TOPIC 022 - TECHNOLOGICAL DEVELOPMENT AND VALIDATION OF REMOTE MEASURES FORUSE IN CLINICAL TRIALS IN INDIVIDUALS WITH RARE DISEASES

主题 022 - 用于罕见疾病个体临床试验的远程测量的技术开发和验证

• 批准号: 10710446
• 负责人: DAVID BOONE
• 金额: $ 32.48万
• 依托单位: ORTHOCARE INNOVATIONS, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-23 至 2023-06-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10710446
• 关键词: Caring; Clinical Trials; Computer software; Development; Disease; Geography; Individual; Internet of Things; Location; Measures; Medical; Monitor; Participant; Patients; Phase; Population; Rare Diseases; Research; Research Personnel; Technology; Validation; data access; data exchange; innovation; interest; novel; recruit; virtual

There is a present need for development of novel means for assessing and monitoring research participants remotely. In research on rare diseases, the population of interest is likely geographically dispersed and already burdened by ongoing care for their disease. It is not always practical, reasonable, or economical to recruit and retain participants when asking them to access research locations that may be far away and inconvenient. Technology enabling remote and virtual participation in trials will enable researchers to include participants that otherwise would have been excluded from participation. In this Phase I project, the Orthocare Innovations team will develop an integrated hardware, software, and data access platform for remote patient assessment, called StepWatch Remote.

目前需要开发新的手段来远程评估和监测研究参与者。在对罕见疾病的研究中，感兴趣的人群可能 地理上分散的，已经承担着对他们的疾病进行持续护理的负担。在要求参与者访问可能较远和不方便的研究地点时，招募和留住参与者并不总是实用、合理或经济的。能够远程和虚拟参与试验的技术将使研究人员能够包括原本会被排除在参与之外的参与者。在这个第一阶段项目中，Orthocare创新团队将开发一个用于远程患者评估的集成硬件、软件和数据访问平台，称为StepWatch Remote。