Decentralized Clinical Data Collection System
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Traditional clinical trial data collection methods are inconvenient for patients, leading to high dropout rates and significant costs for sponsors, as patients must frequently commute to trial sites, resulting in inefficiencies and increased expenses.
Innovation Solution
A decentralized system for collecting clinical and non-clinical trial data using client devices over networks, allowing data collection at hospitals, homes, or alternate care facilities by patients or healthcare professionals, with real-time transmission and access for sponsors, leveraging technologies like SMAC, AI/ML, and Bluetooth integration for seamless data capture and analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If patients frequently visit trial sites for data collection, then data quality is improved, but patient burden and dropout rates increase
Solution Approach 1:
Patients use mobile devices to self-report clinical data, symptoms, and outcomes at home without requiring visits to trial sites. The system enables patients to independently complete assessments, enter data, and communicate with study personnel remotely, eliminating the need for frequent in-person visits while maintaining data collection quality
Solution Approach 2:
Physical visits to trial sites are replaced by electronic data transmission systems. Mobile applications, wearable devices, and telemedicine platforms capture and transmit clinical data electronically, substituting the mechanical process of patient travel and in-person data entry with automated digital collection methods
2Quantity of substance
If patients frequently visit trial sites, then comprehensive data is collected, but time and cost expenses increase
Solution Approach 1:
The system enables continuous data collection in patients' natural environments without interruption to their daily routines. Data can be captured continuously through wearable devices and mobile applications, eliminating the discontinuous nature of periodic site visits and reducing the time lost to travel and waiting
Solution Approach 2:
Mobile devices and telemedicine platforms serve as intermediaries between patients and trial sites. These intermediaries capture, store, and transmit data electronically, eliminating the need for patients to physically travel to sites while ensuring comprehensive data collection through automated processes
3Reliability
If traditional in-person data collection is used, then data verification is thorough, but operational complexity and costs increase
Solution Approach 1:
The system incorporates automated feedback mechanisms where data entered by patients is immediately validated against pre-defined criteria, protocols, and ranges. The platform provides real-time feedback to patients about data quality issues, missing information, or protocol violations, enabling immediate correction without requiring manual verification at trial sites
Solution Approach 2:
The digital platform performs multiple functions including data collection, validation, storage, analysis, and communication through a single integrated system. This multi-functional approach replaces the complex multi-step process of manual data collection, verification, entry, and transfer that occurs in traditional in-person trials, simplifying operations while maintaining reliability
Data Source
AI summary
Systems and methods for collecting clinical trial data across multiple locations is described. One described method; decentralized clinical trial design; comprises collecting clinical and non-clinical data on a client device over a network; the data is collected at a hospital, home or an alternate care facility, by either the patient or the healthcare professional; and transmitting the data, for access to sponsors over the network.