Outsourcing
Comparator studies require meticulous planning to ensure effective distribution and minimal waste.
“The most important areas of expertise in a sourcing partner are, firstly, broad sourcing options, with primary, backup, and tertiary options for each critical comparator,” says Rose. “Secondly, they need a global presence with local knowledge in key study markets; and thirdly, they need regulatory and importation expertise.”
However capable the sourcing partner, they can’t guarantee that unforeseen circumstances won’t arise. What they can do is to make sure they aren’t blindsided. Whatever happens (be it pandemic or political turmoil or permit issues), they need to have a plan in place to ensure the continuity of supply.
“The most important areas of expertise in a sourcing partner are, firstly, broad sourcing options, with primary, backup, and tertiary options for each critical comparator; secondly, they need a global presence with local knowledge in key study markets; and thirdly, they need regulatory and importation expertise.”
“Careful risk assessments and the establishment of mitigation plans by industry experts is the best way to overcome roadblocks and quickly pivot to avoid study disruptions,” says Rose. In short, sourcing partners need to be adaptive, responsive and flexible in their approach – which also means staying abreast of industry trends. One interesting example that Rose flags up is the importance of sustainability within clinical trials. “Excess and waste of comparators are often top of agendas,” he says. “Following Covid-19 there has
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certainly been a shift away from having safety stock, with more clients wanting to understand how we can support them in moving unwanted stock to other channels. We expect that this is a trend that will continue in the future, and we have in place ways to help clients achieve these goals.” This is a sentiment that chimes with the Abacus Medicine Pharma Services survey. Several respondents said they were sourcing smaller quantities of comparators more frequently, as opposed to sourcing large quantities upfront. ‘Wastage’ emerged as a leading answer, when respondents were asked how compactor sourcing could impact a clinical trial. Rose adds that, while Clinigen itself has managed to avoid most supply challenges, the company is very attuned to the kinds of impacts they can have on trials. “The most common responses to disruptions are delays, whether that be in terms of patient enrolment, first patient in, or, in the worst case, patient treatment,” he says. “Clearly this is top of mind for the trial sponsor. It’s a key consideration in the development of the trial protocol and the choice of comparator to minimise the risk of disruption, for which we look to lend our knowledge and expertise on the best routes for product.” You might say the goal for comparator sourcing is simple. All you need to do is to ensure that the right quantities of product reach the right sites on time. However, as many sponsors can testify, ‘simple’ emphatically does not mean ‘easy’. Sponsors need to be strategic in their approach from the outset, with a keen eye towards the many risks and roadblocks they are likely to encounter along the way. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
Chay_Tee/
Shutterstock.com
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