Actionable Intelligence from the IRT for CRAs

IRT Essentials

One of the hottest topics in the clinical trials industry today is the transition to Risk Based Monitoring (RBM) (see Guidance for Industry: Oversight of Clinical Investigations_ A Risk-Based Approach to Monitoring; and ICH E6 R2). RBM includes the addition of a new ‘centralized monitoring’ function which focuses on risk within and across sites and even across projects, data that is then bundled to inform CRA activities.

But the industry is in transition: the vast majority of clinical trials are still not integrated with RBM processes. Project Managers and CRAs must still rely on IRT and EDC platforms to accomplish the kind of ‘pre-RBM’ remote monitoring within a project that mitigates risk and helps determine where site visits are needed and the level/type of SDV activities required.

In the News: An Overview

IRT Essentials

At three recent clinical trial conferences, industry thought-leaders laid out their current prospectus for revolutionary redesigns of traditional clinical trials processes – in many cases (but not all), leveraging technological advances in the interest of new concepts and efficiencies.

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.

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.

Hey, Do You Guys Do Many Phase 3’s?

IRT Essentials

We’ve recently had a few prospective clients ask us to add to our company’s introductory materials a couple of additional details about the project structure and client base of our Interactive Response Technology (IRT/IWR/IVR) – specifically, client type and project phase.

To that end, we’ve drawn together two key metrics that will let customers know at a glance the total project experience landscape here at Veracity Logic. We thought we’d share these today with you, our website/blog/newsletter readers!

Drumroll!

Client Base: About 50/50 split between CROs and Sponsors, on average. Company sizes range from small to large.
Project Types over the past decade of global IRT systems deployment:
52% Phase 3-4
48% Phase 1-2b
Veracity Logic is known in the industry to be a solid, economical option for smaller studies, and a user-friendly, flexible, robust environment (still economical!) for big studies. And, in a recent survey, many of our clients went out of their way to give major kudos to the VL project team for responsiveness, knowledge, and ability to adapt.

A Cautionary Tale: Configurability and Real Life

IRT Essentials

“Configurable” is a much bandied term these days when folks in the clinical trials industry get together to talk about technological support systems like IRT (IWR/IVR).

A configurable system is taken to mean “a state of being that is the opposite of custom-coded”. In other words, faster, cheaper, easier to adapt; changes that can be made with the click of a button rather than requiring two days of coding. In its most honest form, a system designed with an eye toward configurability is a must-have leap forward from a custom-coded system. It should be the first cut on any procurement checklist for vetting an IRT.

But, realistically, that’s where the wish list stops.

What a ‘configured system’ is not is a one-size-fits-all magic bullet. And yet all too often that’s the expectation… and the cause of inevitable frustration.

Revisiting Efficiency: How to Integrate your IRT with EDC

IRT Essentials

The Issue:

One of the most consistent questions we get from prospective clients is how best to handle data integration between the IRT and EDC systems being used for a clinical trial.

The EDC system will house the bulk of the clinical data, while the IRT is needed for randomization and drug assignment. What’s the most efficient, cost-effective way to accomplish two key study goals: to achieve integrated data in real time, and to avoid time-wasting duplication and reconciliation requirements between systems?

AGILE or Not – The Team Makes the Difference

IRT Essentials, Newsletter Archive

We’ve been surprised over the past year or so by the number of IRT companies that have begun touting AGILE methodology as the knight-on-a-white-horse come to save us all from our clinical trial timing dilemmas. Oh, if only it were that simple!
A Decade of Agility

Veracity Logic has been using an AGILE-style methodology for nearly 10 years now. What we have learned is this: In its cleanest form, the approach does allow project teams to implement systems faster than with the traditional waterfall. But — unfortunately for all of us – an AGILE process is not what finally makes a difference in the timelines of a project.