In an earlier blog, we presented how sponsors can minimize the amount of study drug wasted during clinical trials and reduce packing, shipping, and costs by pooling medication kits across a suite of protocols/programs. We shared a range of different approaches which enabled sponsors to pool medication effectively, discussed options with limited impact on the IRT set-up, and shared the rules to consider to achieve maximum benefit.
Here we answer common questions about medication pooling and how the RTSM experts behind Calyx IRT can help you determine if you can realize its benefits for your development program.
Is medication pooling very difficult to implement?
Not necessarily. Over the past few years, we’ve learned a lot from our clients about their pooling needs and are now helping sponsors implement what we’re calling an ‘entry-level’ pooling method, which is less complex as it only requires some small tweaks to their IRT functionality.
This simple pooling solution gives the drug supply manager full control over what they are releasing and where. It simplifies the medication release process by removing specification updates or the need to upload additional portions of a central program packaging list into the IRT system. With this simplified approach, all of this is now done in one central IRT area that can then automatically feed into all studies in the program.
This simple addition to your IRT set-up means you don’t have to interact with the individual studies to provide another portion of the packaging list or in the worst-case scenario, to upload the whole list into all the studies within the suite, which has its own risk (where the same kit could be released into multiple studies).
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Medication Pooling: Minimizing Regulatory Risk and Realizing the Benefits.
Are supply managers seeing the expected benefits of medication pooling?
Yes, but it depends on the method that’s being used, and keeping in mind the increased complexity of implementing something like just-in-time delivery. For example, supply managers have told us about challenges they’ve experienced related to their depots not being able to facilitate as much of the just-in-time labeling as was initially planned; this limits their ability to see the full benefit.
We’ve also heard from some clients who have tried other complicated pooling options that their expected return was not fully achieved. This does not mean that there was no benefit, it’s just that the benefits are more likely to be tied to the designs of the trials being pooled instead of solely the use of pooling functionality.
What study designs and supply chain approaches allow us to see the benefits of pooling?
We ran simulations to understand which standard study designs could achieve the 40% reduction in drug wastage that’s been reported. The scenarios which resulted in the biggest reductions were:
- Trials being run in the same locations at the same time with the same medication types
- A program targeting different populations of patients within the same countries
- Trials using the same depots
The same style of protocol could produce a large benefit in comparison to protocols engaged in different, mutually exclusive countries that do not share local depots. As soon as you introduce different depots, you’re not sharing the depot stocks in an efficient way and the benefit is reduced.
Can your RTSM consultant team help us understand if we can benefit from medication pooling?
It’s important to note that a range of methods are available to you: pooling and JIT’s simplest form may not or may only minimally impact IRT/RTSM set-up and reduce concerns about regulatory approvals.
This is why it’s important to engage early. Calyx trial supplies consultants will help you explore pooling opportunities, review how to increase its benefits, and support just-in-time labelling.
A member of the expert RTSM team is assigned to every study and remains assigned to consult until its closure, however you don’t need to wait to engage with us. If you have been considering pooling your medication across a program of studies, we’re more than happy to discuss solutions.
If you’ve not had your labelling approved and you’re looking for other options, we’re also happy to provide further detail of what we’ve seen around just-in-time labelling.
If I’m running one study and want to pool a planned study with it, can this be done?
It would be ideal if you knew in advance, as you could set up the IRT system alongside the first study. But we know that’s not always possible. If you want to add a second study, some changes will need to be made to your ongoing study to create an overarching ‘parent study’.
Creating the parent study is not the same as a standard IRT build, as its primary function is only to hold the packaging list and facilitate the sharing of the kit list at the right time; it’s just a release facilitation tool.
Once the parent study is created, adding a third, fourth or fifth study is not an issue, because the framework is already set up.
If you are planning on pooling, you’re likely having that discussion early on so that shouldn’t impact IRT in this situation. This is another example of why early engagement is so important.
