What is IRT? What is RTSM?

Evolution, Acronyms & Advances in Clinical Trials

In an industry so full of acronyms, no two are more often interchanged than IRT (Interactive Response Technology) and RTSM (Randomization and Trial Supply Management). Here we look at the system behind the letters, how over time, the terms have come to be used interchangeably, and how the technology is only one component of an effective RTSM solution.

The Evolution of IRT (or Do We Mean RTSM)

In our industry, an IRT system is a central piece of clinical trial execution that enables patient randomization and real-time drug allocation. Put simply, RTSM is the role of the IRT system. But it’s had different acronyms over the decades.

Looking back, some of us remember using 3-part, NCR paper forms for CRFs and the excessive effort that was needed for double data entry. Even once the first interactive voice response systems (IVRS) were introduced in the 1980s for randomizing patients over the phone, paper CRFs were still being used into the 1990s – including a short time when it wasn’t unusual to fax completed CRFs to get the data in faster.

Since the 2000s the internet has enabled the use of web-based systems, which were initially referred to as IWRS. This led to another, often-confusing term, IxRS, which was used to describe when study users could access the system both via the phone and the web.

Today, we’ve tossed the modality aside from the acronym and simply refer to IRT as the tool, or system, for delivering RTSM in clinical trials.

IRT’s Greatest Impact

Most would agree that IRT has delivered many benefits through the decades, but one of its greatest feats was separating randomization and drug supply into two distinct processes. Prior to IRT, randomization was built into the packaging. For example, a site would randomize a patient by selecting the lowest-numbered kit in their inventory. And this kit had all the drug intended for a patient throughout the entire study, which led to wastage in many forms.

Once IRT was established, the relationship between randomization and patient-specific supply packaging was severed. Kits could now be used for any patient, leading to a great reduction in wastage. This is perhaps the biggest impact IRT has had on clinical trials because it allowed for a more dynamic approach to both randomization and supply chain management, which we dig into deeper below.

Randomization: Putting the ‘R’ in RTSM

An IRT system ensures patients are randomized to the appropriate treatment arm and receive the correct medication throughout a clinical trial per the protocol.

Randomized clinical trials have long been considered the gold standard in clinical research. Using an IRT for randomization not only helps to eliminate bias to ensure data and study integrity, but it also manages the risks of randomization imbalance, or mis-dispensing, which can have implications for protocol compliance and patient safety.

If randomization is implemented incorrectly, the scientific integrity of the entire study could be called into question. However effective and reliable randomization requires more than just technology. Insight, expertise, and precise focus on the protocol’s needs are required to get randomization right, regardless of the protocol’s complexity.

Calyx’s wide range of fully validated randomization algorithms are configured to meet the needs of each individual study, and our proven IRT platform can be customized to any randomization algorithm, no matter how complex.

Trial Supply Management: Putting the ‘TSM’ in RTSM

IRT supports the challenging task of efficiently managing trial supplies/study drugs across global investigative sites, ensuring they have the right drug available for the right patient at the right time, every time.

At a minimum, an IRT must:

• Track study drug to the smallest unit throughout its journey from QP approval/release to patient allocation to destruction
• Manage the efficient supply of drugs  across global sites
• Manage expiry to remove the risk of medication expiring and interrupting patient treatment, which is especially challenging in oncology clinical trials
• Minimize unblinding risks to drive the integrity of the trial

But an advanced IRT can do so much more than this. Coupling the expertise of our RTSM specialists with robust standard and advanced inventory management approaches, Calyx IRT helps you:

Reduce your Effort

Calyx IRT reduces the burden of monitoring site stock against patient needs, automatically adapting a site’s stock to its recruitment rate.

Improve your Carbon Footprint

Calyx IRT supports all of your drug supply management aims, from limiting overage and keeping wastage to a minimum, to reducing the number of shipments raised.

Execute Complex Trial Designs

Over the decades, Calyx IRT has successfully supported a range of increasingly complex trial designs – including adaptive trials – across all therapeutic areas and phases.

Improve Trial Efficiencies

Calyx’s in-house expert statistical design and trial supply consultants can run a Supply Simulation to help sponsors make informed decisions about the optimal quantity of medication to produce for use in clinical development.

Regardless of the acronym, an IRT system is fundamental to the success of a clinical trial. As you consider your RTSM needs, make sure your IRT provider has the right people and a robust solution to drive your trial’s success.

At Calyx, our RTSM specialists leverage their combined 92 years of IRT experience to advise how to best implement trial designs and account for planned or unplanned situations. They lean on their vast experience and a system based on 30 years of evolution to deliver an optimal IRT solution based on a comprehensive understanding of your protocol, packaging plan, recruitment rates, and ongoing study needs.

The result? An adaptable, flexible, and reliable system ready to meet your trial’s current and future RTSM challenges.