Customizable IRT drives Personalized/Precision Medicine trials

Randomization & trial supply management (RTSM) are critical functions of Interactive Response Technology (IRT) systems which have supported clinical trials for decades. Applying standard IRT design to the specific and novel needs of personalized medicine trials has been challenging, especially in the following areas:

• Supply chain — accelerated manufacturing, manufacturing slot management, personalized shipments
• Expiry management — just-in-time (JiT) shipping, very short expiry, rapid time to treatment administration
• Operations — complex/innovative study designs, participant recruitment and scheduling, effective cross-team communication
• Participant management — reserved medication, visit scheduling, brief time window from consent to treatment

Regardless, the number of personalized/precision medicines trials is increasing, accounting for around 25% of new drug approvals for each of the past nine years, compared to less than 10% of new approvals a decade ago. In 2023 alone, 20 personalized medicines were approved by the FDA, representing approximately 38% of all newly approved therapeutic molecular entities.[i] The increasing interest in and complexity of personalized medicine trials necessitates IRT systems capable of helping to overcome their specific and novel challenges.

Perceptive‘s IRT is built on a foundation of pre-programmed and validated functionality, designed to enable faster set-up through configuration. It can also be tailored to solve specific study challenges, including those common to personalized medicine of participant-led manufacturing and shipping, with extremely tight time windows.

The ability to tailor the IRT to meet the needs of both a traditional/typical supply chain and a participant-led, personalized supply chain is key. Customizing the system allows for the tracking of personalized stock from the manufacturing request through to dosing confirmation, with the ability to add linking data: for instance, a chain of identity (COI) tracking number associated with both a personalized medication and its intended recipient. Actions for specific scenarios can also be a part of the IRT design. Whether a Sponsor requires automatic reordering for unusable medication or prefers that to be a manual step they control, Perceptive’s RTSM can facilitate that, tailoring every transaction to the study team’s needs and processes.

There are specific challenges in each type of personalized medicine trial, with different needs for cell and gene therapy (C&GT) and for radiopharmaceuticals and nuclear medicine, where expiry management is to the hour. A customizable RTSM can support the site with not only visit scheduling and time management but with calculating the volume for administration, correcting for radioactive decay based on the number of hours from calibration time.

A tailored IRT can even be used to support challenges outside of an RTSM’s core function: as a communication system to support effective cross-team communication and provide alerts to manage risks ahead of future events. The system can be used to highlight and control strict time windows, such as tracking dates and times from manufacturing to confirmation of shipment receipt and controlling when personalized medicine may be used.  It is important to assess how the IRT can best support the process at each step. Careful consideration of the IRT position in the site process will highlight the best use: to enforce small time gaps, or simply alert or provide advice in cases where there is a delay between IRT dispensing and patient use.  A ‘dose confirmation’ transaction may also allow the IRT to adapt to the changes in visit and dosing schedules following an unsuccessful dosing visit, imperative for personalized medicine trials, with a range of options relevant to rescheduling site visits (and managing medication production and/or just-in-time delivery accordingly).

These capabilities are a few of the ways Perceptive’s RTSM provides an effective communication mechanism and supports risk mitigation across numerous types of challenging study designs.

Perceptive has seen a change over the last decade in how personalized medicine trials are handled, from study teams asking us to only manage dates and bookings, to asking us to manage the whole chain of events from medication release to individual shipment raising with time window checks. Our IRT has been used as a planning tool, as a manufacturing capacity management tool, and as a tool to track and dispense personalized medicine.

Our message is that an IRT can do much more than randomization and trial supply management and a system which can be tailored can support specific challenges.

Engage early with IRT/RTSM experts to ensure the system can meet your personalized/precision medicine challenges.

[i] “Personalized Medicine at FDA: The Scope & Significance of Progress in 2023.” Personalized Medicine Coalition, 2024. https://www.personalizedmedicinecoalition.org/wp-content/uploads/2024/02/report-3.pdf