Clinical trial designs: a simplified overview

Pranali M. Wandile
{"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}
引用次数: 0

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.
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
临床试验设计:简化概述
临床试验的目的是发明新的、更好的、更安全的、更有效的方法来预防、检测或治疗健康状况,并将其与现有的适用护理标准进行比较。这种科学调查促使研究人员设计和制定拟议的临床试验方案,以评估有关产品的初步信息,并制定研究问题和目标。新产品开发的平均预算是巨大的,这种可能性是因为几乎90%的试验药物从未获得批准。因此,有一个适当的临床试验设计是成功的产品开发的关键。试验提供建议适应症的能力取决于其适当的设计、背景信息、试验对样本量的论证、临时监测规则以及审查和分析研究数据的方法。在这篇文章中,我们介绍了临床试验设计的概述,强调以一种简化的方式为现场临床研究专业人员提供适应性设计。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
自引率
0.00%
发文量
0
期刊最新文献
The effectiveness of video feedback intervention on mother-infant interactional quality for women with perinatal mental health illnesses: protocol for a pilot randomised control trial Perioperative management of hyperglycemic patients undergoing surgery: an observational cross sectional study in a tertiary care hospital Perception of decentralized clinical trials and home nursing in oncology clinical research: insights from a survey of clinical research professionals across experimental sites A randomized clinical study comparing Trupler skin stapler and Trulon polyamide suture in post-surgical skin closure during orthopaedic and open abdominal surgeries Immediate effects of bandha hasta utthanasana on cerebral hemodynamics in healthy individuals: a protocol for randomized controlled trial
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1