Overcoming RTSM Challenges in Oncology Trials Part 2
In an earlier blog we addressed one of the supply challenges that oncology trial sponsors face, the local vs. central sourcing of standard-of-care medications. Here we address additional randomization and trial supply (RTSM) factors that sponsors should consider, and how flexible IRT systems like Calyx IRT can overcome the challenges to help drive oncology trial success.
Disease Progression
In oncology trials, patients continue to be treated until the disease progresses. This leads to unknowns in how many visits a patient will have, which can cause issues during the setup of some IRT systems. This is another reason why flexibility in your IRT system is key.
At Calyx, we assume that the drug may outperform its mid-trial expectations and delay disease progression beyond initial estimates. So, we build overage into the setup from the start, which caters to the need for additional visits and avoids reprogramming work to ensure patient dispensing visits are recorded accurately.
However, if the drug is doing really well and delaying disease progression even beyond our initial overage estimations, the system design could still run out of visits and require reprogramming. So, in the case of a never-ending visit schedule, we build an alert to trigger when extra visits need to be added, well in advance of when the system requires them.
“Having flexibility built-in to your IRT system is key to tackling the drug supply challenges and unknowns that are inherent in oncology trials.”
— Malcolm Morrissey, Head of Statistics & Product Support Services, Calyx
This is one of the situations where the solution to one problem could cause another problem. In this case, the addition of extra visits and the need for drug overage can result in the sponsor facing drug expiration dates that will require additional packaging runs, which need to be planned for during the trial.
At Calyx, inventory management settings allow for flexibility to manage supply issues, such as considering whether a current batch can be shipped for longer time periods until the new batch is released. In addition to these live study IRT setting adjustments, identifying that the initial estimates were an underestimate is a key milestone check for the trial.
To avoid stock out, it would be important to include in the ‘last’ batch at the milestone check enough expiry to manufacture a follow-up batch at the point the underestimate is identified.
Visit Naming
Another unique RTSM challenge in oncology trials is the different naming conventions used to define patient visits. In IRT systems, typically a patient visit is typically called a ‘visit’, while in oncology trials, the protocol most often reflects where the patient is in their treatment ‘cycle,’ which is what investigative sites understand as the patient visit schedule.
It’s very important that it’s clear to the investigator what visit they’re registering, as well as what cycle and visit schedule the patient is in. So, it’s critical that the naming of the visit schedule in the system matches the protocol. With Calyx IRT, the system assumes the site registering the scheduled visit is doing so based on the patient’s visit schedule and what the previously registered visit involved. The site is asked to confirm the assumed visit schedule is accurate and, if not, is given the opportunity to change it.
This becomes even more important in instances when patient visit schedules are interrupted because rescue medication is required during or in between scheduled visits, meaning the patient may have to go off the study drug before they are able to return to their normal schedule. Or, in the incidence of an adverse event, which has further considerations for the IRT system in terms of safety pathways.
Decisions as to if/which treatment patients should receive in these scenarios are typically outlined in the protocol, which should always be followed through in the IRT system. Ensuring the IRT system dispenses the correct treatment at each visit and has the flexibility for the site personnel to confirm the visit and cycle number reduces errors, keeps the trial on track, and supports patient safety throughout lengthy oncology trials.
Click here for the final installment of the series, which focuses on the need for rescue medication and how it impacts study drug expiration dates and drug wastage in oncology trials.
