Clinical Trial Platform Using Centralized Data for Decentralized Access
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Solution Overview
Problem
The clinical trials enterprise faces challenges in sustainability due to the lack of involvement of community physicians and difficulties in recruiting and retaining appropriate human subject populations, particularly affecting marginalized and underrepresented communities.
Innovation Solution
A computer system programmed to provide access to clinical investigation participants, comprising a server with modules for clinical investigation providers, participants, and investigators, utilizing algorithms for eligibility decisions based on inclusion and exclusion criteria, and integrating with electronic health records and treatment compliance programs.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If decentralized clinical trials are expanded to increase access to under-represented populations, then diversity and representativeness of participant population is improved, but data quality and reliability deteriorate due to multiple data sources
Solution Approach 1:
The patent introduces a centralized data management system as an intermediary between multiple decentralized data sources (electronic health records, wearables, patient-reported outcomes) and the clinical trial analysis. This intermediary layer standardizes and validates data from diverse sources, ensuring consistent quality while maintaining the benefits of decentralized trial expansion.
Solution Approach 2:
The system implements standardized data collection parameters and protocols across all decentralized sites. By establishing uniform measurement criteria, data types, and validation rules, the system maintains data quality consistency regardless of the location or source of the data, enabling reliable analysis while expanding access.
2Ease of operation
If community physicians are involved in clinical trial conduct to improve sustainability, then ease of operation and provider engagement is improved, but device complexity and system requirements worsen
Solution Approach 1:
The system provides self-service tools for community physicians, including automated eligibility screening, electronic consent forms, and integrated data collection capabilities. These tools enable providers to conduct trial activities directly in their practice without requiring complex infrastructure or specialized training, thereby improving engagement while managing system complexity.
Solution Approach 2:
The platform is designed as a universal system that can be integrated with various existing electronic health record systems and data sources. This multi-functional approach allows the same system to serve different provider types and settings, simplifying implementation while maintaining comprehensive functionality for diverse clinical environments.
3Adaptability or versatility
If multiple data sources are integrated to improve trial comprehensiveness, then adaptability and data richness are improved, but device complexity and data management burden worsen
Solution Approach 1:
The data management system is segmented into modular components that handle different data types (electronic health records, wearable devices, patient surveys, laboratory data) separately but integrate them through standardized protocols. This segmentation reduces the complexity of managing diverse data sources by treating each with specialized processing while maintaining overall system coherence.
Solution Approach 2:
The system incorporates real-time data quality feedback mechanisms that automatically validate incoming data from multiple sources and provide immediate correction guidance. This feedback loop ensures data integrity while simplifying management by automating quality control and reducing the need for manual verification across diverse data sources.
Data Source
AI summary
A computer system programmed for providing access to at least one clinical investigation participant participating in at least one clinical investigation. In one embodiment, the system includes a clinical investigation provider module adapted for receiving, storing, and providing data in communication with at least one clinical investigation provider at the point of care, a clinical investigation participant module adapted for receiving, storing, and providing data in communication with the at least one clinical investigation participant, and, a clinical investigation data module adapted for receiving, storing, and providing data in communication with at least one clinical investigator. Each of the clinical investigation participant module, clinical investigation provider module, and clinical investigation data module is operatively associated with a corresponding one of the at least one clinical trial provider, at least one clinical investigation participant, and at least one clinical investigator through a network.