Interactive Web Response Systems (IWRS) and Interactive Voice Response Systems (IVRS) are the technologies that research sites use to enroll patients into clinical trials, randomize patients, and manage study drug supplies. The two technologies fall under the umbrella term Interactive Response Technology (IRT). While the technology may sound straightforward, it's a critical piece of every clinical trial. When looking for a new system, it's important to find one that has the functionality you need to save time, keep your data organized, and save on drug supply costs.
While the vast majority of sites today use a web-based system, it can be helpful to understand the background of the technology.
IVRS (Interactive Voice Response Systems): This technology first appeared in the 1970s, and was the first way site administrators were able to enter patient information remotely. Users entered information in response to voice prompts through the keypads on a phone — something that couldn't be done on a rotary phone. In the 1980s, IVR systems became more affordable and widespread across sites.
IWRS (Interactive Web Response Systems): The later, internet-enabled version of IVR first appeared in the 1990s. It worked the same way, only a user would respond to prompts on a computer rather than over the phone. Modern systems can also easily integrate with other technologies, so you can connect your IWRS with lab eligibility, for example.
If you're feeling a little overwhelmed by all of these acronyms, we have some bad news. In addition to IRT, there's another acronym for this technology that's become more widely used: Randomization and Trial Supply Management (RTSM). This latest term refers to the role the technology plays in a trial.
Your IRT system can be used for a range of features during your trial, including:
Patient management: Through web or voice prompts, a user registers patients and records information about their site visit. Patients are also randomized through an IRT and assigned a treatment arm, all while keeping patient identities blinded. Your IRT will be programmed with your trial's unique randomization algorithm.
Supply chain management: Your IWRS is also used to control the inventory of your study drug and dispense to patients. Modern systems are able to manage complex dispensing protocols and calculate dose. Some technologies can also use an algorithm to predict when you'll be running low on a study drug based on patient enrollment and drop-out rates. Others allow you to track the shipment when it's in transit, and monitor for temperature changes that may damage the shipment.
Documentation and reporting: Study managers have access to automated system reports for real-time information about the trial.
Integration with other systems: When choosing a vendor, ask whether their IWRS will integrate with your site's existing systems, such as your clinical trial management system, Electronic Data Capture (EDC) system for capturing clinical trial data, etc.
In the past, it typically took several months for an IVRS to be configured. Clients would typically write 200 to 300 page system specifications, which needed to be coded and then tested, according to a history of RTSM in Applied Clinical Trials.
With IWRS came configurable systems. Many trials could now be set up out of the box by selecting information about a trial's treatment arms, dosing, visit schedule, etc. Configurable systems allow you to set up your IRT for a new trial easily by adjusting those factors for each trial.
Today, IRT systems can be configured for ever more complex trials with multiple treatment arms, or titration trials. IWRS can also be used for adaptive trials, which change as data comes in.
When you start talking with IRT companies, share an example of your study protocol so the team can get a sense of how easy it would be to set up, and how much additional support you would need.
Integration is one of the most important features to look for when shopping for an IRT today. In the past, IRT systems and electronic data capture (EDC) systems were separate. An EDC system is what statisticians use at the end of a trial to analyze data, and prior to integration between an IRT and EDC, data from the IRT had to manually uploaded to the EDC.
Today's systems communicate with EDC systems so there's not a need for duplicate data entry or data reconciliation.
IRT systems can also connect with electronic patient-reported outcome (ePRO) technology. Patient data can be collected over the phone or through a website or app, depending on the offerings of your particular vendor. When you're first talking with potential vendors, ask what technologies easily integrate with their product. If they offer other technologies you're in the market for, such as electronic data capture (EDC) or electronic patient-reported outcomes (ePRO), getting them from the same vendor ensures simple communication between them, too.
Veracity Logic is an IRT provider based in North Carolina. They've been in business for about 12 years and have done around 150 projects with users in nearly 50 countries. We spoke with David Goldston, managing director of Veracity Logic, about how to find the right IWRS system for your clinical trial.
In addition to the advice included in the below video, 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.
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.
Running a clinical trial is complex, from enrollment to randomization and data analysis. Antidote can help make the patient enrollment piece of your project easy by connecting you with engaged patients quickly and efficiently. Learn about the unique way Antidote connects patients with research by downloading our case studies below.