去中心化临床试验的基础：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 The book emphasizes the significance of the FDA's draft guidance on DCTs, detailing investigator responsibilities, local health care providers' use, and essential sponsor considerations.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.

一本及时且独一无二的出版物，这本关于分布式临床试验（DCTs）的手册深入探讨了通过创新方法，包括技术，DCTs在临床研究中革命化的潜力。这本书内容简洁易读，尤其设计用于那些希望了解和掌握分布式临床试验含义及其工作方式的读者。正如第一章讨论的那样，分布式临床试验解决了传统参与试验中的障碍，促进了可访问性、多样性、公平性和参与者参与度。第二章探讨了COVID-19疫情以及不断变化的法规如何加速了DCTs的采用，继20世纪初以来对其应用的发展。第三章和第四章强调了剩余的操作复杂性，并突出了精心设计试验的重要性，以确保科学严谨性、可行性以及符合法规要求、伦理学、数据隐私和参与者安全。本书强调了FDA关于分布式临床试验的草拟指南的重要性，详细介绍了研究者的责任、当地医疗机构的应用及关键赞助者的考虑事项。第五章指出需要明确的指标来评估分布式临床试验对招募、保留、多样性、安全性以及成本效率的影响。总的来说，这本手册追踪分布式临床试验的进步，并鼓励读者为基于证据的整合做出贡献，以满足参与者对于便捷性的期望并促进更快速和包容性更强的临床研究。最终，这本书旨在支持现代临床研究的转型，使医疗产品能够更快地为有需要的人提供帮助。作为临床研究文献中的重大贡献，这部作品将对任何希望拥抱分布式临床研究以及提高所有人可及性和参与度感兴趣的人来说都是一项宝贵工具。

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