Hash-Based eCOA Validation for Clinical Trial Reuse
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Solution Overview
Problem
The development and testing of electronic clinical trial outcomes assessments (eCOAs) are time-consuming and resource-intensive, hindering efficient clinical trial building.
Innovation Solution
A hashing-based method for validating eCOAs, which involves obtaining an initial hash value from a pre-built assessment, hashing the assessment files to generate a second hash value, and validating the eCOA if the second hash value matches the initial hash value.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If full validation and testing of eCOA assessments is performed each time, then reliability and data quality are ensured, but development time and resources are significantly consumed
Solution Approach 1:
The patent performs validation and generates hash values for eCOA assessments in advance during the build process. The pre-built assessments are validated beforehand and their hash values are stored. During clinical trial execution, these pre-validated assessments with stored hash values are reused without repeating the full validation process, thus ensuring reliability while reducing time consumption.
Solution Approach 2:
The patent creates copies of pre-built eCOA assessments and their associated hash values. Instead of re-validating the original assessments each time, the system copies the validated assessments and verifies their integrity by comparing hash values. This copying mechanism allows rapid reuse of validated assessments across multiple clinical trials without repeating the validation process.
2Reliability
If comprehensive testing of eCOA assessments is conducted, then data quality and compliance are improved, but resource consumption increases
Solution Approach 1:
The system performs comprehensive validation and resource-intensive testing in advance during the build phase. The hash values generated from this comprehensive validation are stored and reused. During actual clinical trial execution, only lightweight hash value comparisons are performed, dramatically reducing resource consumption while maintaining data quality through the previously performed comprehensive validation.
Solution Approach 2:
The patent copies pre-validated assessments and their hash values for reuse. The expensive comprehensive validation is performed once on the original, and subsequent copies are verified through efficient hash comparison. This approach maintains data quality standards while minimizing resource consumption during repeated usage across multiple trials.
3Adaptability or versatility
If eCOA assessments are re-built for each clinical trial, then adaptability to specific trial needs is achieved, but development efficiency decreases
Solution Approach 1:
The patent pre-buids eCOA assessments during the build process with their hash values calculated and stored. These pre-built assessments can be quickly copied and deployed to multiple clinical trials without re-building. The system maintains productivity by reusing these pre-built assessments while still allowing adaptability through selective copying and deployment to different trial contexts.
Solution Approach 2:
The patent creates universal pre-built eCOA assessments that can serve multiple clinical trials. By validating assessments once and storing their hash values, the same validated assessment can be copied and used across different trials, achieving multi-functionality. This universal approach improves productivity while maintaining adaptability through the flexibility of copying assessments to where they are needed.
Data Source
AI summary
The present disclosure is related to systems and methods for hashing-based assessment of electronic clinical trial outcomes. Such systems and methods may advantageously enable secure, rapid, efficient, and cost-effective reuse of pre-built eCOA assessments for clinical trials. In an aspect, the present disclosure provides a computer-implemented method for validation of an electronic clinical trial outcome assessment (eCOA), comprising: (a) obtaining an assessment of an eCOA, the assessment comprising a plurality of files generated by performing a first validation of the eCOA; (b) obtaining a first hash value associated with the assessment of the eCOA, the first hash value generated by hashing the plurality of files of the assessment of the eCOA; (c) hashing the plurality of files of the assessment of the eCOA to generate a second hash value; and (d) validating the eCOA when the second hash value is equal to the first hash value.