去中心化临床试验的基本原则：策略与执行

English | 2024 | ISBN: 3031628764 | 80 Pages | PDF EPUB (True) | 2 MB

A timely and first-of-its-kind publication in the field, this short handbook on decentralized clinical trials (DCTs) offers a thorough exploration of the potential of DCTs to revolutionize clinical research through innovative approaches, including technology. This concise and easy-to-read publication is especially designed for those who seek to understand and get up-to-speed on what DCTs mean and how to work in this rapidly evolving field. As discussed in Chapter 1, DCTs address barriers to traditional trial participation, promoting accessibility, diversity, equity, and participant engagement. Chapter 2 examines how the COVID-19 pandemic and evolving regulations accelerated the adoption of DCTs, building on their application since the early 2000s. Chapters 3 and 4 highlight remaining operational complexities and the importance of careful trial design to ensure scientific rigor, operational feasibility, and compliance with regulations, ethics, data privacy, and participant safety. The book emphasizes the significance of the FDA's draft guidance on DCTs, detailing investigator responsibilities, local health care providers' use, and essential sponsor considerations. Chapter 5 stresses the need for clear metrics to evaluate DCT adoption's impact on recruitment, retention, diversity, safety, and cost efficiencies. Overall, this guide tracks DCT advancements and encourages readers to contribute to evidence-based integration, meeting participant expectations for convenience and fostering faster, more inclusive clinical studies. Ultimately, this book aims to support the transformation of modern clinical research, developing medical products more efficiently for those in need. A major contribution to the literature on clinical research, this work will be a resourceful tool to anyone interested in embracing decentralized clinical research and improving access and participation for all.

这本及时且独一无二的出版物在该领域内提供了一个简短的手册，介绍去中心化临床试验（DCTs）的潜力，通过创新的方法，包括技术革新来彻底探索如何革命性地改变临床研究。本书专为那些想要理解并迅速熟悉什么是DCT以及如何在这个快速发展的领域中工作而设计，简洁易读。正如第一章所讨论的一样，DCTs解决了传统试验参与中的障碍，从而促进可访问性、多样性、平等性和参与者参与度。第二章探讨了COVID-19大流行和不断变化的法规加速了DCTs的采用，基于自20世纪初以来的应用。第三章和第四章强调了剩余的操作复杂性和精心设计试验的重要性，以确保科学严谨性、操作可行性以及遵守法规、伦理学、数据隐私和参与者安全。本书突出了FDA关于DCTs草案指南的重要意义，详细描述了研究者责任、地方医疗机构的使用以及重要的赞助商考虑因素。第五章强调了制定明确指标来评估DCT采用对招募、留存、多样性、安全性及成本效率的影响的重要性。总的来说，这本书跟踪记录了DCT的进步，并鼓励读者为基于证据的整合贡献自己的力量，满足参与者对便利性的期待，并促进更快、更包容性地进行临床研究。最终，本书旨在支持现代临床研究的转变，以便更多需要的人能够更有效地开发医疗产品。这本著作对于那些希望拥抱去中心化临床研究并提高所有人的访问性和参与度的人来说是一项重要的文献贡献，并且也将成为任何对去中心化临床研究感兴趣的资源工具。

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