How to Successfully Plan and Track Patient Visits in Oncology Trials

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 Perceptive 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 Perceptive, 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.

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 Perceptive, 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 Perceptive 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.