Clinical trials are a complex undertaking. Sponsors and study teams are under a high amount of pressure to keep costs and delays at a minimum, but so many pain points make their jobs difficult.
Comparator sourcing is one trouble area well known for causing nightmares for clinical trial organisers. In a 2018 survey by Pharma Logistics IQ, 60% of respondents labelled comparator sourcing as a key stumbling block for losing time and money in clinical trials. We spoke to Abacus Medicine Pharma Services’ business development director Ian Hoban to find out why.
Balancing the numbers
In an ideal clinical trial, sponsors would deliver the right quantity of medicine to study sites with the required documentation and suitable expiry dates. All of this would happen smoothly, without any delays.
This success depends on accurate patient recruitment forecasts and an effective comparator sourcing strategy that enables sponsors to access the necessary product numbers either from the open market or directly from manufacturers.
But patient recruitment rarely goes as planned, with up to 86% failing to meet targets within specified time periods. The global pandemic has only exacerbated recruitment struggles. As new waves of infection come and go, causing subsequent lockdowns that hinder patient recruitment, enrolment numbers are more unpredictable than ever before.
Securing a robust supply of specific medicines is not easy, either. “There have always been big issues around reliability, lead times always being longer than ideal, expiry dates of comparators not necessarily being as long as you’d hope,” says Hoban. “These have been compounded quite a bit since Covid, particularly if you add that to the boom and bust that you get with patient recruitment. If there’s a lockdown, patients generally won’t get recruited and you could be sitting on a large amount of short-dated stock that might never get used.”
Writing off product due to poor expiry dates or low patient numbers is a big cause for concern, particularly considering the high costs of many biologic drugs.
It’s not just the medicine itself that matters. Securing the correct documentation as dictated on the regulatory submission is essential. This is also important for importing and exporting products. Certificates of Analysis are typically needed to move medicine from one market to another. Import licenses are required when moving inventory into APAC from Europe, meanwhile any biologic products being exported to the US must come with documentation demonstrating FDA and Department of Agriculture compliance.
Missing documentation can cause products to be stuck in customs, which not only delays trials but sometimes puts the integrity of the medicine at risk. Even with the correct documentation in place, there is always the chance that products could be held up in random, routine checks.
“If your cold chain product is impounded, you don’t want it sitting in an airport where it’s out of temperature requirements. The very expensive biologics can very quickly degrade out of temperature spec and become unfit for purpose,” says Hoban.
Temperature history must be documented in the regulatory submission to show products have been kept in the required conditions. Backup storage facilities and plug-in ice boxes could be needed to keep products stable in this event.
Sourcing strategy decisions
There are multiple different approaches to procuring comparators, meaning lots of important decisions to make. One misjudgement could have huge implications on the smooth running of the clinical trial and the launch of the new drug.
“There’s usually different options available to the sponsor in terms of how much it might cost them to acquire the comparator. If they choose one with risks associated to it, it could mean a delay or a piece of key documentation that doesn’t arise. The cost savings of the drug acquisition can be very much negated by other costs around trying to patch up the consequences. Every day that’s delayed for a new product launch can cost drug companies a fortune. The sake of saving a few thousand or tens of thousands of euros during comparator sourcing could cost millions or billions later,” explains Hoban.
Developing a sound sourcing strategy is critical but rarely straightforward. Prompted by the supply chain crises posed by Covid, companies are now looking at procuring from an increasing number of sources. “That’s one of the things we’ve been able to help some of our clients navigate,” says Hoban. “They’ve been able to take different elements of sourcing strategies for different parts of the trial to keep a continual flow of products, reduce the risk of outages caused by lead times, and prevent stock going out of date.”
While this hybrid approach addresses some of the key risks involved in a one-stop solution, having more balls in the air can also add new concerns. “It’s got to be done in the right way and it’s got to be done in a partnership way,” says Hoban.
The Clinical Trials Solutions service offered by Abacus Medicine Pharma Services was established to help sponsors navigate these challenges smartly. By analysing real-time data regarding the availability, price, documentation, and lead times of key medicines throughout the EU market, Abacus Medicine Pharma Services develops bespoke sourcing and inventory management strategies that sponsors can trust.
To find out more, download the case study below.