Article(id=1291706983506276991, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706966187991876, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.24.022, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1761321600000, receivedDateStr=2025-10-25, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896543623, onlineDateStr=2026-08-05, pubDate=1766851200000, pubDateStr=2025-12-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896543623, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896543623, creator=13701087609, updateTime=1785896543623, updator=13701087609, issue=Issue{id=1291706966187991876, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='24', pageStart='3451', pageEnd='3600', issueExtLink='null', onlineDate='null', pubDate='1766851200000', pubDateStr='2025-12-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896539494, creator='13701087609', updateTime=1785998798662, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292135872292479273, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706966187991876, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292135872296673578, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706966187991876, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3588, endPage=3593, ext={EN=ArticleExt(id=1291706983711797888, articleId=1291706983506276991, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Consideration on clinical research and development of therapeutic drugs for COVID-19, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

To summarize and analyze clinical development strategy and the key considerations of clinical trial design of drugs for the treatment of corona virus disease 2019 (COVID-19) at home and abroad in recent years, including ribonucleic acid (RNA) polymerase inhibitors, 3CL protease inhibitors, and neutralizing antibodies, etc. In general, the confirmatory clinical trials for therapeutic drugs for COVID-19 typically adopt a randomized, double blind, placebo-controlled clinical trials using a superiority design. Based on their therapeutic positioning, most trials mainly enroll patients with mild to moderate COVID-19, with or without high-risk of complications, and the primary efficacy endpoints are the proportion of patients hospitalized or mortality by an appropriate time point, or the time to sustained clinical recovery assessed over an appropriate duration. Through reviewing drug development during the COVID-19 pandemic, this paper summarized the considerations and changes for clinical research and development, as well as the focus of clinical trial design for new drugs in the treatment of COVID-19, in the context of emerging and sudden major infectious diseases, hoping to provide references for drug research and development.

, authors=Chun-li HE, Xiao-wen XU, Shu-ning ZUO, Jian-zhong ZHAO, authorsList=Chun-li HE, Xiao-wen XU, Shu-ning ZUO, Jian-zhong ZHAO, authorCompany=null, correspAuthors=Jian-zhong ZHAO, 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=1291706984017982081, articleId=1291706983506276991, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=新型冠状病毒感染治疗药物临床研发的考虑要点, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

对近年来国内外部分新冠治疗药物，包括核糖核酸（RNA）聚合酶抑制剂、主要蛋白酶（Mpro，也称为3C-样蛋白酶，下文称3CL蛋白酶）抑制剂和中和抗体类药物，针对临床研发策略及试验设计的关键考虑进行了总结与分析。新冠治疗药物确证性临床试验一般采用随机、双盲、安慰剂对照的优效性试验设计，大多数试验入组轻中度患者，伴或不伴有高风险因素，主要疗效指标选择适当时间点住院率或死亡率，或适当时间内至临床症状持续恢复的时间。通过疫情期间药物研发的特点，总结了临床研发策略的考虑与变更，以及新型冠状病毒感染治疗新药临床试验设计的重点关注内容，以期为新发突发重大传染病情况下药物临床研发提供参考。

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何春俐（1992-），女，助理研究员，主要从事药品技术审评工作

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何春俐（1992-），女，助理研究员，主要从事药品技术审评工作

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