加速药物开发:缩短临床试验的管理和操作策略

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引用次数: 0

摘要

本文探讨了旨在通过缩短临床试验加速药物开发的各种监管和操作策略。传统临床试验的时间较长,给患者及时提供治疗带来了挑战,因此,在不影响安全性或数据完整性的情况下,找到加速治疗过程的方法至关重要。讨论的策略包括适应性试验设计、利用替代终点、利用真实世界证据、监管灵活性、简化的方案和程序以及加强患者招募和登记。通过实施这些策略,研究人员可以做出明智的决策,加快数据分析,提高试验效率。文章强调了利益相关者之间合作的重要性,以推动临床试验领域的发展,并更快地为患者带来创新疗法
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Accelerating Drug Development: Regulatory and Operational Strategies for Shortening Clinical Trials
This article explores various regulatory and operational strategies aimed at accelerating drug development by shortening clinical trials. The length of traditional clinical trials presents challenges in delivering timely therapies to patients, making it crucial to identify approaches that expedite the process without compromising safety or data integrity. The strategies discussed include adaptive trial designs, utilizing surrogate endpoints, leveraging real-world evidence, regulatory flexibility, streamlined protocols and procedures, and enhanced patient recruitment and enrollment. By implementing these strategies, researchers can make informed decisions, expedite data analysis, and enhance trial efficiency. The article emphasizes the importance of collaboration among stakeholders to advance the field of clinical trials and bring innovative therapies to patients more quickly
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