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The added complexity of oncology trials The need for effective cancer treatments remains a top priority in drug development. However, oncology studies are highly complex and trial sponsors are encountering a range of unique challenges that may be further complicating the evaluation of potentially life-saving therapies. A recent Tufts CSDD study revealed that the


duration of clinical trials for oncology drugs is between 30% and 40% longer than other drug trials, due to more complex designs and enrolment difficulties. Analysis also showed that Phase II/III oncology trials have more protocol deviations and generate more substantial protocol amendments than trials for other drugs. Many of the complexities and challenges associated with oncology trials can be addressed through a focused Interactive Response Technology (IRT) approach. An IRT system ensures day-to-day trial activities run smoothly for the sites and study teams. The software is used to prevent human errors in a wide range of critical study areas, including subject stratification, randomisation ratios and treatment assignment, dose modifications and calculations, drug resupply and shipments, drug dispensation and expiry, and overall study blinding, to name a few.


IRT for oncology trials


All studies can benefit from a well-designed IRT system, but for oncology teams, choosing the right platform for demanding, and sometimes shifting, study needs is essential – especially early on. “A focused IRT approach is required to ensure that the system design accounts for all scenarios that could arise over the course of the trial,” says Maggie Fox. “My recommendations for oncology study sponsors and their protocols are typically geared toward creating the most flexible design possible that still limits human error in critical areas.” Suvoda is a leading IRT software provider that specialises in oncology trials. The company’s advanced IRT with Trial Intelligence solution has already been an instrumental tool in 260 oncology studies, providing clinical teams with the dynamic control they need over several important study functions. “Oncology trials often require our dynamic cohort and dose management modules, as well


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as our dose modification and interruption modules, and these typically all interact,” adds Fox. “Enrolment criteria for an oncology study may also be relatively restrictive. We can account for this in the IRT design by ensuring the enrolment process is flexible to prevent subjects from being lost due to IRT issues.” 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 Fox.


The need for flexibility The dose a subject receives during a visit can be dependent on multiple variables, including the subject’s randomisation 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. It is also common for Phase I oncology trials to


“Many of the complexities and challenges associated with oncology trials can be addressed through a focused IRT approach. The software is used to prevent human errors in a wide range of critical study areas, including drug dispensation and expiry”


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