Interactive Response Technology, or IRT, is a system used to automate supply management, randomization, and analytics for clinical trials. IRT ensures that participants receive the correct treatment at the correct time, allows for enhanced drug supply logistics tracking, and also provides the ability to obtain real-time data from subjects during the study duration.
Through the various automations that service provides, IRT can help improve efficiency, mitigate risks, and reduce costs in clinical studies.
Randomization for clinical trials
One of the primary functions of IRT is to randomize patients in a clinical trial. Once a site registers a patient into the IRT system, the IRT will randomize the patient into a treatment arm. These treatment arms are typically defined in the protocol and can range in number depending on the study design. Along with the treatment arm assignment, the system can indicate which drug unit(s) should be dispensed to the patient.
The purpose of randomization in a clinical trial is to reduce bias and create an even distribution of enrollment. This is particularly important in trials that are double-blind, where certain individuals, such as the patient and the primary investigator (PI), cannot be aware of the patient’s assigned treatment arm. The IRT system helps achieve this purpose by automating the process while adhering to the blind, which allows for a more efficient trial and helps mitigate risk of mis-randomization.
IRT is increasingly being used as a randomized controlled trial (RCT) tool because it allows for:
- Greater flexibility in study design, including the ability to use non-equivalent control groups with more participants per control group than usually allowed by traditional methods (e.g., cluster randomized trials).
- Minimal impact on multiple arms of the trial and its results (i.e., no additional cost or increase in variability).
Supply Management for clinical trials
The supply management function of IRT is used to manage inventory and shipping logistics. For this reason, IRT can also be referred to as Randomization and Trial Supply Management, or RTSM. The tool can be used to manage purchase orders, shipments to/from depot and sites, and drug returns, while adhering to country-specific shipping regulations. In addition, IRT allows for inventory tracking on a site and depot level, which provides sponsors a simple method of quickly monitoring inventory levels and status.
The tool also very helpful in managing forecasting and replenishment, which enables a clinical trial sponsor to provide clinical trial participants with the products they need at the right time. The IRT system can track active subjects as well as predict future enrollment patterns to ensure the site’s inventory has enough units to dispense to patients but not too many units to create drug wastage.
Analytics for clinical trials
Data analytics is the process of collecting and analyzing data to make business decisions. Clinical trial analytics are a subset of data analytics that focus on information generated during a clinical trial. IRT systems often offer comprehensive reporting options to contribute to the data analysis required to successfully conduct clinical trials, specifically when analyzing the effectiveness of a drug in relation to a particular treatment arm.
In this context, “data” means any information recorded by the clinical trial software system or collected from outside sources and stored in the system. Analytics software can analyze this data in many ways, but one common approach is to compare each participant’s baseline (pre-treatment) measurements with their later measurements. This helps researchers understand how treatment has affected participants as a whole, rather than just looking at individual results.
The main benefit of using clinical trial analytics software such as IRT is faster completion times for trials due to more efficient analysis methods: for example, it may take more time for an analyst to find out whether there were any adverse events among participants who received treatment A compared with those who received treatment B when using traditional manual methods rather than automation technology such as artificial intelligence (AI).
Conclusion
IRT is a system that automates supply management, randomization, and analytics for clinical trials. IRT can be used to manage the supply chain of clinical trials and eliminate the need for manual intervention by humans. It is a great tool for pharmaceutical and biotechnology companies looking to streamline operations in order to lower costs while improving efficiency at the same time.
