Clinical Trial Participant Matching via Interface Terminology
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Solution Overview
Problem
The process of identifying potential participants for clinical trials is inefficient due to the complexity of trial protocols, extensive extraneous information, and the use of free text for inclusion and exclusion criteria, leading to delays and inefficiencies in recruiting suitable participants.
Innovation Solution
A method and system that normalize and structure clinical trial and patient data using interface terminology, allowing for accurate matching of participants by mapping inclusion and exclusion criteria to a database of electronic health records, thereby improving the efficiency and accuracy of participant identification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If free text is used to record inclusion and exclusion criteria, then flexibility in documenting trial protocols is improved, but data retrieval and processing efficiency deteriorates
Solution Approach 1:
The patent transforms the state of inclusion and exclusion criteria from free text format to structured coded format. This parameter change enables both flexibility (through selectable codes) and efficiency (through machine-readable structure), resolving the contradiction between adaptability and productivity.
Solution Approach 2:
The patent introduces an intermediary coding system that acts as a mediator between the flexible documentation needs and the efficient retrieval requirements. These codes serve as a bridge, allowing human-readable flexibility while enabling machine-efficient processing and retrieval.
2Loss of information
If extensive extraneous information is included in trial database records, then completeness of trial protocol documentation is improved, but data processing complexity and time deteriorates
Solution Approach 1:
The patent segments trial protocol information into distinct structured categories (inclusion criteria, exclusion criteria, intervention details, etc.). This segmentation allows the system to process only relevant segments when matching participants, reducing processing time while maintaining complete documentation of all trial aspects.
Solution Approach 2:
The patent extracts key matching criteria from the extensive trial protocol information and places them into structured, easily accessible fields. This extraction enables rapid processing of essential matching parameters while the complete protocol remains documented but not actively processed during matching operations.
3Extent of automation
If natural language processing is used to retrieve inclusion and exclusion criteria, then automation of data retrieval is improved, but accuracy in identifying potential trial participants deteriorates
Solution Approach 1:
The patent performs preliminary structuring and coding of inclusion and exclusion criteria during data entry, before the matching process begins. This preliminary action creates a foundation of structured, accurate data that enables both high automation in retrieval and high precision in participant identification, eliminating the need for less accurate NLP processing.
Data Source
AI summary
A computer-implemented system and method for identifying potential clinical trial participants from one or more databases of patient electronic health information includes analyzing the clinical trial requirements and mapping those requirements to an interface terminology, where concepts of the interface terminology include a key concept and a group of one or more additional concepts that are related in the context of the clinical trial. The method further includes mapping the patient electronic health information to the interface terminology, building a query of one or more interface terminology elements; analyzing the patient health information for matches to the one or more interface terminology elements and, if necessary, iterating the process by adding additional interface terminology elements to the query.