancer clinical trials in our department. From February 3 to April 30, 2020, 1 049 person times were planned to be followed up, and 658 person times were actually followed up, accounting for 62.73%. The follow-up rate of oral drugs was 93.33%, that of oral drugs combined with non-oral drugs was 87.73%, and that of non-oral drugs was 70.71%. In May 2020, the actual follow-up rate of subjects on site rose to 88.97%, while the number of delayed drug users, the number of external hospital inspectors and the number of non-drug users decreased.

Conclusion:

The epidemic situation had a great impact on the follow-up of anti-cancer clinical trials in a short time, but did not cause a sustained impact. The establishment of relevant follow-up measures improved the follow-up rate of subjects to some extent. For the affected subject population, further analysis is needed to better guide the follow-up work of subjects under emergency.

COVID-19  /  anti-cancer clinical trial  /  subjects  /  follow-up
李丹, 刘晓红, 卢冬青, 见康. 新型冠状病毒肺炎疫情下抗肿瘤药物临床试验受试者的随访分析. 中国新药杂志, 2021 , 30 (12) : 1099 -1102 .
Dan LI, Xiao-hong LIU, Dong-qing LU, Kang JIAN. Analysis of follow-up for subjects of anti-cancer clinical trials under COVID-19[J]. Chinese Journal of New Drugs, 2021 , 30 (12) : 1099 -1102 .

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2021年第30卷第12期
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  • 首发时间:2026-10-28
  • 出版时间:2021-06-30
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    北京大学肿瘤医院暨北京市肿瘤防治研究所国家药物临床试验机构,恶性肿瘤发病机制及转化研究教育部重点实验室,北京 100142
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
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红菇属 Russula 17 8.13
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