Merck & Co., Inc., Kenilworth, New Jersey, USA.
Clin Transl Sci. 2021 Mar;14(2):445-459. doi: 10.1111/cts.12910. Epub 2020 Nov 30.
The rapidly advancing field of digital health technologies provides a great opportunity to radically transform the way clinical trials are conducted and to shift the clinical trial paradigm from a site-centric to a patient-centric model. Merck's (Kenilworth, NJ) digitally enabled clinical trial initiative is focused on introduction of digital technologies into the clinical trial paradigm to reduce patient burden, improve drug adherence, provide a means of more closely engaging with the patient, and enable higher quality, faster, and more frequent data collection. This paper will describe the following four key areas of focus from Merck's digitally enabled clinical trials initiative, along with corresponding enabling technologies: (i) use of technologies that can monitor and improve drug adherence (smart dosing), (ii) collection of pharmacokinetic (PK), pharmacodynamic (PD), and biomarker samples in an outpatient setting (patient-centric sampling), (iii) use of digital devices to collect and measure physiological and behavioral data (digital biomarkers), and (iv) use of data platforms that integrate digital data streams, visualize data in real-time, and provide a means of greater patient engagement during the trial (digital platform). Furthermore, this paper will discuss the synergistic power in implementation of these approaches jointly within a trial to enable better understanding of adherence, safety, efficacy, PK, PD, and corresponding exposure-response relationships of investigational therapies as well as reduced patient burden for clinical trial participation. Obstacle and challenges to adoption and full realization of the vision of patient-centric, digitally enabled trials will also be discussed.
数字健康技术的快速发展为彻底改变临床试验的进行方式提供了绝佳的机会，并将临床试验模式从以站点为中心转变为以患者为中心。默克公司（新泽西州肯尼沃斯）的数字化临床试验计划专注于将数字技术引入临床试验模式，以减轻患者负担、提高药物依从性、提供更密切接触患者的手段，并实现更高质量、更快、更频繁的数据收集。本文将介绍默克数字化临床试验计划的以下四个重点关注领域，以及相应的使能技术：（i）使用可监测和改善药物依从性的技术（智能剂量），（ii）在门诊环境中收集药代动力学（PK）、药效动力学（PD）和生物标志物样本（以患者为中心的采样），（iii）使用数字设备收集和测量生理和行为数据（数字生物标志物），以及（iv）使用整合数字数据流、实时可视化数据并提供试验期间更好的患者参与手段的数据平台（数字平台）。此外，本文还将讨论在试验中联合实施这些方法的协同作用，以更好地了解研究治疗的依从性、安全性、疗效、PK、PD 以及相应的暴露-反应关系，并减轻患者参与临床试验的负担。还将讨论采用和充分实现以患者为中心、数字化试验的愿景所面临的障碍和挑战。
