{"title":"临床试验的设计和实施","authors":"Anthony Lockett","doi":"10.1016/j.mpmed.2025.04.001","DOIUrl":null,"url":null,"abstract":"<div><div>This article provides an overview of the clinical and scientific challenges that must be considered in developing a clinical trial. Here, the clinical, scientific and regulatory setting of clinical trials are considered. In particular, the article discusses the issues surrounding the identification of the target population, definition of the treatment, choice of clinical outcomes and choice of comparators. It includes a discussion of the choice of randomization strategies, blinding, conduct and monitoring of the study, and plans for reporting the results. The importance of a well-defined study protocol is emphasized.</div></div>","PeriodicalId":74157,"journal":{"name":"Medicine (Abingdon, England : UK ed.)","volume":"53 6","pages":"Pages 355-357"},"PeriodicalIF":0.0000,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical trial design and conduct\",\"authors\":\"Anthony Lockett\",\"doi\":\"10.1016/j.mpmed.2025.04.001\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><div>This article provides an overview of the clinical and scientific challenges that must be considered in developing a clinical trial. Here, the clinical, scientific and regulatory setting of clinical trials are considered. In particular, the article discusses the issues surrounding the identification of the target population, definition of the treatment, choice of clinical outcomes and choice of comparators. It includes a discussion of the choice of randomization strategies, blinding, conduct and monitoring of the study, and plans for reporting the results. The importance of a well-defined study protocol is emphasized.</div></div>\",\"PeriodicalId\":74157,\"journal\":{\"name\":\"Medicine (Abingdon, England : UK ed.)\",\"volume\":\"53 6\",\"pages\":\"Pages 355-357\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-04-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Medicine (Abingdon, England : UK ed.)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S135730392500074X\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Medicine (Abingdon, England : UK ed.)","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S135730392500074X","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
This article provides an overview of the clinical and scientific challenges that must be considered in developing a clinical trial. Here, the clinical, scientific and regulatory setting of clinical trials are considered. In particular, the article discusses the issues surrounding the identification of the target population, definition of the treatment, choice of clinical outcomes and choice of comparators. It includes a discussion of the choice of randomization strategies, blinding, conduct and monitoring of the study, and plans for reporting the results. The importance of a well-defined study protocol is emphasized.
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