When NOT to use an IRT

IRT Essentials

As a dedicated IRT provider for more than a decade, Veracity Logic has deployed many systems for subject randomization, subject management, and management of study drug for all phases of clinical trials, including numerous Phase 1,1b, and 2 exploratory trials.

But a lingering conundrum in the industry with regard to these smaller studies is this: At what point does it stop making sense, in terms of per patient cost and savings in manual effort, to use an IRT system at all?

We help clients sort out the pros and cons of this question before irreversible commitments are made one way or another. The key factors for Sponsors to consider when deciding whether or not to use an IRT, while obvious in one sense, can get a bit muddy in others. Grids like the one below can help sort things out.

Why do I need an IRT?

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Long gone are the days when Interactive Response Systems (IRT/IWRS/IVRS) in clinical trials were thought to be just tools for simple 1:1 assignment of subjects to treatment groups, a no-brainer easily replaced by a few lines of code tagged onto an EDC platform. IRTs are now recognized as go-to systems of choice for controlled management of:

Risk-Based Monitoring with IRT

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The key to effective Risk-Based Monitoring (RBM) is data – having essential information in your hands in a timely fashion.

Interactive Response Technology (IRT/IVR/IWR), which long ago had its start as a ‘randomization platform’ for clinical trials, is now a powerful tool-of-choice for subject and drug supply management, yielding data that can and should be leveraged as RBM support for clinical studies.

Good RBM enables study CRAs/PMs to monitor, without leaving their desks, the status of key project variables – i.e., variables that indicate potential risks that might require an enhanced response, like scheduling a site visit, focusing additional site training, or feeding back to decision makers issues and potential issues in study conduct.

Getting to Market Faster…

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Getting to market faster is one of the major goals of every pharmaceutical company. Going paperless is one way CROs are reducing the time–and costs–required to complete and close a clinical trial.

According to CenterWatch (June 27, 2016), Sponsor use of electronic Trial Master File (eTMF) applications has doubled in the past two years. At the same time, use of paper for Trial Master Files has dropped to 28%.

As more CROs adapt to being paperless and bring their eTMF applications online, they need vendors who are able to keep up the same pace. Aware of the goal, Veracity Logic uses an electronic repository to store all of its project documentation. Once documents are fully executed (all relevant parties have signed off), they are moved to a shared electronic portal where the client is given access to download on demand any and all documents required for the Trial Master File.

“We understand the goals of the industry and are supporting those goals by having project documentation available to our clients long before database lock,” says Andrea DeStefano, Project Manager at Veracity Logic.

Do You Need a Secondary IRT Vendor?

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The Challenge:

The unpredictability of clinical trial scheduling and timelines is a ‘given’ in the world of pharmaceuticals. Seasoned professionals have learned the hard way that one’s chosen vendor in any given domain may not be sufficient to handle whatever comes along — in particular, the tendency of multiple studies, originally scheduled to begin at nicely manageable intervals, to suddenly bunch up in the same month or quarter. In addition, variations in study needs, size, and rules of conduct makes it hard to find a ‘one size fits all’ strategy. At the same time, establishing standard processes and patterns with a given vendor of choice has long been recognized as the most cost-effective and efficient approach to maintain consistency across trials. What to do?

The Solution:

Discussions at recent conferences of clinical trial professionals make clear that an increasing number of Sponsors and CROs of all sizes are overtly pursuing a dual-vendor strategy when it comes to key services like Interactive Response Technologies (IRT). Selection of a secondary (and in some cases, tertiary!) IRT vendor is increasingly an additional step in formal search strategies. Two different approaches were revealed. In one approach, secondary vendors were simply held to the same success criteria as were the winners of the primary search. In another approach, a subset of criteria were held in common between primary and secondary vendors, but with other, different criteria considered for the secondary vendor. For example, while a minimum company size might be a vital criterion for the primary vendor, the benefits of a smaller team — with increased flexibility and speed of response — might move to the top of the list for a secondary partner. Likewise, differences in customization costs and configuration practices might be paramount if smaller studies and/or ‘pinch hitting’ is to be a secondary vendor’s primary role. A smaller vendor who emphasizes ease of configuration may, for example, eclipse a second larger vendor who relies more heavily on up-front, franchise customization. In any case, the key to choosing a secondary vendor is to take the time to develop a clear understanding of what constitutes a winning set of secondary capabilities for your company’s given needs.

Third-Party Integrations…Reviewing What Matters

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With the cost of executing clinical trials continuing to spiral upward, Sponsor and CROs are increasingly relying on the ability to integrate multiple service providers on a single study. Integration…true integration, that is…must accomplish three key procedural (and thereby cost) savings regardless of the types of applications/tools being integrated:

First, the integration must eliminate costly and inefficient redundancies, and the reconciliation activities they inevitably engender. Second, data sharing between systems must occur in close to real-time in order to avoid misinformation and the wasteful time/cost consequences misinformation can generate. Third, integration must be able to be accomplished easily and flexibly, without causing long delays in startup timelines and, hence, negatively impacting project budgets. Fourth, the integration must be reliable–that is, users must be able to feel confident that data is accurately and consistently being conveyed.

Veracity Logic’s approach to integrations between its IRT system and leading EDC platforms in the field today meet all four of these critical criteria. Data initiated by the IRT — for example, screening IDs or patient randomization data — are shuttled on a real-time, transactional basis to the EDC system. There is no need to enter the same data twice, thus eliminating the need for reconciliation. Error monitoring and correction processes are built into the our approach to integration, enabling users to feel confident in the status of the integrated database. For example, should a transmission fail– either on the IRT or the EDC side of things — an email is automatically sent to IRT staff who can then take the necessary steps to address the issue and retransmit the file.

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Enhancing the IRT User Experience…

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The Challenge:

During the course of a clinical trial, users are required to learn and use a variety of systems. To ease the burden, IRT vendors need to provide an attractive, easy-to-learn, easy-to-use IRT interface that provides users with much-desired ‘data at a glance’ capabilities and allows them to execute critical tasks quickly, with a few simple clicks.

The Solution:

To meet this challenge, Veracity Logic has developed a table-based, data-centric approach that greatly simplifies the user experience by incorporating basic data processing/error reduction strategies like data toggles, row-level audit trails, tabular formats, check boxes, filters, and context-sensitive menus, while eliminating the kinds of graphic overloads that slow down other systems and result in user frustration.

Context-Sensitive Menus

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Veracity Logic’s VLIRT® web interface provides users with easy access to view data and a context-sensitive task menu for each record in the report. The task menu presents the users with only those options allowable for the selected record. For example, the task menu for a shipment that has been sent from the regional depot will allow a user to receive the shipment but will not allow the shipment to be sent again.

We’ve Got You Covered: Languages

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Interactive Response Technology solutions must be able to provide notifications in multiple languages as needed based on the countries in which a study is conducted. For IVR (phone) systems, voice prompts must also be translated and recorded in the needed languages.

We’ve got you covered! Veracity Logic supports over 40 languages including: