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

对罕见病和常见病进行临床试验涉及许多挑战，其中一些最常见的挑战包括研究参与者的识别，招募和保留。虚拟、分散、远程或研究中心不可知试验可用于将以前被排除的个体纳入研究。收集的数据也需要无缝捕获和集成 从多个来源，并有足够的质量，以满足监管要求。移动的技术为远程参与和监测研究受试者以及远程和可靠的数据采集提供了机会。这些技术的开发和使用有可能使更广泛和更多样化的研究人群参与罕见病临床试验，同时提高数据采集质量和试验效率。BioSensics将开发一个强大的集成多模式数据采集平台，可用于在家中和远程环境中评估个人，以用于临床试验。 具体目标 该项目的目标是开发一个强大的、集成的多模式数据采集平台，可用于在家中和远程环境中对个人进行评估，以用于临床试验。该技术将是可靠的，安全的，易于使用的远程监测研究参与者，无论是在家里还是在参与日常生活活动。拟议的平台将允许使用传感器和数字化临床测试以及电子技术测量运动、语言和认知功能。

Conducting clinical trials for both rare and common diseases involve many challenges, some of the most frequent of which include the identification, enrollment, and retention of study participants. Virtual, decentralized, remote or site agnostic trials may be used to include individuals in studies that previously would have been excluded. Data that is collected will also need to be seamlessly captured and integrated from multiple sources and be of sufficient quality to meet regulatory requirements. Mobile technology offers the opportunity for remote participation and monitoring of study subjects, as well as remote and reliable data capture. Development and use of these technologies have the potential to allow for broader and more diverse study populations for participation in clinical trials for rare diseases while simultaneously improving the quality of data capture and efficiency of the trials. BioSensics will develop a robust and integrated multi-modal platform for data capture that can be used to assess individuals at their home and in remote settings for use in clinical trials. Specific Aims The objective of this project is to develop a robust and integrated multi-modal platform for data capture that can be used to assess individuals at their home and in remote settings for use in clinical trials. The technology will be reliable, secure, and easy to use to monitor study participants remotely, either in the home or while participating in activities of daily living. The proposed platform will allow measurements of motor, speech and cognitive functions using sensors and digitized clinical tests, as well as electronic.