{"title":"临床试验设计:简化概述","authors":"Pranali M. Wandile","doi":"10.18203/2349-3259.ijct20232153","DOIUrl":null,"url":null,"abstract":"Clinical trials aim to invent new, better, safer, more effective ways to prevent, detect, or treat health conditions and to compare them to existing standards of care as applicable. This scientific inquiry prompts researchers to design and develop proposed clinical trial protocols to evaluate preliminary information about the product and develop research questions and objectives. The average budget for new product development is enormous, and this eventuality is because almost 90 percent of a trial drugs never get approved. Hence, having an appropriate clinical trial design is crucial for successful product development. A trial's ability to deliver the proposed indication relies on its suitable design, background information, the trial justification to sample size, interim monitoring rules, and ways to review and analyze study data. In this article, we presented an overview of clinical trial designs emphasizing adaptive designs in a simplified way for field-based clinical research professionals.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"38 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical trial designs: a simplified overview\",\"authors\":\"Pranali M. Wandile\",\"doi\":\"10.18203/2349-3259.ijct20232153\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Clinical trials aim to invent new, better, safer, more effective ways to prevent, detect, or treat health conditions and to compare them to existing standards of care as applicable. This scientific inquiry prompts researchers to design and develop proposed clinical trial protocols to evaluate preliminary information about the product and develop research questions and objectives. The average budget for new product development is enormous, and this eventuality is because almost 90 percent of a trial drugs never get approved. Hence, having an appropriate clinical trial design is crucial for successful product development. A trial's ability to deliver the proposed indication relies on its suitable design, background information, the trial justification to sample size, interim monitoring rules, and ways to review and analyze study data. In this article, we presented an overview of clinical trial designs emphasizing adaptive designs in a simplified way for field-based clinical research professionals.\",\"PeriodicalId\":13787,\"journal\":{\"name\":\"International Journal of Clinical Trials\",\"volume\":\"38 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-07-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Clinical Trials\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.18203/2349-3259.ijct20232153\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Trials","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.18203/2349-3259.ijct20232153","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Clinical trials aim to invent new, better, safer, more effective ways to prevent, detect, or treat health conditions and to compare them to existing standards of care as applicable. This scientific inquiry prompts researchers to design and develop proposed clinical trial protocols to evaluate preliminary information about the product and develop research questions and objectives. The average budget for new product development is enormous, and this eventuality is because almost 90 percent of a trial drugs never get approved. Hence, having an appropriate clinical trial design is crucial for successful product development. A trial's ability to deliver the proposed indication relies on its suitable design, background information, the trial justification to sample size, interim monitoring rules, and ways to review and analyze study data. In this article, we presented an overview of clinical trial designs emphasizing adaptive designs in a simplified way for field-based clinical research professionals.