Oncology trials in all their complexity can pose unique challenges. A dynamic interactive response technology (IRT) system is crucial to respond quickly to aspects like frequent dosing modifications, variable cycle quantities, cohort and expiry management, and other unpredictable factors.
IRT can improve speed and flexibility to make the jobs of clinical trial managers (CTM), clinical supply managers (CSM), and site teams much easier. This post will highlight some of the challenges and system elements that must be considered when designing and implementing an IRT that can manage change more dynamically and efficiently.
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 provider, look for a flexible 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.
Dynamic expiry management
Since many oncology studies will allow for additional cycles of treatment as long as the patients are deriving benefit, drug expiry has to be more closely monitored. For instance, a number of oncology study designs have larger gaps in time between visits later in the subjects’ enrollment in the study. These gaps in time are typically 4, 6, or 8-week intervals. For these later visits, the system needs to dispense more drug with a longer expiry range so that the drug doesn’t expire in the patients’ hands.
IRT systems can allow for more dynamic expiry calculation based on each drug product and visit intervals. This enables studies with changing visit intervals to optimize their drug supply to reduce waste and costs.
Unknown start and end dates of cycles
Treatment cycles may begin earlier or later than expected. 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 can project future visits based on past ones.
Unscheduled visits and dose withholding
IRT systems have a schedule to define when visits happen for patients so that it has a general idea when subjects will receive study treatment. In the event a subject is not able to make it to a clinical site visit or 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 and potentially experience adverse reactions.
When implementing dose withholding functionality, it is also critical to have the capability 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 or convenient 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 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. Robust subject visit reports, along with ad-hoc reporting capabilities that specify the previous and current doses for each subject can be vital to tracking these shifts.
More and more, oncology studies are organizing patients into cohorts to measure how patients with particular characteristics (e.g. genetic mutations) will respond to the investigational product being tested. They may even group these cohorts together by things like dosage, disease type, or another data point that allows them to explore how the different groups of subjects do.
IRT can be configured to manage cohorts dynamically. For instance, systems now have the flexibility to add cohorts in real-time as needed and to eliminate cohorts where appropriate.
Conclusion: Addressing these oncology study challenges
Selecting an IRT that is robust enough to handle the unique challenges of oncology trials can help CTMs and CSMs reliably manage various unknowns. When built for complexity, IRT can manage drug supplies with an undefined end of study treatment, unknown start and end dates of visit cycles, unscheduled visits and dose withholding. It can also handle dose modifications in cycled visit schedules, and allow dispensation of drug that will not expire during treatment cycle extensions. Lastly, it can add and subtract cohorts as needed.
This kind of flexibility helps study teams adapt quickly to changes, and gives site teams the efficiency they need in their workflows so that they are better able to focus on patients.