Outsourcing
Then there’s the question of how much product to obtain. Do you want to purchase large quantities (which means thinking about manufacturer lead times and product shelf life), or only acquire as much as you think you’ll need (which means having none in reserve)? These kinds of questions apply not just to the drug itself, but also to items like infusion kits, needles and syringes. Depending on the trial in question, you might be tasked with sourcing a range of ancillary supplies.
“Comparator sourcing has always had a focus on flexibility and adaptability, but the move towards globalisation and decentralisation will push this further,” says Rose. “We certainly see that it is creating greater complexity for the sponsor to manage.” The stats here speak for themselves. According to Almac Group, 60% of sponsors have identified comparator sourcing as a key stumbling block for losing time and money in clinical trial supply. Another survey, by Abacus Medicine Pharma Services, found that lead times and speed of sourcing were consistently among the top three challenges in this domain.
This is especially the case for clinical trials taking place in emerging markets. Currently, there is a clinical research boom under way in places like the Middle East and Africa, which has the advantage of cutting drug development costs and opening the trial to a larger population. On the flip side, it can pose a headache in terms of comparator sourcing.
Geopolitical challenges
Whatever the precise challenges a sponsor faces, they can’t get round the fact that they’re dealing with many unknowns. Despite their best-laid plans, things can go wrong at any moment, ranging from supply chain hiccups and regulatory changes to total export bans. “We’ve seen factors like the crisis in the Suez Canal and export bans impact the availability of product and require the sourcing of alternatives, often which are hard to find owing to the narrow field of options that fit all the trial criteria,” says Rose. The Covid-19 pandemic was a case in point. In the 2020 Abacus Medicine Pharma Services survey, nearly a quarter of respondents believed that some of their clinical trial comparator inventory was a write-off. A year later, nearly 35% of respondents said they’d had to adapt their decision-making and comparator strategy because of the pandemic, with actions such as delaying timelines or diversifying their sourcing strategy. In Rose’s view, the most significant impact from Covid-19 was that key resources were diverted away from non-Covid-related trials.
Clinical Trials Insight /
www.worldpharmaceuticals.net
“For the ongoing studies there were struggles in accessing products which had been previously readily available, owing to a delay in shipping or because the product was being used in Covid treatment,” he says. “For new studies, there were significant delays to the launch, which we saw take a considerable amount of time to come back.” Another big issue over the past few years has been Brexit, which has made it harder to move goods across the UK border. As of January 2021, many branded medicines that were placed on the UK market are no longer available for export to countries in the European Economic Area.
Unlike many standard clinical trials that compare investigational compounds with placebos, comparator studies test drugs against existing treatments.
“Comparator sourcing has always had a focus on flexibility and adaptability, but the move towards globalisation and decentralisation will push this further. We certainly see that it is creating greater complexity for the sponsor to manage.”
“A shift we have seen over recent times is a shift away from the UK following Brexit,” says Rose. “Whereas in the past the UK has been a really strong source of comparator material for clients, that has largely stopped now with the regulations in place stopping UK product being able to be used widely.”
How to manage the risks With so many different factors at play, it is not surprising that sponsors often seek to outsource their comparator sourcing to third parties. Although outsourcing can pose its own challenges (think security concerns and added delays), many choose to work with trusted clinical supply partners with a specialism in the field.
60% Almac Group 33
The percentage of sponsors citing comparator sourcing as a major reason for losing time and money in clinical trial supply.
Motortion Films/
Shutterstock.com
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