Variable Dose Drug Delivery Device for Adaptive Clinical Trials
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Solution Overview
Problem
Current clinical trials face challenges in managing variable drug doses during adaptive clinical trials, leading to increased drug supply needs, complex blinding procedures, and inefficiencies in data capture and patient adherence, particularly with traditional fixed-dose drug delivery devices that are not easily integrated with internet communication for real-time data collection.
Innovation Solution
The use of variable dose drug delivery devices, such as autoinjectors and infusors, that can deliver multiple doses and integrate with RFID or NFC technology for real-time data communication, allowing for dynamic dose adjustment and improved patient adherence, while simplifying clinical trial manufacturing and blinding processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If traditional fixed-dose drug delivery devices are used in adaptive clinical trials, then blinding procedures become complex and drug supply quantities increase significantly, but device simplicity and ease of manufacture are maintained
Solution Approach 1:
The drug delivery device is designed with variable dose delivery capability, allowing the dose to be dynamically adjusted based on patient response and trial progression. The device can deliver different doses (e.g., 0.5mL, 1.0mL, 1.5mL) from the same device platform, enabling adaptive trial designs without requiring multiple different device types or complex blinding procedures for different dosages.
Solution Approach 2:
A single universal drug delivery device platform is designed to handle multiple dose levels and trial conditions. The device can function as both a treatment delivery system and a data collection system, integrating RFID/NFC technology for real-time data capture. This multi-functionality eliminates the need for separate devices for different dosages, simplifying blinding procedures while maintaining adaptive trial flexibility.
2Adaptability or versatility
If all patients are prepared to receive all different doses in adaptive clinical trials, then adaptability to trial changes is improved, but drug supply quantity and material wastage increase significantly
Solution Approach 1:
The system dynamically adjusts the dose delivered to each patient based on real-time trial data and individual patient response. The variable dose capability allows the trial to adapt to accumulating data without requiring pre-preparation of all possible dose combinations for all patients, thereby reducing the total drug supply quantity needed while maintaining full adaptability.
Solution Approach 2:
The drug delivery device incorporates RFID or NFC technology that enables automatic data capture and transmission when the device is used. This self-service data collection system provides real-time information on dose administration and patient response, allowing the trial to adapt dynamically without manual data entry and enabling more efficient drug supply management.
3Productivity
If real-time data collection from patients is implemented, then data quality and trial efficiency are improved, but system complexity and data processing requirements increase
Solution Approach 1:
The drug delivery device automatically captures and transmits data when used, eliminating the need for manual data entry by patients or healthcare providers. The RFID or NFC technology enables seamless communication between the device and the trial system, automatically recording dose information, timing, and patient response data. This self-service approach improves data collection efficiency while keeping the system relatively simple by leveraging existing wireless communication technologies.
Solution Approach 2:
The system implements real-time feedback loops where data from drug administration is immediately captured and transmitted to the trial system. This feedback mechanism allows for immediate analysis and adjustment of trial parameters, improving productivity by enabling rapid decision-making. The feedback system is kept simple by using standardized RFID/NFC communication protocols that integrate easily with existing trial management systems.
Data Source
AI summary
The method set out herein involves conducting adaptive clinical trial to develop parenteral therapeutic product with variable dose drug delivery devices. The method comprises using a variable dose drug delivery device to respond modifications during the adaptive clinical trial, wherein the variable dose drug delivery device is able to deliver more than one dose level and is for delivering fluid formulation. Other methods set out herein involve using a variable dose drug delivery device equipped with radio frequency identification (RFID) or near field communication (NFC) technology to improve patient adherence to drug administration in the adaptive clinical trial.