What It Means to be Flexible

IRT Essentials

Companies providing IRT (IVRS/IWRS) systems that support clinical trials know they must be seen as being “flexible” in their approach to delivering those systems. Most IRT vendors claim a capacity for flexibility. But what does that actually mean…and how should one expect flexibility to impact cost and timelines?

Name That App

IRT Essentials

In November 2016 we developed a post called, “Acronym for This, Acronym for That.” In it we talked about the various names used to describe clinical IRT (IVR/IWR) systems over time.

Clinical IRTs started life as Interactive Voice Response (IVR) systems. These systems allowed users to enter clinical data over the telephone. Functions were limited by what could be done via a touchtone interface. Typically, this was limited to recording subject activities, receiving shipments, and unbinding subjects.

Later, the industry graduated to Interactive Web Response (IWR) systems. These continue to have much greater scope in the functions available to users, and the ability to edit information using free text make the systems robust and user-friendly. Phone is still available for a select set of functions.

The term “IRT” – meaning Interactive Response Technology – came into use because most modern systems can now do both – IVR and IWR.

The argument against with these acronyms, however, is that they describe the technical basis of the tool, not the functions (purposes) that the systems are designed to address.

A good example of a functional approach to naming systems is the Clinical Trial Management System (CTMS). The name, CTMS, describes the function of the system – whether the technical platform is a standalone desktop program, an iPhone app, or a web-based application, the function of a CTMS is just what the name says: to allow clinical overseers to manage their clinical trial.

The function of a clinical IRT is to handle multiple aspects of subject management – e.g., screening, randomization, subsequent drug assignments, screen failures, withdrawals and unblindings, etc. – and multiple aspects of clinical trial materials management – e.g., requesting shipments, sending shipments, receiving shipments, applying sophisticated drug assignment options, and so on. What, then, is a good name for such a system?

A new acronym now being tossed around is RTSM. It stands for Randomization &Trial Supply Management. This at least attempts to describe IRT systems on a functional basis but it misses the boat. It doesn’t go far enough. As noted above, IRT systems do a lot more than just randomization when it comes to subject management.

If we were going to join the naming frenzy, Veracity Logic might invent a name like SMARTS which stands for Subject Management & Randomization & Trial Supply management. SMARTS at least provides some indication of the full variety of functions available in an IRT system.

That said, we at Veracity Logic don’t want to join the naming frenzy.

For one thing, we’ve had multiple clients ask us to please describe the functional difference between the role of an RTSM and an IRT. Answer: There is none.

What new acronyms do create if they don’t have a true functional difference underlying them is a whole lot of confusion. In some cases, they are the result of marketing strategies: an attempt to infer a new level of service and/or the appearance of a cutting edge advantage.

Veracity Logic will not be developing new acronyms for our product. We will stick with the tried and true acronym, Clinical IRT (IVR/IWR). IVR has a 25-year history. IWR has a 15-year history. Both of these legacy acronyms are understood by Sponsors and CROs for the functions that they fulfill.

And the time we save not inventing new acronyms, we can use to create new ways to deliver user-friendly, configurable, intuitive systems that ease the workload for our clients and users by providing great power under the hood.

We don’t call that old fashioned.

How to Choose an IRT for Your Clinical Trial (Revised)

White Papers

Interactive Response Technology (IRT) is the currently accepted term for clinical IVR (Interactive Voice Response) and IWR (Interactive Web Response) systems used in clinical trials. Today’s IRT platforms provide complex subject/activity management functionality and robust management of drug supply and shipping throughout the trial.

While IRT technology has gotten increasingly powerful, detailed knowledge of all the functions an IRT can and should do has lagged somewhat behind. This white paper — which includes an up-to-date checklist for use in the IRT selection process — was prompted by requests from our clients and colleagues —Sponsors, CROs, and Clinical Suppliers— for a reasonably comprehensive summary of features and issues to consider when vetting IRT systems today. The first iteration of the white paper/checklist was published in 2016.

Using Smaller, Specialized Companies for Clinical Trials

IRT Essentials

One of the recurring themes at a recent Chicago conference of pharmaceutical professionals was the industry’s shift from a longstanding outsourcing model of searching for a ‘one stop shop’ to a new model which favors employing a horizontal spread of uni-task experts to specifically target the diverse needs of a clinical trial.

“The success and wisdom of the new approach speaks for itself,” says David Goldston, Managing Director of Veracity Logic, an IRT (IWR/IVR) provider. “We obviously agree with Sponsors who say ‘Let’s look for solid expertise, and let’s nudge our project management strategy to encompass multiple inputs’. This approach stands to provide a greater return in the areas that matter most: quality, efficiency, reliability…and, often, economics.”

Putting Study Control Where It Belongs

IRT Essentials

“Patient-centric clinical trials” is a hot topic in the pharmaceutical industry today.

To be “patient-centric” is to consider in a new way the needs and realities of the patient experience, and to allow that understanding to inform your clinical trial all the way from study design through final visit.

The idea itself is simple — to proceed in a manner that is informed from the outset by what works and doesn’t work best for the patient (as opposed to the makers-of-protocols). The goal is to reduce dropout rates, to increase feasibility, and enhance patient satisfaction. By essentially shifting “power” to the patient, the potential for successful execution of a clinical trial is dramatically increased.