Portable Electronic Device for Clinical Endpoint Development
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Solution Overview
Problem
Clinical trials face challenges in reliably measuring subjective clinical trial endpoints, such as pain intensity, due to variability in patient responses influenced by environmental cues and interviewer biases, which affects the accuracy of medical product effectiveness assessments.
Innovation Solution
A method using portable electronic devices to administer and record patient responses to standardized questions, allowing for data analysis to develop and validate clinical trial endpoints, including patient-reported outcomes (PRO) data, to objectively assess treatment efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If standardized questions are administered by portable electronic devices, then measurement precision of clinical trial endpoints is improved, but device complexity increases
Solution Approach 1:
A portable electronic device serves as an intermediary between the interviewer and the patient, standardizing the administration of questions and recording responses. The device includes a processor that executes instructions to present questions, record answers, and control the interaction flow, thereby eliminating interviewer bias and environmental influences while maintaining manageable system complexity through modular design.
2Reliability
If patient responses are recorded by portable electronic devices, then reliability of clinical trial data is improved, but loss of information increases due to data transmission requirements
Solution Approach 1:
The portable electronic device incorporates feedback mechanisms that immediately confirm successful data recording and provide real-time validation of patient responses. The system includes procedures for verifying data integrity before transmission, and for detecting and correcting transmission errors, thereby maintaining high data reliability while minimizing information loss during data transfer to remote systems.
3Measurement precision
If environmental cues and interviewer biases are eliminated, then measurement precision is improved, but ease of operation decreases due to standardized procedures
Solution Approach 1:
The portable electronic device is designed to be self-sufficient in guiding the interaction, automatically presenting questions, recording responses, and managing the assessment workflow without requiring complex interviewer procedures. The device handles all standardized operations autonomously, reducing the operational burden on interviewers while maintaining high measurement precision through consistent, bias-free data collection.
Data Source
AI summary
A system for developing and producing clinical endpoints based on patient reported outcome data utilizing algorithms to generate decision rules to evaluate patient reported outcome type questionnaire is provided. The questionnaires can include health-related quality of life questionnaires and can predict the reliability of endpoints in supporting one or more medical labeling claims.