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

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.