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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’s 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 randomisation 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, misrandomising 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.
Preparing for unexpected changes Unexpected changes often arise in oncology trials, so IRT systems need to accommodate such events without the need for formal system updates. One example is mid-trial updates to dose
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“By automating drug supplies, IRT reduces the risk of sites not having enough inventory to treat patients, particularly in light of dose changes. This improves patient experience”
levels. “With oncology trials, we often see updates to dose levels in protocol amendments,” says Wooden. With some IRT designs, this could mean contacting the provider for a system update mid-trial, raising costs and impacting timelines. But with Suvoda’s dose management functionality, study teams can add additional doses independently, as and when needed. “If all of the doses for a study are not known during the initial build, or if the study team is not confident the list of available dose levels will remain the same throughout the study life, we can utilise a version of dynamic dose and dispensation management customised to meet their exact needs. We can make it possible for them to add additional doses through the user interface without having to contact our team for a system update later on in the trial,” Wooden explains. The modular infrastructure of Suvoda’s software enables customers to select the oncology-specific functionalities they know they’ll need. “Utilising a modular approach optimises customers’ costs and timelines because we are able to implement already developed and formally validated functionalities on new studies more quickly,” explains Wooden.
Oncology trial design is becoming increasingly
complex, with even early phase studies utilising a variety of cohorts and different dosing schedules and frequencies. Managing this with paper processes and spreadsheets is becoming less and less feasible and is resulting in errors that could have easily been caught with IRT. Across all three phases, sponsors are now looking to take advantage of the efficiencies that IRT can offer, all from one platform – especially when it’s most essential, in Phase I. To ensure study needs are met on time, Suvoda’s flexible IRT solution is the tool that study teams and trial sites need to work through all the unknowns and complexities of oncology trials.
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