The IRT clinical trials use has changed dramatically over the last few decades. The increase in complexity of the trials has led to a drive for more IRT capacity, and the improvements in software design have in turn allowed for major leaps in trial complexity without the danger of weakened security.
So, there’s a complementary arms race going on between the trials and the software that facilitate them, and IRT is one of the frontiers of modern trial software. But what is IRT in clinical trials, and how does it relate to their growing scale and complexity?
We’ve got all of that covered in this article, so prepare yourself for a bombardment of initialisms.
What is IRT in Clinical Trials?
Before smart devices, clinicians were making use of IVRS, or Interactive Voice Response Systems. These involved calling in from a landline and screening patients by entering details into the system via the keypad, which would then assign each patient a number and confirm by email or fax that the subject had been randomized.
This system was of course clunky and prone to human error, so the advent of the internet provided great improvements on the old system.
From the IVRS, an Interactive Web Response System (IWRS) took over. This is a very similar system, for screening, randomizing patients, and dispensing medication, except it uses a web interface instead of a call, making it much easier for users to see what they were entering.
Still, the IWRS handled only a select few roles in clinical planning and execution, and multiple other software were required to work independently of one another, alongside IRT, to cover other elements of the trial.
Both the IVRS and the IWRS could be considered a form of Interactive Response Technology, or IRT. However, are many advancements that modern IRT offer that aren’t present in their predecessors.
New web-based systems allow users to enter information based on clicking on visible options; much more straightforward and accurate than using keypads. This immediately improves data integrity on both sides of the operation.
But where modern IRT systems really shine is in their ability to integrate with other systems and reduce the need for double-entering of data. Not only does this save time, but it reduces the chance of human error.
Modern IRT are typically more advanced and can often integrate with electronic data capture systems (EDC) and electronic patient recorded outcomes (EPROs). As they advance, they’re also being used in more planning stages, to cover inventory, resupply, and distribution of resources.
To put it simply, IRT is a general term for all of the above systems by which coordinators can screen patients, randomize them, and modern versions can be integrated with different systems to process a handful of other relevant data, such as recruitment or EPROs.
But with more modern IRT, the applications go a lot deeper. The importance of such a system comes from the increasing demands and complexity of modern trials, and IRT is doing a good job of keeping up with these demands.
One of the most critical aspects of a fair and unbiased trial is randomization. Before we look into the other benefits of IRT, it’s important to understand why randomization is so important.
The Significance of Randomization in IRT Clinical Trials
There are several useful features to modern IRT, but the primary significant one is in the randomization in clinical trials. But what is it, and why is it important?
Randomization in clinical trials works by assigning each individual a group based on a random number generator. Each group will receive different treatments in the study.
For example, patients are assigned to two groups: one is the investigational group, and the other is the control. These two groups will be compared throughout the study, and by randomizing the assignments, there is no chance of human bias from the investigators at play.
The benefits of randomization as part of the scientific process are relatively well understood. There are also four main stakeholders in clinical trials who benefit differently from controlled randomization:
- Randomization of patient data first of all benefits patients. With controlled randomization, patients can receive an exact probability when starting the trial that they will be given a potential treatment for their disease, as opposed to a placebo.
- It also benefits sponsors: sponsors get the reassurance that these treatments will be administered as part of a fair and unbiased clinical setting.
- Data analysts benefit from randomization too. By remaining blinded to the data associations, they can conduct unbiased analyses.
- Finally, Regulatory bodies are also on the list of beneficiaries for randomization. This again relates to the unbiased processes of dealing with randomized data to guarantee scientific rigor in the clinical process.
Ultimately, randomization removes confounding variables, improves the power of statistical analyses, and helps to balance subject attributes across groups.
While it’s not typically difficult to randomize small amounts of data, the complexity of clinical trials is increasing steadily, and with it, the amount of data that needs to be managed.
This is where the IRT clinical trials use presents some of its major benefits.
The Modern Roles of IRT in Trials
Randomization in clinical trials is lauded as the best standard of research in clinical trials. Using IRT to handle the randomization process helps trials manage huge amounts of data with the least amount of bias.
The advancements in such systems allow them to handle increasingly complex data sets and accommodate equally complex allocation methods that reduce other imbalances while simultaneously taking into account numerous variables such as the stage of the disease and other prognostics.
This capacity for managing data can take the strain off the alarming cost of around 30% of financial resources that are currently being used up in the data management arm of clinical trials. It can do this without reducing any standard of integrity or risk mitigation.
This allows for complexity to continue to increase, with more treatment arms, more titration trials, and larger sample sizes both in terms of longevity and patient cohorts; all manageable with advanced IRT systems.
It also means adaptive trials can be handled with more efficiency, and shifting approaches as these trials progress are more than manageable. Data in trials where the quality of the data being processed changes as the trial progresses have, in the past, been very fiddly and cumbersome to manage. Modern IRT is designed with this in mind and can save tremendous amounts of time, double-data and human error in these contexts.
Each trial can have its randomization algorithm assigned by the IRT, and from there, web or voice prompts can register patients and record their detailed information regarding any site visit. Then, the IRT can assign them a randomized identity and a treatment arm, keeping all human components blind. This helps significantly with patient management.
System reports can be automated and real-time information about the trial can be readily available to organizers and managers. This allows for remote access to information, as well as access to critical points of touch that are accessible remotely to anyone who needs them.
But the role of the IRT clinical trials use has moved away from simply interactive response technology and into the realms of the automation of numerous logistical mechanisms relating to the trial itself.
Modern IRT can also help deal with your supply chain, by managing dispensary protocols and dose calculations. It can predict your inventory based on enrolment data and drop-out, and some can even track shipments from vendors.
As of now, its utilization as a valuable resource in logistics and distribution is lacking. Among a multitude of applications, IRT can help with logistics by managing shipping sizes, returns, storage limitations, and top. It can even handle blinding during shipping, which involves shipping groups where a study needs groups to be shipped together to maintain blinding.
As the software improves, it can sometimes take stakeholders some time to get onboard. With all these applications, investors may be hesitant to invest in a single product that holds so much responsibility for the process. However, there are significant perks to having one system in charge of so much.
Many of these perks come from customizability, and the capacity of IRT to integrate with other systems too.
The capturing of clinical trial data should be one of the first on the list of things to integrate with IRT. While IRT and EDC were traditionally separate processes, the new IRT systems can communicate with EDCs directly, with no need for duplicate data entry processes.
So, when looking for a system, Integration, therefore, is one of the most valuable aspects to look for in an IRT, but there are numerous others to take into account too.
What Kind of IRT Trials Should Look For
The most important factors in an IRT system for most people are timeliness and quality. In many cases, something that speeds up a process also reduces its accuracy; a sacrifice that cannot be accepted with the high expectations of data security and scientific rigor that come with clinical trials.
In many trials, both of speed and accuracy of processes can be impacted by the range to which the IRT product can be configured to suit their needs, meaning that an IRT with a high capacity for diverse configuration is of the greatest value to investigators.
The better the configuration, the faster processes can run, and the more versatile the IRT will be for future applications too. This allows people to hit stricter deadlines while maintaining the quality of their objectives, and achieve these across different trials.
With protocols that change, such as in adaptive trials, this is a critical function of a powerful IRT. Scheduling visits and questionnaires change with stages, therapies, and demographics, so being able to configure allows coordinators to keep up with this.
When looking into using an IRT, however, it might be worth prioritizing one that your team has experience with. Whether it’s optimal or not for any specific trial is in some cases less relevant than whether it can be operated effectively by the people available, so you may find that you’ll save time in adjustments and training if you stick with what you know.
Modern IRT can now predict and automate shipping, both to patients and to your stores and keep track of inventories. They’re also more predictive than before and can integrate with other systems.
Essentially IRT has the opportunity to sit as a hub of drug and inventory assignment and resupply, keeping track of vendor selection and updating continually. As such, it’s involved in a lot more of the planning process, and can be implemented sooner than more traditional methods.
Ultimately, a modern IRT bridges the gaps between supply, clinical sites, and the patients themselves, and saves costs tremendously as a result. With so many potential applications, the single most important factor to look for in IRT is configuration.
Further Points on IRT/EDC Integration
As IRT software improves, the capacity for integrations grows. As a result, IRT companies are now boasting some impressive integration potential, and this translates strongly to a much more streamlined clinical trial process.
Protocols are becoming more complex almost across the board, due to increases in regulatory data demands, commercial drivers, the complexity of the data itself, and the subsequent risk factors associated with this complexity. Here’s how some of these factors break down:
- Modern trials, such as with personalized medicines, simply require more data to be collected and processed at every stage and phase of the trial.
- For example, the number of data points collected in phase 3 studies alone has more than doubled in the past 15 years. This is a response to the power of the analysis required to satisfy stakeholders.
- The rise of genomics means that studies are rarely focused on a single molecule now, further complicating the process, and requiring a lot more data and samples to be taken.
- Regulatory and commercial entities are creating pressure to provide high-quality data early on; if they’re going to fail, they want to fail early. This drives the need for more and better data at the beginning of the trials to ease the nerves of stakeholders.
- As investigators take on a more patient-oriented approach, they are seeing higher levels of patient retention. While this is a huge saving in resources, it means that trials need to present more data to patients at the early stages of their involvement. Patients want to be more informed, which requires more engagement and, of course, more data.
But how does this relate to integration? Well, modern IRT and EDC systems are being designed specifically for these complex trials to reduce investigator burden and optimize workflows. Data split between different systems, such as between EDCs and IRTs, used to have to be entered twice, or manually integrated.
There are still many investigators who say that they’re struggling with this issue. When polled, most coordinators state that they are working with more than one IRT and EDC vendor. Of those, around half are considering switching to a single vendor for simplicity.
This is the market that modern IRT systems are not striving to fill. New systems are focusing strongly on the streamlined integration between the IRT and the EDC systems. Now, at the planning stage, key demographic like age, gender, etc., can be entered into the IRT and a patient ID can be created. As soon as this happens, a casebook ID can be immediately integrated into the EDC.
The immediate benefit to this system is in re-screening. If a patient is screened and fails, any subsequent re-screenings would typically need to be entered into the system again. With a casebook ID from an integrated IRT/EDC, this is no longer the case.
There are too many specific benefits of this integration to list here, but it should be clear that focusing on these integrations can solve many problems for complex trials. Ultimately, these improvements are centered around efficiency, simplicity, better data, and lower risk.
Conclusion
The systems of IRT trials now use have come a long way from the time of the interactive voice response systems of the past. They’re now close to a comprehensive data collection and storage service, running many processes at once and capable of processing vast quantities of patient, trial, and supply data.
One of the major benefits of the modern IRT is in its ability to deal with blinding and randomization at a pace that keeps up with the increasing demands of modern clinical trials.
There are numerous vendors for both IRT and electronic data capture systems, but if you’re curious about what to look for in an IRT system, customization and integration are two of the most critical components for handling diverse qualities of trials.
A well-integrated IRT will save time, and money and improve security while keeping up with the growing complexity of clinical trials.
