What are IWRS and IRT in clinical research?

Interactive Web Response Systems (IWRS) and Interactive Voice Response Systems (IVRS) are technologies used by research sites to manage patient enrollment, patient randomization, and study drug supplies. Collectively, these technologies can be referred to as Interactive Response Technologies (IRTs) or?Randomization and Trial Supply Management (RTSM) . These systems are a critical piece of every clinical trial, so when looking for a new one, it's important to choose one with the right functionality.

An overview of IWRS and IVRS

IVRS (Interactive Voice Response Systems): Introduced in the 1970s, IVRS technology provided site administrators with the ability to enter patient information remotely for the first time. In response to voice prompts, users could enter information on their keypads to provide input to the system.

IWRS (Interactive Web Response Systems): With the introduction of the internet in the 1990s, it was not long before IWRS technology was introduced. It was a similar system, though a user would respond to prompts on a computer instead of doing it over the phone. In the modern day, these systems can also talk to other ones — for example, IWRS systems can communicate with lab eligibility systems in order to streamline processes.

What are the features of an IRT?

The IRT, meaning whichever IVRS or IWRS system is being used, can benefit a trial in a number of ways, such as:

Patient management:?Through web or voice prompts, site staff can register patients and record information about their visit. An IRT can also be programmed with a trial’s unique randomization algorithm, so patients can be blindly randomized and assigned to a treatment arm.

Supply chain management:?An IRT can also be used to track the inventory of a study drug and dispense it to patients, even with complex dispensing protocols and dosage instructions. More advanced IRTs can also use an algorithm to predict when a study drug supply will run low based on patient enrollment and drop out rates, track drug shipments, and monitor for temperature changes that may cause damage.

Documentation, reporting, and integration:?Study managers can access automated system reports to receive real-time information about the trial. Many vendor’s IRTs will also integrate directly with a site’s existing systems, such as the clinical trial management system, Electronic Data Capture (EDC) system for capturing clinical trial data, and more.

How will my IWRS be configured?

Before technology advanced to IWRS, it would typically take?several months for an IVRS to be configured . It was once required that clients write a 200- to 300-page system specifications document, which would then need to be coded and tested to get the IVRS up and running.

One of the biggest benefits of early IWRS technology was configurable systems. By selecting information about a trial’s treatment arms, dosing, visit schedule, and more, trial systems could easily be configured in very little time.?Today’s IRT systems can be configured for even more complex studies ?that feature multiple treatment arms, titration trials, or adaptive trials that change as data comes in.

When discussing your trail with IRT companies, it’s helpful to share an example of your study protocol. This will allow the team to get an accurate sense of how easy it would be to set up and how much additional support may be needed

How can I make sure my IRT communicates with other systems?

When choosing an IRT, integration is one of the most important features to consider. In the past, IRT systems and electronic data capture (EDC) systems were separate, which required data from the IRT to be manually uploaded to the EDC. Fortunately, today’s IRT systems feature more integrations, so there’s usually no need to perform complicated data reconciliation procedures.

Additionally, many modern IRT systems can also communicate with electronic patient-reported outcome (ePRO ) technology, allowing sites to collect patient data directly through a website or app. When talking with potential vendors, ask what technologies easily integrate with their products to be sure everything will work together seamlessly.

What to look for in an IWRS: A conversation with Veracity Logic

Veracity Logic ?is an IRT provider based in North Carolina, and we spoke with David Goldston, Managing Director, about how to find the right IWRS system for your clinical trial. In addition to the advice included below, the company also created a handy?checklist for evaluating IRT vendors .

Q: How have IWRS features changed in the last few years?

IVRS started being used in the 1990s. Most of my experience with that technology was for subject diaries. The subject called in and used the system to answer a series of questions. The system would record those entries into a database. As we moved into the web, people were able to do start doing more with the system, they would screen the subject, record subject activities, randomize the patient — that sort of thing — as well as controlling shipments to and from the central warehouse. Being able to request, send, and receive those shipments in the system once the shipment was received, the kits were made available at the site for assignment to subjects, so you ended up with a lot more control of the drug assignments and keeping track of everything.

As technology has advanced and acceptance of these systems have become more prevalent, we've expanded the functions that can be performed. Now not only do we do shipment handling, but we can track temperature deviations within the system, so instead of having to say this shipment was damaged, you can now say that the shipment experienced a temperature deviation and later go in and determine that they were not outside the temperature range for too long, so you are able to still use it after all. That results in less wastage.

Also, you can do more and better randomization options. For instance, For very small studies we can make it dynamic, rather than having them make a table of the order in which randomizations will occur, the system will use an algorithm to determine how to keep the study in balance between active and placebo medications. Also if you're doing a dosing study where you have four dose levels, you're trying to determine the minimum effective dose for a drug, you can use an IRT to say we're seeing more SAEs [serious adverse events] at this highest dose level, so we're going to turn that one off, so just the lower dose levels are used. All of these are flexible. It doesn't matter how many dosing levels you have, you're able to control dosing at the kit level. So you can say for example, we had a study that had 28 different kit types of various dose levels in each kit. Sometimes subjects would get one kit, sometimes they would get two or three kits depending on the dose level they were assigned. You can get very complex studies that can be handled by the IRT, making it easier for site users and the project team to manage the study.

Q: What advice do you have for making sure your IRT can communicate with your other technologies?

That is another one of the improvements that's been made over the years. As IRT systems are used for more and more studies, you also have an EDC [electronic data capture] system, typically it's the clinical database that's used by the biostatisticians at the end of the study to do their analysis. We have much more and much better interactions between the IRT systems and the EDC. For instance early on, IRT data would be transferred let's say nightly, or on a schedule to the EDC, and then the EDC team would have to import that data.

Nowadays, with the improvements in the web and the technology supporting web systems, we can use something called web services to actually have our system connect to the EDC and it opens what they call a port, and the data is pushed into the EDC as if someone had sat there and entered that data. So the advantage of this is that users can come into the IRT, record a screening for a subject, the date of birth, maybe their initials, key information required at screening, then the IRT system can assign the number and push that information to the EDC. Then when the user logs out of the EDC system and back into the IRT, they can see the data already present, already populated for that particular visit and they don't have to re-enter that particular information.

One of the best practices is to set it up so that in the EDC system, data that's transferred from the IRT is not editable, so a person can't go through the EDC system and make an edit to that data. By having them come into the IRT, And then re-pushing that data to the EDC, it eliminates the duplication of effort for the user to have to enter the information into the EDC and the IRT system, and it also eliminates the need for reconciliation between the two systems at the end of the study. So that reduces the cost and the time for the sites.

What to Look for in an IWRS: A conversation with YPrime

As you shop around for your next IRT system, there are several different factors and functionalities to keep in mind to find the system that’s right for you. We talked with Justin Jaeschke, Senior Director of Client Engagement at IRT company?YPrime ?about their advice for choosing the best system for your needs.

Q: What is IMRS (Interactive Mobile Response System)?

That's more based out of a mobile device. The response experience will be delivered through a mobile application. Typically, that mobile app really allows the end user to access real-time information, reporting and even run the actual clinical functions through a mobile handheld device. It could be a tablet, it could be a smartphone.

Q: Can you speak to what features someone should be looking at when they're choosing an IRT system?

For most of our customers, quality and timelines are extremely important to them. That's really important when you're selecting an IRT. A lot of our customers are looking for configurability, meaning that essentially the configurability allows them to hit more aggressive timelines and make sure that quality objectives are met. A lot of that configurability allows you to react to the common things that change from protocol to protocol, like visit schedule and the questions that are asked during screening or randomization. Ensuring that you have a configurable system is a very important part of making your decision on which IRT to choose.

The other thing I see is around the experience that the team has that you'll be working with. I think the experience of using IRTs and best practices and being able to apply that to that sponsor's protocol design is important as well.

Q: Are there any newer or interesting features that have shown up in the last few years?

There really have been. There are a number of things that IRT can do now that traditionally you just wouldn't have expected. I think of things like direct-to-patient shipment that's part of some protocols now. You're treating patients who are in a state where they can't attend a doctor's visit in person. There are IRTs now that can work for that trial design. [Another example is] adaptive trials, where decisions are made about the trial design as data is received. Those are really important new features as part of the IRT that we're seeing. Another thing that I think there's a lot of emphasis on now is a lot more advanced clinical supply features with an IRT, so being able to modify your resupply strategies in real time, interacting with the parameters that deal with the predictive nature of your resupply. IRT in general I think now more than ever is such an important part of the clinical trial ecosystem. We're seeing a lot more need for data integration and sharing of data between IRT and many systems.

Q: Going back to the question of integration, do you have any advice for sites that are looking for a new system to make sure it can communicate with their other technologies?

Historically, I think IRTs, especially over the last 10 years, it's become pretty common for them to integrate with their electronic data capture system. That should be considered standard if you're looking for an IRT system. I think it really expands beyond that today. It's important for IRTs to be able to communicate with lab systems, with different distribution centers to make sure your drug orders are electronically sent. At YPrime, we have architected a system that doesn't just integrate — we share a common technology with our ECOA platform, our ePRO devices. So our IRT and ECOA share a common architecture. That allows us to share information about our patient data, such as dosing data in real-time. It's really important to have those communications, those integration points to data reconciliation issues and avoid duplicate data entry and things that can really cause a lot of reconciliation work and a lot of manual data processing checking time.

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