Master Clinical Database for Cross-Site Data Correlation
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Solution Overview
Problem
Clinical trials face significant challenges in coordinating data from various sources across different trials and sponsors, leading to laborious and repetitive tasks in site and investigator selection, as well as inefficient data coordination, which increases operational costs.
Innovation Solution
A master database generator system that collects and correlates data from disparate sources, including public and private databases, to create a comprehensive database of sites, site personnel, and subject information, facilitating site selection, patient tracking, and data mining, while engaging physicians and sponsors in collaboration to improve study protocols and reduce unnecessary amendments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If data from various sources across different clinical trials and sponsors is coordinated manually, then data coordination can be achieved, but the process becomes laborious and repetitive, increasing operational costs
Solution Approach 1:
The patent merges data from multiple disparate sources including public databases, private databases, and user-generated data into a single master database. This consolidation eliminates the need to manually coordinate data across multiple systems, directly resolving the technical contradiction by improving data coordination efficiency while reducing the time required for site and investigator selection.
Solution Approach 2:
The master database acts as an intermediary system that facilitates coordination between different clinical trials and sponsors. Rather than manually coordinating data between multiple parties, the database serves as a central mediator that automatically integrates and manages information, thereby improving productivity and reducing coordination time.
2Productivity
If a comprehensive database of sites and investigators is maintained, then site selection becomes more efficient, but the complexity of data collection and correlation from multiple sources increases
Solution Approach 1:
The master database is designed as a universal system that handles multiple functions: collecting data from public sources, private sources, and user inputs; correlating information across different trials; and supporting various selection criteria. This multi-functionality improves site selection efficiency while managing complexity through a single integrated system rather than multiple separate tools.
Solution Approach 2:
The patent segments data collection into distinct modules: public database interfaces, private database connections, and user input mechanisms. Each segment handles specific data sources independently, then the master database correlates them systematically. This segmentation reduces the perceived complexity by organizing data collection into manageable, specialized components.
3Loss of energy
If remote monitoring is used instead of physical site visits, then operational costs are reduced, but the ability to confirm adherence to trial design and good clinical practice may be compromised
Solution Approach 1:
The master database implements feedback mechanisms where site data is continuously collected, correlated, and analyzed. This feedback loop enables remote monitoring to effectively verify adherence to trial design and good clinical practice by systematically tracking and reviewing site activities, maintaining reliability while reducing operational costs compared to physical visits.
Solution Approach 2:
The patent replaces the mechanical system of physical site visits with an information-based system using the master database for remote monitoring. Data from sites is electronically captured and correlated in the database, substituting physical presence with automated data collection and analysis, thereby reducing operational costs while maintaining verification capability.
Data Source
AI summary
A method and system for generating a master clinical database from disparate sources, including public databases, private databases, and data from users, correlating the received data, determining a degree of confidence in and requesting and seeking confirmation of any data matched from the correlated data. The invention may identify key time points and users from whom to seek and receive confirmation of correlated data. The invention may be utilized to create a cross-trial, cross-sponsor, clinical master database that maintains appropriate user, subject and data confidentiality and privacy and which may be utilized to facilitate study design collaboration.