Oncology Trials, with frequent dosing modifications, variable cycle quantities, and other unpredictable factors, can pose unique challenges to the work of Clinical Trial Managers (CTM) and Clinical Supply Managers (CSM). A flexible Interactive Response Technology/Interactive Web Response System (IRT/IWRS) can assist in the management of these complex trials. This post will highlight some of the challenges and design elements that must be considered when implementing an IRT/IWRS that can address these nuances.
Managing Drug Supply with an Undefined End of Study Treatment
Unlike many clinical trials that have a fixed duration, oncology trials are often designed to adjust trial duration based on the individual subject’s response as well as the overall results across the trial. When selecting an IRT/IWRS provider, look for a flexible IRT/IWRS system that can dynamically expand visits for subjects that are eligible for continued treatment.
By dynamically expanding the visit schedule for only those subjects that are reaching the end of their current visit schedule, study-wide drug projections are not altered when a single subject reaches the expansion point. This ensures that drug configurations can remain consistent throughout a trial, requiring less intervention whenever a subject’s schedule expands.
Unknown Start and End Dates of Cycles
In situations where treatment cycles may begin earlier or later than expected, an IRT/IWRS with a rigid and/or static visit schedule cannot easily accommodate shifting visit dates.
Implementing a system capable of re-projecting a subject’s entire visit schedule after the beginning of each cycle, or even after each visit, can address this scheduling challenge. Because subjects may not always come in for their scheduled visit on the expected day for various reasons, such as adverse events or personal conflicts, ensure your IRT/IWRS can project future visits based on past ones.
Unscheduled Visits and Dose Withholding
Scheduled visits are included in visit schedules so the IRT/IWRS has a general timeline as to when subjects will receive study treatment. In the event a subject is not ready to receive their next dose, unscheduled visit and dose withholding capabilities allow you to manage these exceptions in a safe and controlled manner.
Dose withholding is designed to handle subject safety during the administration of experimental study drugs. This is critical in oncology clinical trials since subjects are in situations that could make them sensitive to certain treatments.
When implementing dose withholding functionality, it is also critical to make drug available again for subjects who have had drug withheld. Unscheduled visits allow the flexibility for subjects to remain on a course of treatment even if an experimental drug could not be administered at the previous scheduled visit. Therefore, any previously withheld drug within a cycle may be dispensed at a time that is more tolerable for the patient.
Dose Modifications in Cycled Visit Schedules
There is a delicate balance between modifying a patient’s dose to suit their personal needs and managing the clinical trial successfully per the protocol. An IRT/IWRS equipped with the ability to adjust doses based on subject safety and tolerance per the protocol ensures adherence to the maximum and minimum dose levels.
Finally, tracking subject dosing may be problematic in oncology clinical trials that consist of various dosing options. Your IRT/IWRS should contain robust subject visit reports, along with ad-hoc reporting capabilities, that specify the previous and current doses for each subject.
Conclusion: Addressing these Challenges
Selecting an IRT/IWRS that is robust enough to handle the unique challenges of oncology trials can help CTMs and CSMs reliably manage the unexpected. Your IRT/IWRS should be able to manage drug supplies with an undefined end of study treatment, unknown start and end dates of visit cycles, unscheduled visits and dose withholding, as well as dose modifications in cycled visit schedules.
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