In certain situations, sponsors may need to consider drug supply pooling for their larger program level drug studies. This can allow them to consolidate supply lines and cut costs. So what exactly is drug pooling and what does it mean for IRT? Drug pooling is the ability to provision drug supplies between a central depot to multiple protocols. Drug pooling allows IRT drug management to supply multiple studies from a central drug schedule simultaneously. To do this well, the IRT drug management needs to be sophisticated enough to balance supply settings across multiple trials while applying them to a central supply source.
There are many important considerations when contemplating drug pooling needs. The most important are choosing the right company to handle your clinical trial supply management (or having the proper resources in house) and choosing the right IRT technology partner with the appropriate level of experience along with a robust IRT system.
There are many factors to consider when implementing drug pooling.
For example:
When setting up an IRT system for drug pooling, there may be some kit types used that will not be required for every trial drawing upon the pooled supply of drug. The system and study designs need to be intelligent enough to ignore unused kit types. Also consider that kits may be used by different countries with different import regulations. Some countries may allow supplies to be imported within 90 days of their expiry date while other countries may require supplies being imported to be a year or more from their expiry dates. To accommodate this, Do Not Ship, Do Not Count and Do Not Dispense settings need to be set at the study level and applied to a common batch associated with pooled supplies. Drug releases for pooled supplies are also more sophisticated as certain ranges of kits may be released sooner for one study than others. Therefore it is critical to ensure that the kits being released are only truly available for the study that the release is related to. Complexities like these make it important to choose an IRT system that is appropriately designed to handle drug pooling.
There are three main types of drug pooling
1) Pooling prior to labeling
2) Pooling at the depot:
Where kits reside at the depot without any specific protocol number and the protocol is added when the kits are shipped to the site.
3) Pooling at the sites:
In this scenario, the protocol is assign to the kit as it is dispensed to the subject. Pooling at the site level is very complex and faces many regulatory hurdles.
In this blog, we are going to focus on drug pooling at the depot level. It is important to have reports that view drug supply at the study program level in order to track the central pool of supplies. Study level reporting also need to give detail on the kits and their disposition once they have been requested and are associated with sites and subjects. Leveraging the reporting power of the IRT database in combination with IRT data transfer to the drug depot is vital to the success of the clinical supplies management team.
Drug pooling offers a cost effective way to streamline supply chains in clinical trials, reduce waste and increase flexibility.
It should be a deciding factor in IRT system design when being applied at the program level. Insight is critical and when well designed reports are in place the benefits of this method of clinical supply management are clear.
Eclipse IRT was designed from the ground up to support drug pooling. Please feel free to Contact us if you would like an in-depth demonstration.
