Interactive Response Technology (IRT) systems enable sponsors and study teams to manage complex clinical trials effectively. This makes them a beneficial tool throughout oncology studies, well-known for being the most difficult trials to run. By streamlining subject randomization, cohort and dose assignment, and patient interactions, IRT simplifies trial management to give teams more opportunity to focus on the patient.
While all phases of an oncology trial benefit from these features, the smaller patient populations and lower technology budgets of early phase studies have often restricted their use of IRT in the past. The industry is evolving, however, and the need for IRT in Phase I is growing.
“Early phase oncology trials have become more complex and difficult to manage manually via spreadsheets and other tools. Meanwhile, the functionality offered by IRT has developed to enable many of these complexities while allowing for the flexibility required by frequently changing protocols,” explains Maggie Fox, Design Consultant at Suvoda, provider of the industry’s leading IRT SaaS solution.
The need for flexibility
The dose a subject receives at a visit can be dependent on multiple variables, including the subject’s randomization assignment, the visit they’re registering, their weight, and the study cohort, part, age group, stratum or tumour type they’re assigned to. Using factors such as these, IRT helps study teams configure dose and dispensation. If anything changes, Suvoda IRT’s dynamic Dose and Dispensation Management module enables study teams to modify these configurations throughout the study.
“The possibilities to be dynamic are just about endless. Being able to offer that kind of flexibility to our clients makes them feel confident in having an IRT system for an early phase trial, where so much can change,” says Carley Wooden, Design Consultant and Group Lead at Suvoda.
It is also common for Phase I oncology trials to have cyclic visit schedules without a defined number of visits. To accommodate this, IRT helps sites and study teams define the rules for a cycle of visits, such as how many visits are registered per cycle, the visit windows within a cycle, and restrictions on how many cycles can be registered. By also offering the option for automated visit schedule expansion, Suvoda IRT allows the study team to continue registering visits as necessary, even if the study duration is extended beyond the initial forecast.
No room for error
There are so many reasons to use IRT in an early phase study, especially if the trial includes an adaptive design that allows the sponsor to modify the protocol based on changes influenced by data gathered as the trial progresses. “A flexible and robust IRT system is particularly useful in these cases because the system can be designed to both enable and enforce any protocol modifications that may occur related to randomization and dosing,” says Fox.
The biggest IRT advantage, according to Wooden, is the burden the system takes off the study team and sites. “Having a flexible, validated system means the study team doesn’t have to worry about so many factors that have been automated, like the site miscalculating critical calculations, misrandomizing subjects, dispensing the wrong drug units, or forgetting to resupply the sites. If used correctly, the IRT system should take care of those issues and greatly reduce risks, as well as introduce helpful features for an enhanced trial experience,” she explains.
By automating drug supplies, for example, IRT reduces the risk of sites not having enough inventory to treat patients, particularly in light of dose changes. This improves the patient’s experience, increasing the likelihood they’ll want to participate in additional studies with that sponsor. And leveraging these benefits early on helps build the right kind of trial momentum across the rest of the drug program, setting teams up for further success and ensuring smooth IRT usage in later phases.
The new generation of IRT
The need for a modern, flexible IRT system to manage early phase oncology trials is rising. The new generation of IRT, developed by Suvoda, is designed to handle all the challenges of Phase I oncology trials while providing easy integration and quick deployment. An increasing number of studies are optimising their early phase operations and reducing the risk of human error with Suvoda IRT, which promises speed, agility, and insights.
“As a Suvoda employee, I have received feedback from many sponsors that they enjoy working with Suvoda because we are easy to communicate and collaborate with, our core system is dynamic and can be easily configured and customized to meet even the most complex needs, our robust validation of the system means issues are rarely discovered during UAT, and our system functionality is straightforward and easily understood by sites and study teams. I think all of these factors, and more, give Suvoda a positive, trustworthy reputation that makes clients feel confident working with us,” says Wooden.