In this Review, we explore the transformative potential of decentralized clinical trials (DCTs) in addressing the limitations of traditional randomized controlled trials (RCTs). We highlight the merits of DCTs fostering greater inclusivity, efficiency, and adaptability. We emphasize the challenges of RCTs, including limited participant diversity and logistical barriers, geographical constraints, and mistrust in research institutions, showing how DCTs are preferred in addressing these challenges by utilizing remote digital technologies and community providers to enable broader, more inclusive participation. Furthermore, we underscore the potential of DCTs for democratizing clinical research. We also stress the importance of addressing unresolved challenges, including data security and privacy, remote patient monitoring, and regulatory variations. Research is needed to devise standardized protocols to streamline DCT processes, explore its long-term impacts on patient outcomes, and overcome challenges through equitable stakeholder engagement.

中文翻译：

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分散临床试验的价值：包容性、可及性和创新


在这篇综述中，我们探讨了分散临床试验（DCT）在解决传统随机对照试验（RCT）局限性方面的变革潜力。我们强调 DCT 在促进更大包容性、效率和适应性方面的优点。我们强调 RCT 的挑战，包括有限的参与者多样性和后勤障碍、地理限制以及对研究机构的不信任，表明 DCT 如何通过利用远程数字技术和社区提供者来实现更广泛、更具包容性的参与来应对这些挑战。此外，我们强调 DCT 在临床研究民主化方面的潜力。我们还强调解决尚未解决的挑战的重要性，包括数据安全和隐私、远程患者监控和监管变化。需要进行研究来制定标准化协议，以简化 DCT 流程，探索其对患者结果的长期影响，并通过公平的利益相关者参与来克服挑战。