PDF(Pubmed)
Abstract：
N-of-1 trials are the gold standard study design to evaluate individual treatment effects and derive personalized treatment strategies. Digital tools have the potential to initiate a new era of N-of-1 trials in terms of scale and scope, but fully functional platforms are not yet available. Here, we present the open source StudyU platform, which includes the StudyU Designer and StudyU app. With the StudyU Designer, scientists are given a collaborative web application to digitally specify, publish, and conduct N-of-1 trials. The StudyU app is a smartphone app with innovative user-centric elements for participants to partake in trials published through the StudyU Designer to assess the effects of different interventions on their health. Thereby, the StudyU platform allows clinicians and researchers worldwide to easily design and conduct digital N-of-1 trials in a safe manner. We envision that StudyU can change the landscape of personalized treatments both for patients and healthy individuals, democratize and personalize evidence generation for self-optimization and medicine, and can be integrated in clinical practice.
摘要：
N-of-1试验是评估个体治疗效果并得出个性化治疗策略的黄金标准研究设计。数字工具有可能在规模和范围方面开启N-of-1试验的新时代，但功能齐全的平台还没有。这里,我们介绍了开源的StudyU平台，其中包括StudyU设计器和StudyU应用程序。有了StudyU设计师，科学家们得到了一个协作的网络应用程序来数字化指定，发布,并进行N-of-1试验。StudyU应用程序是一款智能手机应用程序，具有以用户为中心的创新元素，参与者可以参与通过StudyU设计师发布的试验，以评估不同干预措施对他们健康的影响。因此，StudyU平台允许全球的临床医生和研究人员以安全的方式轻松设计和进行数字N-of-1试验.我们设想StudyU可以改变患者和健康个体的个性化治疗的格局，民主化和个性化证据生成，以实现自我优化和医学，并可融入临床实践。
