Agile by adaptive design: An algorithm for decentralized trials

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2026-01-01 Epub Date: 2025-11-24 DOI:10.1016/j.cct.2025.108169

K. Shuvo Bakar

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引用次数: 0

Abstract

Decentralized Clinical Trials (DCTs) represent a significant advancement in clinical research, offering greater accessibility, flexibility, and participant engagement through the use of telemedicine, mobile health technologies, and remote data capture. However, the decentralized nature of data collection introduces challenges related to data reliability and variability, which are often inadequately addressed by conventional statistical methods at the design stage of the trial.

This study presents an agile Bayesian design framework tailored to the specific needs of DCTs, integrating adaptive data reliability directly into trial design and analysis. Our approach is based on Bayesian decision rules to guide interim sample size adjustments. By treating data reliability as a model parameter rather than an external factor, our method accounts for uncertainty and improves the robustness of power calculations.

Simulation studies demonstrate the effectiveness of this strategy. The proposed framework enables a flexible and agile approach to DCT design that can adapt to varying data quality conditions. This work offers a foundation for extending the proposed adaptive method to other trial contexts, including time-to-event endpoints, and supports the broader adoption of DCTs in real-world clinical research.

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自适应设计的敏捷：一种分散试验的算法

分散临床试验（dct）代表了临床研究的重大进步，通过使用远程医疗、移动卫生技术和远程数据采集，提供了更大的可及性、灵活性和参与者参与。然而，数据收集的分散性带来了与数据可靠性和可变性相关的挑战，在试验设计阶段，传统统计方法往往不能充分解决这些问题。本研究提出了一个灵活的贝叶斯设计框架，为dct的特定需求量身定制，将自适应数据可靠性直接集成到试验设计和分析中。我们的方法是基于贝叶斯决策规则来指导临时样本量调整。通过将数据可靠性作为模型参数而不是外部因素，我们的方法考虑了不确定性并提高了功率计算的鲁棒性。仿真研究证明了该策略的有效性。所提出的框架为DCT设计提供了灵活和敏捷的方法，可以适应不同的数据质量条件。这项工作为将所提出的自适应方法扩展到其他试验环境（包括时间到事件终点）提供了基础，并支持在现实世界的临床研究中更广泛地采用dct。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.