Centralized Data Lake for Digital Therapeutics Trial Coordination
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Solution Overview
Problem
Current approaches for managing data in digital therapeutics trials face challenges such as separate databases for pre-trial, clinical trial, and post-trial phases that lack communication, leading to difficulties in correlating data, inefficient data integration, and unnecessary duplication, which increases costs and user confusion.
Innovation Solution
A centralized data storage system, or data lake, integrates data across all phases of a trial, allowing easy correlation and integration of data from multiple trials, reducing duplication and providing a unified user interface for managing multiple digital therapeutics trials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If separate databases are used for pre-trial, clinical trial, and post-trial phases, then data can be collected and stored for each phase, but data correlation and integration become difficult and require additional effort
Solution Approach 1:
The patent merges pre-trial, clinical trial, and post-trial databases into a single centralized database structure. This allows all trial phase data to be stored in one location, enabling easy correlation and integration of data across phases without requiring complex inter-database communication or additional manual effort to bridge separate systems.
2Ease of manufacture
If separate databases are maintained by separate entities in separate locations, then each database can be independently managed, but communication and data correlation between phases are lost
Solution Approach 1:
The patent segments data by trial phase within the centralized database using distinct data tables or sections for pre-trial, clinical trial, and post-trial data. This segmentation allows each phase's data to be independently managed and accessed while maintaining the ability to correlate information across phases through unified participant identification and linked records.
3Adaptability or versatility
If a new database is built for each new digital therapeutics trial, then the trial-specific data structure can be optimized, but time, effort, and cost increase substantially
Solution Approach 1:
The patent creates a universal centralized database framework that can accommodate multiple digital therapeutics trials with different specific requirements. The standardized structure includes common fields and tables that work across all trials, while allowing trial-specific customization through configurable parameters and optional tables, eliminating the need to build entirely new databases for each trial.
4Adaptability or versatility
If multiple separate databases are used across trials, then each database can be independently configured, but data duplication occurs and storage requirements increase
Solution Approach 1:
The patent merges duplicate data entries into a single centralized database, ensuring that participant information, trial data, and outcome measures are stored only once regardless of which trial phase or specific trial they belong to. This eliminates redundant data storage while maintaining the ability to access and configure data according to different trial requirements through unified query interfaces.
Data Source
AI summary
Provided herein are systems and methods of managing access to data associated with trials for digital therapeutics on participants. A server can maintain a data storage for a plurality of phases associated with a trial for a digital therapeutic on participants. The data storage may include (i) a first portion of a plurality of datasets from the plurality of participants from one or more of the plurality of phases of the trial, and (ii) a second portion of the plurality of datasets from the digital therapeutics in at least one of the plurality of phases of the trial. The server can receive from a user device, a request identifying a phase of the plurality of phases for which the plurality of datasets is to be accessed. The server can select a corresponding portion of the plurality of datasets based on the request to provide the user device.