Patient-Facing Trial Protocol Automation With Adaptive Alert Timing
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Solution Overview
Problem
Existing clinical trial systems are inefficient and prone to errors due to reliance on human effort for constructing protocols and monitoring patient behavior, which is time-consuming and costly.
Innovation Solution
A system and method for automatically constructing patient-facing protocols using wearables and sensors, incorporating AI engines to monitor patient behavior and adjust alerts or alarms based on individual patient data, with flexibility in protocol adherence.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If human effort is used to construct clinical trial protocols and monitor patient behavior, then flexibility and judgment can be applied, but the process is time-consuming and expensive
Solution Approach 1:
The patent replaces manual human construction and monitoring of clinical trial protocols with an automated computer system. The system automatically generates patient-facing protocols, monitors patient behavior through wearables and sensors, and adjusts alerts based on predefined criteria, eliminating the need for continuous human intervention while maintaining accuracy through algorithmic processing
Solution Approach 2:
The system performs self-monitoring and self-adjustment by automatically tracking patient compliance, analyzing wearable data, and modifying alert timing without requiring constant human oversight. The protocol management system autonomously evaluates patient behavior patterns and adjusts monitoring parameters based on predefined rules and machine learning models
2Loss of time
If automated systems are used to construct protocols, then time and cost are reduced, but flexibility in protocol adaptation is lost
Solution Approach 1:
The system incorporates dynamic adaptability by allowing automated protocol construction with built-in flexibility parameters. The automated system can adjust alert timing, modify monitoring parameters, and adapt protocol elements based on real-time patient data while maintaining the speed of automated generation, thus combining efficiency with adaptability
Solution Approach 2:
The patent enables parameter changes within automated protocols by allowing modification of timing parameters, alert thresholds, and monitoring frequencies based on patient-specific data patterns. The system maintains automated construction while permitting parameter adjustments to accommodate individual patient needs and evolving trial requirements
3Ease of manufacture
If basic software is used for patient interaction, then implementation is simple, but the system cannot analyze protocols for potential problems
Solution Approach 1:
The system achieves multi-functionality by integrating protocol construction, patient monitoring, behavior analysis, and problem detection into a single unified platform. The automated system not only generates protocols but also continuously analyzes them for potential issues, monitors compliance, and adjusts parameters, eliminating the need for separate basic software while adding comprehensive analytical capabilities
Data Source
AI summary
A system and method for automatically constructing patient-facing protocols from an initial clinical trial protocol design. The patient-facing protocols preferably include one or more wearables or other sensors (including sensors in the phone), for monitoring patient behaviors. The patient-facing protocols may also include one or more questions to be asked of the patient, for subject patient state information. Such a system is preferably able to both construct an effective patient-facing protocol for a clinical trial, including any aspects that may have at least some flexibility, such as for example a period of time during which a particular action may be taken. Such flexibility is preferably then automatically incorporated as the system monitors the behavior of each patient, for example by adjusting a time that an alert or alarm is sent to a particular patient within the permitted period on a daily, weekly, monthly or yearly basis, or according to any other permitted period of time.