IRT and temperature excursion management systems have not been traditionally linked together. IRT originally focused on patient randomization and drug supply management. Temperature management for drugs in shipments and at sites has historically been a manual process. With no way to automatically tell the IRT to stop assigning the concerned drug kits to patients, it has been a slow and often error-prone process.
Suvoda gathered a panel of drug supply chain and logistics experts to talk about the benefits and challenges of integrating digital controls and processes into their temperature excursion management activities. They also discussed the challenges of integrating direct-to-patient shipments into clinical trials with temperature-controlled elements. Lastly, the panelists gave advice to sponsors and clinical teams looking to automate or otherwise digitize their temperature excursion management processes.
Our panelists included:
- Mary Pat Walsh, Associate Director of Clinical Supplies, Endo Pharmaceuticals
- Ayelet Weissbach, Clinical Supply Chain Manager, NeuroDerm
- Henk Dieteren, Supply Chain Solutions Consultant, Suvoda
- Harald Van Weeren, Clinical Trial Segment Manager, Berlinger
When integrating temperature excursion management systems into IRT, they described the following potential challenges, benefits and general advice to sponsors:
Advice to sponsors
Benefits of Digital and Automated Solutions
IRT has increasingly incorporated supply chain controls and end-to-end visibility into its systems. It is therefore a logical step to integrate temperature excursion management systems with IRT. With this kind of integration, site users can automatically upload logger data into the temperature management system. The temperature management system tells the IRT if excursions occurred or not, and the status of drug kits are automatically updated in the IRT based on the rules specified by sponsors.
The result has been a reduction in the number of challenges traditionally seen in manually managing clinical cold chain logistics. In discussing the benefits and challenges of integrated temperature excursion management, it’s clear that automation is a clear winner over manual and paper-based processes.
When a temperature excursion occurs, the time between an excursion occurring and for clinical teams to become aware of it is critical. Henk described the experience that inspired him to seek an automated process. He recalled the difficulties in using a paper-based process while serving in a supply chain role at a pharmaceutical company. “It took a long time to find out about excursions and to verify they had taken place,” he said. His team would also often discover through verification that the information they had was incorrect. He conducted an analysis of 4,000 shipments that showed he and his team had an average of 29 days before they could release the medication that was quarantined.
Ultimately, it led him to seek out Suvoda, Berlinger, and a depot software vendor to create a solution to automate end-to-end temperature excursion management. The solution reduced their processing time from 29 days to less than one, and led to reduced quarantines for drug shipments by 89%.
Improved Safety and Efficacy
The reduced time needed to register temperature-controlled shipments can have other benefits. Mary Pat explained that quicker processing times can contribute to patient safety, “because if there’s an excursion, we can make a decision sooner on whether the IP is still safe to use or not.“ This helps certify internally valid trial results by reducing numerous downstream effects to studies associated with impacts to patient safety and drug efficacy.
Reduced Manual Error
If site users record the wrong temperature data, if they are off by a decimal point, or record the wrong time the excursion occurred, this can skew the accuracy of the data and could possibly lead to unnecessary drug wastage. Ayelet remarked that implementing a more automated solution increased her confidence. “I feel a lot better knowing that all the site users need to do is upload the logger data and I can trust the system to make the decision.”
Better Inspection Readiness
Clinical teams can rely on a digital solution to neatly centralize all their data in a cloud-based repository of files for easy reference during audits. Automated temperature systems also give a clear yes/no answer to whether an excursion occurs based on the most current stability data the sponsor has. Harald explained, “It can give teams the confidence to quickly and easily specify to auditors that no excursions have taken place. Whereas with manual processes, teams can spend days to weeks digging through their data to confirm this information.”
How to Integrate Digital Temperature Management
Our webinar panelists advised sponsors that planning, flexibility, training end users, and seeking feedback from sites were top considerations when implementing digital and/or automated temperature excursion management. Ayelet stressed flexibility above all. “Keep all your options open. Think of everything that’s happened and could potentially happen in your trials, and then build a system,” she said.
Training and Feedback
Training and retraining are needed to acclimate site staff to using the new technology effectively. “If the sites don't use the great system that we built, then it is of no use,” Ayelet said. Retraining is important because site staff can forget to upload the logger information into the system. This affects the validity of the monitor data. And if the data of a temperature recording device can not be attributed to specific drug kits or shipments, additional documentation may need to be filled out by clinical staff.
Educating site teams on the gains in efficiency will encourage them to use the system’s full capability. It’s also important to seek feedback on users’ experience with the system, and how to improve its usability. These site users comprise a critical role in monitoring, preventing, and accounting for the temperature excursions of IP, and so their input is just as valuable as the sponsor-led clinical teams that outline the initial requirements for an IRT to fit a protocol’s demands. As Ayelet noted, “A system is only as good as its end users.”
Systems also have to be flexible to allow for manual intervention when necessary to preserve the integrity of temperature data. “There are times where the information that sites provide looks inconsistent or otherwise provokes questions, and you need to get additional information from the site to find out what happened or clarify something,” Mary Pat said. These kinds of stopgaps are critical to efficient trial supply functionality and can serve to further secure the gains afforded by an automated solution.
The COVID-19 pandemic has caused an increased demand for direct-to-patient shipments to keep trials running. Harald explained that he has witnessed how this activity has increased the need for end-to-end monitoring among clinical supply teams.
“As supply managers,” Ayelet explained, “we are responsible for the IP for every leg of the journey until it ends up in the patient’s hands. With this in mind, couriers need to be able to upload the data from the logger into the appropriate system or provide us directly with that information.” She explained that due to COVID-19 restrictions differing across the US, for example, processes can vary across sites. “Whatever approach we take, we have to keep it as flexible as possible so it will fit as many sites or options as possible. Because right now, anything can happen.“
She also added the need to use a central pharmacy to dispense drugs directly to patients’ homes when necessary. “We have the flexibility in our system to shift the responsibility of managing supply from the clinical site staff to the central pharmacy.” “If the site closes,” she continued, “we can reconfigure the system in such a way that the central pharmacy can raise shipments directly to patients’ homes.”
Planning means defining user requirements and must-haves. This is crucial for setting up a functional IRT system, especially one that integrates with automated temperature excursion management systems. “Make sure you have your goals clear in what you want to achieve in end-to-end monitoring. How early and how often do you want to have your monitoring? How does it fit with your current processes?” Harald said. He also stressed that sponsors should evaluate the need for real-time monitoring. Essentially, they should evaluate whether they have the resources necessary to collect, analyze and use the amount of data that real-time monitoring often creates.
The panelists all agreed that the benefits clearly outweigh the challenges inherent in implementing digital and automated temperature excursion management solutions within their trials. With the right planning and participation from clinical teams, they can experience quicker processing times, reduced room for error, greater audit-readiness, and greater patient safety.
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