Clinical Trial Candidate Screening Using Structured Medical Data
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Solution Overview
Problem
Existing methods for selecting clinical trial candidates are inefficient, requiring substantial manual work and are inaccurate in determining eligibility, leading to delays and increased costs due to the inability to accurately predict the number of eligible patients, especially in therapeutic trials that require a large number of subjects.
Innovation Solution
A method and system that utilizes a structured medical examination data integrated management database to convert eligibility and exclusion criteria into searchable words, allowing for efficient screening of candidates by searching patient information directly, reducing the workload on physicians and coordinators.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If manual screening of patients against eligibility criteria is performed, then accuracy in determining eligibility is improved, but time consumption and workload increase substantially
Solution Approach 1:
The patent replaces the manual mechanical review process with an automated computer-based system that retrieves patient data from databases and automatically compares it against eligibility criteria. The system generates automated screening reports that identify eligible patients, eliminating the need for manual document review while maintaining accuracy through systematic data comparison.
Solution Approach 2:
The patent introduces an automated screening system as an intermediary between patient data and eligibility determination. This system acts as a mediator that retrieves data from multiple sources, processes it against predefined criteria, and presents results to researchers, thereby reducing direct human effort while preserving decision accuracy.
2Reliability
If detailed eligibility and exclusion criteria are established, then trial quality and subject appropriateness are improved, but the complexity of screening increases
Solution Approach 1:
The patent divides complex eligibility criteria into discrete, searchable data elements that can be systematically evaluated. The system segments patient data into comparable fields and evaluates each criterion independently, then integrates results to determine overall eligibility, making the complex screening process manageable and automated.
Solution Approach 2:
The patent transforms qualitative eligibility criteria into quantifiable parameters that can be automatically evaluated by the computer system. By converting screening criteria into structured data comparisons, the system maintains the rigor of detailed criteria while enabling automated processing through parameter-based evaluation.
3Productivity
If the number of patients to be screened is increased to meet trial enrollment targets, then trial completion probability is improved, but resource requirements and costs increase
Solution Approach 1:
The patent enables the screening system to automatically perform data retrieval, comparison, and eligibility determination without requiring proportional increases in human screening resources. The automated system processes large volumes of patient data efficiently, allowing enrollment targets to be met without linearly increasing staff or time resources.
4Measurement precision
If comprehensive patient data review is performed, then eligibility determination accuracy is improved, but the workload on physicians and coordinators increases
Solution Approach 1:
The patent extracts the burdensome manual review tasks from physicians and coordinators by automating data retrieval and comparison functions. The system extracts relevant patient data from databases, performs automated eligibility assessment, and presents results, leaving clinical professionals to focus only on final verification and patient communication.
Data Source
AI summary
Candidates for a clinical trial can be efficiently narrowed down by, after converting eligibility conditions and exclusion conditions of the clinical trial into search words, performing screening using a database in which structured medical examination data is stored. It is possible to provide a method and a system that select candidates for a clinical trial and a therapeutic trial more efficiently with less work.