Tele-Clinical Trial Platform: Revolutionizing Rare Disease Research and Beyond
This invention is a tele-clinical trial platform designed to enable remote patient enrollment and protocol administration for clinical trials. Its most significant advantage is its ability to expand access to clinical trials for patients across vast geographical locations, especially for rare diseases, while reducing costs and improving efficiency.
Description
The Tele-Clinical Trial platform provides a digital infrastructure that connects patient recruitment with screening, enrollment, and mobile data collection, allowing clinical trials to be managed from a single site, even when in-person visits are necessary. This platform facilitates conducting trials in patients' homes, eliminating the need for visits to major medical centers and significantly increasing the potential subject pool. It integrates various resources such as eligibility surveys, mobile patient consent, automatic randomization, medical history surveys, and facilitation of home delivery of interventions through mobile research nurses. The system also incorporates wireless pill cases for medication adherence monitoring, vitals recording, activity monitoring, mobile adverse event monitoring, and mobile patient-reported outcomes. Furthermore, it supports telemedicine for patient assessments, laboratory testing and reporting, patient-directed functional testing, and remote review of labs, outcomes, and adverse events, all managed through a central database with automatic data checks.Applications
- Clinical trials for rare diseases, which face challenges with patient recruitment and retention.- Pharmaceutical and biotechnology companies seeking to reduce the cost and duration of phase 3 clinical trials.
- Research organizations looking for a platform to manage decentralized clinical trials.
- Development of study-specific mobile applications for patient engagement and data collection in clinical research.
- Integration with online patient recruiting organizations for more effective participant screening and enrollment.
Advantages
- Enables clinical trial sites to enroll patients across vast geographical locations, increasing the potential subject pool.- Reduces the cost and improves the efficiency of clinical trials by allowing remote management and in-home testing.
- Provides a comprehensive digital infrastructure for end-to-end management of remote clinical trials.
- Offers a host of customizable resources to suit the specific needs of various remote clinical trials.
- Facilitates in-home administration of clinical protocols, including drug delivery and sample collection, through mobile research nurses.