Reconciliation-Free IRT

IRT Essentials

One of the questions most frequently asked by clients during demos of the Veracity Logic IRT (IVR/IWR) system is how best to handle the problem of having to reconcile data between a study’s IRT and EDC platforms.

The answer is twofold, but simple: First, move data between the two systems in only one direction. Second, set up your study so you don’t duplicate data in the two systems.

Electronic integration between the IRT and the EDC systems should be a one-way arrow – ideally, data should be ‘pushed’ from the IRT to the EDC. Not only is this cheaper than requiring a two-way transfer of data (i.e., also ‘pulling’ from the EDC into the IRT, which can double costs), but, depending on the EDC platform being used, it may also be technologically simpler, since EDC APIs to receive data may be more available than APIs to push data.

Four Ways to Reduce IRT Help Desk Calls

IRT Essentials

It’s essential to have a strong 24/7 Help Desk backing up your IRT vendor. But be sure the IRT system you’re choosing also has a sufficient array of ‘do it yourself’ options that will empower your study team to safely do system updates and save time and money by acting independently of the Help Desk.
Here are just four ways to reduce the need for vendor intervention:
1. Look for a system with a login screen that enables users who’ve forgotten (lost) their passwords to simply request a temporary credential to be sent to their email, without having to contact the Help Desk. This is the one item that most directly reduces the amount of Help Desk involvement!

Strata Versus Cohort: A Clarification

IRT Essentials

We’ve seen confusion in recent IRT (IVR/IWR) RFPs and study protocols in the use of ‘strata’ and ‘cohort’ when describing desired approaches to randomization. The words are often used in opposition – that is, one is often specified when it’s really the other that’s required.
This confusion in terminology can negatively impact the bidding timeframe, requiring back and forth clarification between vendor and sponsor, or worse yet, can wrongly inflate or deflate the final bid tally. Correcting after the fact also takes additional time. Better by far to specify the strata or cohort requirements correctly from the outset

How to Get a 2 Week IRT Rollout: Re-Inventing the URS

IRT Essentials

One of the things we try to do with our weekly hot topics is bring to the forefront the latest excitements, ideas, and controversies surrounding clinical trials and Interactive Response Technology (IRT/IVR/IWR).

Among the most hopeful initiatives touted in recent industry conferences is the goal of implementing a 2 week rollout for an IRT system, from Contract Approval to Release for Client Testing (UAT).

Smoke and mirrors? Pie in the sky?
Or is it actually feasible?

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.