Part 1 – Central vs. Local Medication Sourcing
The randomization and trial supply management (RTSM) needs of clinical trials are complex. But, sponsors who leverage robust interactive response technology (IRT) systems can tackle the complexities – often without knowing they exist – in even the most complicated study designs, those involving oncology treatments.
There are many RTSM challenges in oncology trials, including the inherent unknowns regarding the number of visits each patient will complete, the need for different visit schedules per arm (as well as the difference between visits and cycles), and the topic we cover here: central vs local sourcing of standard-of-care treatments.
“Inappropriate medication checks can be detrimental to the course of the trial, as they could result in a failed patient visit.”
— Malcolm Morrissey, Head of Statistics & Product Support Services, Calyx
Tracking Different Medication Types
Multi-center oncology studies recruit across many countries and may require the management of many different medication types, as patients receive the standard of care treatment for their diagnosis in addition to the investigational medical product (IMP). The sourcing of standard-of-care treatments can differ based on each site’s location and may vary from IMP that’s sourced centrally. Sites in one country may need the IRT system to track and manage stocks of centrally sourced treatments, whereas sites in another country may be able to buy sufficient stocks locally.
In the scenario where medication is locally sourced, the labels on that medication do not include unique kit numbers that are identifiable by the IRT system. So, while the centrally sourced medication labels include specific kit numbers assigned to subjects, dispensing information, and expiration dates that are maintained in the IRT system, the same is not true for locally sourced medications.
|Local Sourcing||→||Medication that is not uniquely labelled and is
not allocated by IRT (assumed available)
|Central Sourcing||→||Medication that is uniquely labelled and is assigned
by IRT (specific kit numbers assigned to subjects)
In some circumstances, medication sourced locally could be labeled and released into the IRT or, alternatively, the medication could be released into the IRT as a pure “quantity” of non-uniquely labeled kits via dummy kit numbers. However, these options are not generally utilized, as they assume the medication is stored at a central depot. Shipments to the sites may not be required when the medication is truly sourced local to the site.
Other solutions may be investigated, such as a stock level adjustment transaction to update the IRT with local site stocks. However, the risk of non-compliance may negate the benefits of its application. Instead, the most common case is that medications sourced locally are handled external to the IRT entirely for shipping and dispensing considerations.
When this becomes challenging is at the beginning of each medication assignment visit, the IRT conducts a medication requirement check to ensure that suitable medication is available on-site for a successful visit. If medication is sourced locally and not tracked in the IRT, it will not be included in these checks, and is assumed to always be available.
Inappropriate medication checks can be detrimental to the course of the trial, as they could result in a failed patient visit if the medication that the IRT does not track isn’t available. It could also result in a skipped randomization record and forcing to the treatment that we assume is always available, in the case where forcing is allowed and the medication type we track is depleted.
Oncology trials are typically very long, with patients remaining in the protocol until disease progression. Monitoring patient progression will be a key focus and there could be an extension of the IRT visit schedule to accommodate survival beyond initial expectations.
In addition, the longer the trial, the more likely that circumstances will arise dictating changes in how medication is sourced. This could occur if the availability of the locally sourced medication changes, for example, the need to centrally source is removed through greater local availability of the standard of care treatment, or alternatively, the local source has become scarce or burdensome for the sites to source. And/or the country could also need to change from local sourcing to central sourcing or vice versa for an individual medication type during the live study.
Any change to medication sourcing will have an impact on medication checks, IRT dispensing schedules, visit reporting information, and shipments to sites; if not managed well, the IRT could resupply sites with kits they do not require, which contributes to excessive drug wastage, or alternatively fail to supply the medication that is needed by the site.
The Need for Flexibility
It’s important that your IRT system has the flexibility needed to accommodate central and locally sourced medication, as well as supply changes that can occur during lengthy oncology trials.
Calyx’s IRT solution can apply both central and local sourcing within the same trial and is adaptable to switch on a per-kit type basis within a country from central to local sourcing (and vice versa) during lengthy oncology trials. When sourcing is switched for an individual kit type within a country, Calyx IRT also automatically changes all the associated functionality discussed, which avoids the need for clinical supply manager action &/or programming changes.
Successfully used in over 600 oncology trials to date, Calyx IRT conducts intelligent medication checks during dispensing visits to avoid “false” failed randomizations and is designed to distribute all remaining kits at sites before switching to local sourcing to reduce excessive medication wastage.
Learn additional RTSM challenges inherent to oncology trials. Read Part 2 of the series, ‘How to Successfully Plan and Track Patient Visits‘