Oncology studies present some of the most complex trial supply challenges. The need for a robust IRT system with built-in flexibility is key to ensuring the right patient gets the right drug at the right time, every time.
Tackling the Unique RTSM Challenges of Oncology Trials
Effective RTSM in Oncology Trials:
Managing Sourcing Changes with Advanced IRT
In this webinar, Calyx’s Peter Tarbox shares the RTSM factors oncology trial sponsors should consider in their IRT design, focusing on how advanced IRT systems can accommodate changes in centrally and locally sourced medication for optimal clinical trial supply management.
Oncology trial sponsors face the following challenges:
Standard-of-Care Sourcing:
Trial sponsors can expect that locally sourced medication won’t be included in their IRT system’s medication checks conducted at the beginning of each visit. Incomplete medication checks can be detrimental to the course of the trial as they could result in a failed patient visit, a skipped randomization record, and/or forcing to the treatment that is assumed to always be available.
Impact of Rescue Medication on Drug Expiration:
When patients pause treatment to begin rescue medication, there is a risk of study drug expiring before treatment can resume. Your IRT system should be designed to reduce the risk of excessive drug wastage in these costly studies, while ensuring study drug availability when the patient can continue treatment, regardless of which visit/treatment schedule the patient returns to.
Unknown Patient Visits:
Because patients continue until disease progression, the number of visits each patient will have is unknown. If your IRT system isn’t designed with this in mind, you could face mid-trial reprogramming work to ensure patient dispensing visits are recorded accurately.
The solution design and technical experts behind Calyx IRT have published a variety of resources to help sponsors better understand the RTSM risks that often occur during oncology clinical trials and how to mitigate them to drive successful oncology clinical development programs.
