In this Industry Viewpoint, Clinical Trials Arena editor Henry Kerali sat down with Terry Panayiotou who’s the IWR Manager at Janssen Pharmaceuticals.
Panayiotou acts almost as a point of contact between the trial sponsor and the vendor. He supports both parties ensuring the clinical team gets what they’re asking for and making sure the vendor is able to provide it.
If the clinical team has an issue with the vendor, Panayiotou is there to step in as a point of escalation. In this interview, Panayiotou speaks to CTA editor, Henry Kerali, about some of the challenges he faces working within the clinical supply chain, and in particular, on the use of third party technology.
Clinical Trials Arena: Explain the importance of vendors within the clinical supply chain and their use of technology
Terry Panayiotou: Within the supply chain, the vendors are irreplaceable. Once the IRT systems are up and running, movement of supplies to the sites can operate without anyone having to do anything. That mechanism saves not only a lot of medication for the depots, it ensures there’s always medication on site for the patients. It also provides an abundance of tools for the supply managers so they can release medications specific to countries. If a country isn’t online yet, they won’t have to worry about the system shipping out to that country, unless the supply manager has released it.
Ultimately, the amount of tools a third party system gives a supply manager makes life so much easier for them. The web reports, for instance, allow them to chart the status of all the shipments. The manager whether it’s been sent out, whether they’re still pending or whether they’ve arrived at the site. They can also see the movement of the medication itself from the depot through to the end where it’s either been dosed or destroyed. So there’s full drug accountability in the system, which saves our monitors from having to go from site to site looking at packs, what’s been returned, and what’s left on the monitors as well.
CTA: Why is it important to build awareness within a clinical team about an IRT system that a vendor uses?
TP: In the past, IRT systems have been something a lot of people have feared, with the common perception being the technology would fail on them. It’s very easy to overlook the benefits of these systems and how easy it is to screen, randomize, and view all your subjects. From a GTL perspective, you have web reports where you can see every subject across the world. From there, you can obtain high level reports at a country level, a site level, and even at a subject level where you can see what kit number has been assigned. It gives full visibility of what’s going on in your study, which is not something you would have if you didn’t use this system.
CTA: What should vendor managers consider when overseeing their partner throughout the course of a study?
TP: What’s crucial is that the vendor manager considers what the clinical team needs. From experience, by having preferred providers you know which vendor can support a study better than others. Sometimes there’s nothing in it; they’re both fully capable of supporting a trial, so it’s important for them to look and determine whether there’s a sister study being run, which vendors are they using and so forth. If they are using a certain vendor, determine whether they plan to use the same sites again because life would be a lot easier for sites if they’ve got a system with exactly the same layout.
CTA: How should vendor managers assess the needs of a trial to make sure the clinical team and the vendors have what’s required?
TP: This is an important issue because if you let them, a clinical team will try to capture everything within an IVR system without considering the data is being captured elsewhere. It’s vital to determine what’s worth having within a system, what isn’t and what poses a risk. I’ve had studies where clinical teams wanted an incoming data transfer from the laboratory, and that data would be used to perform randomization. However, that would leave you at risk if the data transfer fails or hasn’t come in. So the vendor manager needs to look at what the clinical team is asking for and assess the risks involved while trying to mitigate it.
CTA: How do you combat situations where an IRT system falters and how do you alleviate the impact?
TP: Firstly, gather as much information as you can; understand what has gone wrong and develop an audit trail. Try to determine whether it’s a user issue (e.g. someone has tried to deactivate a site without the correct access) or a system issue. If it’s the latter, let the relevant people know and glean what the risks involved are, i.e. is there a danger of the subject being given the wrong medication or no medication at all, etc. These problems need to be escalated in order to resolve the matter as promptly as possible. So it’s just a matter of looking into it, getting all the information, and moving forward. There’s no use panicking without knowing what’s wrong.
Ultimately, with any issue that crops up in a trial, communication is the key to everything. If there’s a problem with the system or the vendor, turn to your vendor manager as they’re there to assist the clinical team in resolving the issue.