Digital Therapeutics Trial Data Lake for Cross-Phase Correlation
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Solution Overview
Problem
Existing clinical trial systems for digital therapeutics face challenges in integrating data across different phases and databases, leading to inefficiencies, unnecessary duplication, and increased costs due to the lack of communication and integration among separate databases, which complicates data correlation and compliance with regulations.
Innovation Solution
A centralized data management system, or data lake, is implemented to store and manage data from all phases of digital therapeutics trials, allowing for easy integration and correlation of data across trials, reducing duplication, and providing a unified user interface for multiple trials, thus enhancing data security and compliance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If separate databases are used to manage data from different phases of digital therapeutics trials, then data can be collected and stored according to specific phase requirements, but the databases cannot communicate with each other making it difficult to correlate data across phases
Solution Approach 1:
The patent merges separate databases for pre-trial, clinical trial, and post-trial phases into a single centralized database. This allows all data from different phases to be stored in one location and correlated through participant identifiers, resolving the communication gap between separate databases while maintaining phase-specific data collection capabilities.
Solution Approach 2:
The centralized database serves multiple functions: it stores data from all three trial phases, enables data correlation across phases, and provides a unified interface for accessing any phase's data. This multi-functional design eliminates the need for separate database systems while maintaining the specialized data collection requirements of each phase.
2Ease of manufacture
If separate databases are maintained by separate entities in separate locations, then each database can be independently managed, but additional effort is required to ensure each database complies with regulations
Solution Approach 1:
By consolidating multiple separate databases into one centralized database, the patent eliminates the need for multiple entities to independently manage and comply with regulations. A single entity can ensure unified regulatory compliance across all trial phases, reducing the overall compliance burden while maintaining independent database management capabilities.
3Adaptability or versatility
If a new database is built for each new digital therapeutics trial, then the database can be optimized for specific trial requirements, but it involves a substantial amount of time, effort, and cost
Solution Approach 1:
The centralized database is designed as a universal platform that can accommodate multiple digital therapeutics trials with different requirements. It provides a standardized framework for data collection, storage, and correlation that can be configured for specific trial needs without requiring complete database reconstruction, thereby reducing setup time and cost while maintaining trial-specific optimization.
4Adaptability or versatility
If new databases are created for each new trial, then data can be collected according to trial-specific schemas, but data must be duplicated for each database causing unnecessary duplication of data and increased storage usage
Solution Approach 1:
The patent merges data collection into a single centralized database with a unified schema that can accommodate data from multiple trials. This eliminates the need to create and maintain multiple separate databases, thereby preventing data duplication while preserving the flexibility to collect trial-specific data through standardized fields and structured formats.
Data Source
AI summary
Provided herein are systems and methods of managing access to data associated with trials for digital therapeutics on participants. One or more processors can maintain a data lake for a plurality of phases associated with a trial for a digital therapeutic on participants. The data lake may a plurality of datasets corresponding to at least one of the plurality of phases. The one or more processors can receive, from a user device, a request corresponding with at least one of a participant or group of participants, an endpoint, and a phase of the plurality of phases corresponding with accessing the plurality of datasets. The one or more processors can select a corresponding portion of the plurality of datasets based on the request to provide the user device.