How Does an IRT System Work?
How Does an IRT System Work?
Interactive Response Technology (IRT) is proving invaluable to trial investigators in managing participant logistics and drug supply in clinical trials.
Not only can IRT be a huge advantage for participant enrollment and randomization in studies, but it is also used to optimize supply chain management, ensure data quality, and improve data access.
How does an IRT system work? That’s what we will discuss in this article, which looks individually at IRT functions of randomization, participant management, and drug supply management, as well as reporting and analysis.
Randomization
Favored by clinical researchers, randomized clinical trials allocate participants to a treatment arm according to a random mechanism.
With its ability to negate treatment arm bias, IRT is at the core of randomization for clinical trials. IRT systems have the ability to run the randomization scheme, which helps to eliminate bias and the potential for human error.
The randomization process in an IRT system takes into account multiple critical factors to ensure appropriate participant allocation, including; eligibility criteria, stratification based on specific participant characteristics, and complex algorithmic assignment to treatment groups.
Complex randomization algorithms consider numerous variables that might include:
– participant demographics
– medical history
– disease stage
– previous treatments
– specific study protocol requirements
By implementing these sophisticated randomization techniques, researchers can create balanced study groups that provide more reliable and meaningful research outcomes.
Maintaining blind protection
IRT can also maintain blind protection in a clinical trial, reducing bias in randomized trials.
Blind protection ensures that any blinded role in a clinical trial is unaware of treatment assignments.
Participant management
Participant management is a component of the IRT system that includes participant enrolment, engagement, and tracking throughout a clinical trial.
The participant management features of an IRT system typically include:
– Initial participant screening and enrolment
– Comprehensive participant information management
– Real-time tracking of participant progress
– Integration with electronic participant-reported outcome (ePRO) technologies
– Monitoring of participant compliance and study participation
– Study visit scheduling
IRT integrates seamlessly with EDC, sharing necessary participant data, reducing the potential for human error, reducing data discrepancies, and making participant information readily accessible to authorized personnel.
Drug supply management
Supply chain management is one of the most complex logistical challenges within clinical trials. IRT provides comprehensive tracking and management of investigational medical products (IMP) throughout the entire clinical trial process.
Using the centralized platform provided by IRT, shipments to trial sites can be managed automatically, or ordered manually when required. After shipments arrive, IRT offers management of the trial site’s inventory as well as precise drug allocation to specific participants. Some IRT systems also allow the monitoring of drug expiration and storage conditions.
With the intelligent, automated drug supply management capabilities offered by IRT, resources can be used more efficiently in clinical trials and the potential for human error can be reduced.
Reporting and analysis
The reporting and analysis capabilities of IRT systems are powerful. This provides trial investigators with real-time insights upon which to base informed decisions throughout the clinical trial.
Among the reporting and analysis features offered by IRT are:
– Comprehensive data collection across multiple study parameters
– Real-time monitoring and tracking of trial progress
– Customizable reporting interfaces
– Advanced data visualization tools
– Integration with other clinical research platforms
Using IRT, researchers can access a wealth of up-to-the-minute information including; participant enrolment rates, randomization distribution, drug supply status, and emerging trial trends.
Study management
The ability to conduct real-time analysis is especially important for adaptive clinical trial designs, where study protocols might need to be modified based on emerging data.
In these cases, IRT systems provide the flexibility and insight necessary to make informed decisions and respond to study changes, preparing for both the expected and unexpected.
IRT: Meeting the evolving demands of clinical trials
In supporting management of studies, sites and subjects; IRT continues to help researchers reduce risks, conducting more efficient, precise, and reliable clinical trials. The ability to customize IRT systems to best meet the requirements of each study and protocol has made advanced IRT solutions indispensable for trial investigators tackling today’s study complexities.
As clinical research evolves, IRT systems look set to be invaluable in investigating new treatments and medical interventions. Perceptive eClinical’s RTSM is at the forefront; offering a reliable and adaptable platform which can help to effectively randomize, optimize inventory and improve planning.
Learn more about innovative IRT solutions from Perceptive eClinical, or contact our Solutions Specialist directly
