通过使用统计创新、技术和非标准数据源，重新设想临床试验效率的优化。

IF 1.2 4区医学 Q4 PHARMACOLOGY & PHARMACY

Journal of Biopharmaceutical Statistics Pub Date : 2025-04-10 DOI:10.1080/10543406.2025.2489289

Kannan Natarajan, Demissie Alemayehu

{"title":"通过使用统计创新、技术和非标准数据源，重新设想临床试验效率的优化。","authors":"Kannan Natarajan, Demissie Alemayehu","doi":"10.1080/10543406.2025.2489289","DOIUrl":null,"url":null,"abstract":"With the ever-growing cost of conducting traditional clinical trials and evolving regulatory paradigms, the need to deliver new medicines with speed and efficiency has become increasingly urgent. There are complex and innovative design approaches, emerging technologies, and abundant data sources that can be leveraged to address these challenges. However, their potential is not fully realized due to operational constraints and regulatory hurdles. We review the vast array of tools and technologies that are available, discuss their capabilities and limitations, and propose strategies for maximizing the efficiency of clinical trials through effective deployment of existing and new approaches.","PeriodicalId":54870,"journal":{"name":"Journal of Biopharmaceutical Statistics","volume":" ","pages":"1-11"},"PeriodicalIF":1.2000,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Reimagining optimization of clinical trials efficiency through use of statistical innovation, technology and non-standard data sources.\",\"authors\":\"Kannan Natarajan, Demissie Alemayehu\",\"doi\":\"10.1080/10543406.2025.2489289\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"With the ever-growing cost of conducting traditional clinical trials and evolving regulatory paradigms, the need to deliver new medicines with speed and efficiency has become increasingly urgent. There are complex and innovative design approaches, emerging technologies, and abundant data sources that can be leveraged to address these challenges. However, their potential is not fully realized due to operational constraints and regulatory hurdles. We review the vast array of tools and technologies that are available, discuss their capabilities and limitations, and propose strategies for maximizing the efficiency of clinical trials through effective deployment of existing and new approaches.\",\"PeriodicalId\":54870,\"journal\":{\"name\":\"Journal of Biopharmaceutical Statistics\",\"volume\":\" \",\"pages\":\"1-11\"},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2025-04-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Biopharmaceutical Statistics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/10543406.2025.2489289\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Biopharmaceutical Statistics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/10543406.2025.2489289","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

摘要

随着开展传统临床试验的成本不断增加和监管模式不断演变，快速高效地提供新药的需求变得越来越迫切。可以利用复杂而创新的设计方法、新兴技术和丰富的数据源来应对这些挑战。然而，由于操作限制和监管障碍，它们的潜力尚未充分实现。我们回顾了大量可用的工具和技术，讨论了它们的能力和局限性，并提出了通过有效部署现有和新方法来最大化临床试验效率的策略。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Reimagining optimization of clinical trials efficiency through use of statistical innovation, technology and non-standard data sources.

With the ever-growing cost of conducting traditional clinical trials and evolving regulatory paradigms, the need to deliver new medicines with speed and efficiency has become increasingly urgent. There are complex and innovative design approaches, emerging technologies, and abundant data sources that can be leveraged to address these challenges. However, their potential is not fully realized due to operational constraints and regulatory hurdles. We review the vast array of tools and technologies that are available, discuss their capabilities and limitations, and propose strategies for maximizing the efficiency of clinical trials through effective deployment of existing and new approaches.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Journal of Biopharmaceutical Statistics 医学-统计学与概率论

CiteScore

2.50

自引率

18.20%

发文量

审稿时长

6-12 weeks

期刊介绍： The Journal of Biopharmaceutical Statistics, a rapid publication journal, discusses quality applications of statistics in biopharmaceutical research and development. Now publishing six times per year, it includes expositions of statistical methodology with immediate applicability to biopharmaceutical research in the form of full-length and short manuscripts, review articles, selected/invited conference papers, short articles, and letters to the editor. Addressing timely and provocative topics important to the biostatistical profession, the journal covers: Drug, device, and biological research and development; Drug screening and drug design; Assessment of pharmacological activity; Pharmaceutical formulation and scale-up; Preclinical safety assessment; Bioavailability, bioequivalence, and pharmacokinetics; Phase, I, II, and III clinical development including complex innovative designs; Premarket approval assessment of clinical safety; Postmarketing surveillance; Big data and artificial intelligence and applications.