Clinical supplies & logistics
to have a flexible system in place allowing you to switch per site if you want to have direct-to-patient shipments,” says Dieteren. Being able to monitor and switch between different visits means the supply manager can adjust the strategy in real time and as needed, he explains.
Patient safety
Although automated temperature monitoring is yet to be industry standard, it can allow IRTs to instantly block drug assignment if there is an excursion, reducing the risk to patients. Dieteren spearheaded the development of the very first automated temperature monitoring process after noting the risk to patients that comes with more manual procedures.
In a manual scenario, the IRT would be in place, but staff would need to physically receive the data logger for that shipment, and an alarm could be triggered if there was an excursion. The risk is that the IRT wouldn’t necessarily receive this information and therefore could still assign the medication, and the team could then accidentally dispense it. “You may be aware as a sponsor of a potential temperature excursion. But if there’s a different team handing over medication to the patient, not being aware of a potential excursion, this is a certain kind of risk,” he says.
Excursion profiles, and the concept of a remaining excursion budget, can also allow for more accurate insight on investigational medicinal product (IMP) safety. This refers to the total amount of time a product can be held outside of ideal temperature conditions before it then needs to be quarantined. “Today, the expectation is, in all the different stages of manufacturing, storage, and distribution, that there needs to be control of temperature. It’s not only in the shipment,” says Kappelle. Considering the cumulative effect of all these potential excursions is already an industry expectation, but this is often difficult to monitor, he adds. “Sponsor companies are having massive challenges with that because they are working with disconnected systems – they need to go to all these different systems to figure out what happened to this product.” This can be tricky for busy sites, too. “Everyone is so overloaded with systems it can be a challenge to negotiate with sites or other vendors,” says Schiavon. “Sites often don’t know what drug is showing up on a certain day, which can be a problem if they get a lot of shipments and with different temperature requirements.” IRT integrations can make this easier but there’s still room for improvement in linking different systems from clinical teams, sites, and depots.
Clinical Trials Insight /
www.worldpharmaceuticals.net
Looking ahead
IRT has already been a game changer for clinical supply chains, but as technology develops and trial requirements become more advanced, it holds even more potential. For one, IRT could help to enable temperature control over the lifecycle of a product, and act as a centralised hub for all the important data about that IMP. Unit-specific tracking and measuring capabilities will be key here, says Kappelle. “There’s good examples of that technology already in the industry. But it’s early days, and the technology needs to improve – particularly, the reliability of these individual measuring units on the kit need to improve.” The industry may also look to blockchain technology to help deal with systems overwhelmed with data, says Schiavon. “I think blockchain is a really interesting opportunity to alleviate that burden, there is buzz generating more now about blockchain technology in drug supply management.”
Automated temperature monitoring is yet to be industry standard, but it has potential to reduce the risk to patients.
“I wouldn’t like the courier in front of me to open up my package and take something out. And the second thing is that, for a couple of hours, I don’t know if the product is good to use or not.”
Jan Pieter Kappelle
In theory, using blockchain could create an audit trail of a drug’s journey that is recorded into a secure ledger, and sensors could be incorporated so that temperature and humidity are noted at each stage. For Dieteren, IRT temperature control capabilities will need to be able to support increasingly complex trials where treatments are patient-specific, and drugs are manufactured on-demand. As we move in this direction, it is important to anticipate both the needs of the sponsor and the patient, he adds. “You need to put the patient in the middle, and first of all, know the disease. Then we can ask: ‘How can we treat the disease better?’ And from there, we can start to talk about what we need to develop that drug.” ●
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sfam_photo/
Shutterstock.com
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