Clinical supply & logistics
controlled clinical supply shipment, but that could only ever be a short-term stopgap. Wanting trials to continue, where possible, the industry faced an immediate challenge – how to get IMPs to patients without contact and without the usual delivery mechanisms – and better communication and collaboration became the only way to identify and mitigate risks in a rapidly evolving situation. “One of the biggest challenges was that every country was impacted by Covid-19 in a different way and at different times,” remarks Aaron Steinbrecher, clinical supply project manager at AbbVie. “With country borders closing unpredictably, we had to solve how we were going to continue making our shipments. To navigate these challenges during the pandemic, we stayed in constant communication with our site monitoring and affiliate groups, held more frequent team meetings and adjusted shipment timelines on a day-by-day basis.”
Direct action
For some sponsors, the existing mechanisms were sufficient to ensure that supplies flowed in the early days. Ultimately, however, collaboration with logistics partners would prove crucial to their ability to adapt and overcome the challenges of a world in lockdown. “We use third-party depots (TPDs) to supply sites in certain countries,” explains Steinbrecher. “TPDs ensure that IMP is already in the country and can be released when sites require resupplies efficiently. During the pandemic, countries where we used TPDs enabled AbbVie to easily ship released IMP to sites when needed, avoiding the shipping and customs roadblocks that intensified during the pandemic.” For some, the direct-to-patient model of IMP delivery would become increasingly important. Normally the preserve of mid-sized pharmaceutical companies, this is a model being adopted – or at least examined – by larger companies. While a patient might visit a clinical site for the first consultation, thereafter IMPs are delivered direct to them by courier. “Decentralised trial regulations are in place here in the US and in Europe, so we were already seeing a switch to telemedicine, videoconferencing and smartphone apps to replace site visits,” explains Jacobs. “With the pandemic, we had to switch to that overnight, so the direct-to-patient model is growing exponentially.”
One advantage is that this model is less disruptive to the lives of patients who may live a long way from a clinical site. Ultimately, this may help retention and reduce costs. On average, every patient who drops out of a phase-III oncology trial costs $43,000 to replace, according to GCSG.
“Direct-to-patient supply models improve trial enrolment and ease the burden on patients to travel to
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trial sites for drug dispensation,” adds Steinbrecher. “In addition, it reduces the need for site personnel to receive and dispense drugs. While it is more convenient for the patient when the trial protocol allows, it is a more complex model to set up from a shipping and interactive response technology (IRT) perspective. However, it can be extremely useful, as we saw during the height of the pandemic, as well as in rural areas where clinical trial access is often limited or when a drug can be self-administered.”
For the model to work, logistics partners had to step up with fast-response teams to meet the growing demand and, according to Jacobs, they did an amazing job of helping trials to continue and reducing the risk of wasted IMPs.
“An incredible number of studies were able to continue,” he remarks. “One large company had to put $6bn of clinical studies on hold while it checked all of the perceived problems with state laws – even though there were none – but mid-sized companies were able to quickly adopt the model.”
“One of the biggest challenges was that every country was impacted by Covid-19 in a different way and at different times.”
Aaron Steinbrecher Waste not, want not
The experience of the pandemic has cast the broader issue of waste in the supply chain in a new light. “Expiring material is a challenge the industry faces, as it often has to be returned or destroyed at depots, causing waste in the supply chain,” says Steinbrecher. “By using new technology, such as integrated inventory and packaging management systems, we can better predict subject enrolment across countries, and more accurately package and ship IMP to these depots and sites to reduce waste.”
It is not unheard of for sponsors to have a 100% overage for clinical supplies. That kind of surplus of inventory goes a long way to ensuring patients do not miss out on drugs or face delays, but it is very wasteful. Better controls can cut this waste dramatically. “There is better analysis of enrolment at clinical sites now, and we can use a pull model,” says Jacobs. “Patients can be randomised and then given their doses a few days later, instead of doing dosing immediately. That way, you can plan the delivery of drugs to the necessary sites.”
“Clinical trials have been using the push model for 50 years – like sending lots of produce to a supermarket and keeping it in a giant storage area hoping that someone will buy it,” he adds. “Drugs used to be relatively cheap, so that worked, but today’s
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