Getting the Most out of IRT: What Really Makes the Difference for RTSM

When considering Interactive Response Technology (IRT), many think only about its base functionality – ensuring effective randomization and trial supply management (RTSM) while maintaining the blind during clinical trials. However, today, these critical functions have become a baseline for what the industry expects of this technology.

Since its inception over three decades ago, IRT has evolved to meet the ever-changing needs of the clinical development industry. Gone are the days of IRT only being used for basic RTSM functions in large, late-phase trials. Today, IRT is frequently relied on to:

• Support Phase I trials
• Accommodate all trial designs, including cohort and  adaptive/platform trials
• Perform complex calculations and logic as per complex protocols

Clinical trial sponsors also expect more from the people behind their IRT solutions. A reliable IRT vendor should act as a partner and provide expert advice and guidance about the proper and efficient implementation of their IRT system. They should work to understand and analyze each study’s unique requirements and develop a strategy to meet the trial’s goals, identify and mitigate risks, and allow flexibility for the future.

Here we present specific examples of what an advanced IRT system and the people behind it can deliver, beyond the basic expectations of RTSM.

Randomization

Using an IRT for randomization functionality not only helps to ensure data and study integrity by eliminating bias, but it also manages the risks of randomization imbalance.

Randomization and Beyond

Although blocked randomization is the methodology used for most clinical trials, IRT systems are increasingly being used to accommodate highly complex dynamic allocation methods. For example, minimization helps reduce imbalances across treatment arms while considering prognostic factors such as disease stage.

An advanced IRT can be used to facilitate this and other equally complex dynamic allocation methods, such as Zelen’s, hierarchical dynamic, Urn methods, and Bayesian response. Adaptive and platform studies can also be supported. You should be able to rely on your IRT vendor to provide expert guidance on the most appropriate methodology to meet your study’s randomization needs.