Interactive Response Technology
Interactive Response Technology
Interactive Response Technology, commonly known as IRT, refers in clinical trials to systems used in clinical trials for randomization and trial supply management.
Other commonly used names for the same technology include Randomization and Trial Supply Management System (RTSM) and Interactive Voice Response Systems (IVRS) and Interactive Web Response Systems (IWRS) .
IRT has proven a huge benefit to trial investigators and sponsors in managing the logistics of participant and drug supply throughout a clinical trial. In this article, we’ll discuss why IRT is used, how its data is collected, and the way it works in clinical trials.
Why use IRT?
Offering several features for managing participant dispensation and the drug supply chain, IRT affords clinical trials both control and flexibility.
The main benefits include:
– Automated processes – IRT systems offer automated processes for patient randomization (the process of randomly assigning patients to various groups with no accidental bias), eliminating the potential for human error
– Real-time monitoring – giving trial investigators an overarching view of clinical trials, informing decision-making with up-to-date data
– Clinical trial supply management – IRT vendors can offer tools from forecasting to site supply optimization. The automatic resupply of sites not only assures supply for visits, but it can also be tailored to meet specific goals and manage supply challenges.
How does IRT work in clinical trials?
The control and adaptability that IRT offers clinical trials include several key functions:
– Participant enrolment – IRT systems are used to screen potential participants for eligibility criteria ahead of, and during, clinical trials.
– Randomization – IRT can also perform randomization and allocate enrolled participants to treatment groups. This process randomly assigns participants to various groups with no accidental bias, ensuring they meet certain criteria and are allocated to the appropriate treatment arm.
– Blind protection – IRT can maintain the blind in a clinical trial, ensuring that one or more parties in a clinical trial are unaware of which treatment arms participants have been assigned to. IRT is also used to break the blind with immediate effect if required for pharmacovigilance or participant safety.
● Inventory and supply management – IRT allows participant supplies to be monitored; from initial batch release with expiry management, to shipments to sites, temperature management and destruction. Having a platform to track the allocation and distribution of investigational products reduces risks, and can also help to cut down waste of clinical supplies.
● Data collection – as we discussed earlier, IRT collects real-time data from study participants, including participant-reported outcomes such as symptoms and experience.
Data analysis
With IRT, trial investigators and sponsors have a secure, centralized platform to monitor the progress of their trials by collecting and analyzing data. This enables informed decisions to be based on up-to-date information thanks to real-time monitoring. Data analysis and real-time monitoring are particularly useful for adaptive trial designs, in which treatment protocols may need to be adjusted based on emerging data.
How is IRT data collected?
IRT systems enables data collection as per the protocol and study needs. The technology records information on trial participants, drug supplies, study logistics, and more.
All data collected in and calculated by the RTSM can be accessed by user-friendly interfaces
During clinical trials, data is collected in IRT in the following ways:
– Screening – IRT system users can record participant screening information, including name, date of birth, and key characteristics. Some IRT systems integrate with electronic participant-reported outcome (ePRO) and Electronic Clinical Outcome Assessment (eCOA) technology; this is a way for participants to self-report symptoms and outcomes related to a trial using devices such as smartphones and laptops.
– Randomization – based on the data collected, IRT systems will determine which treatment group to assign a participant to.
– Drug supply – IRT systems collect data on clinical trial drug supplies, managing and tracking the distribution of investigational drugs from central to local deports, to sites and to each trial participant.
– Data transfer – most clinical trials integrate IRT with Electronic Data Capture (EDC) systems designed to collect and store participant information. Data can be sent to or received from an EDC system, negating the need to re-enter it, thereby improving data integrity. IRT can be designed with integrations to reduce the effort of data reconciliation.
The key to seamless study management
As clinical trials become more complex – from being used to manage complex cohort management, to master protocol / platform designs, to personalized / precision medicine – IRT is proving to be indispensable.
Perceptive eClinical’s IRT / RTSM system improves clinical trial data quality, reduces error risk, and allows immediate changes to RTSM design. The control and adaptability its key functions provide is helping trial investigators and sponsors make informed decisions throughout the trial process; from set-up to implementation and data analysis.
Learn more about Perceptive eClinical’s RTSM solutions, or contact our Solutions Specialist today
