IN PARTNERSHIP
comparator more frequently. This appears to be bucking the historical trend where larger quantities of comparator were sourced upfront and is likely to be a response to some of the previously stated issues, such as poor expiry dates.
Q5: Which of the following issues does comparator sourcing have the greatest impact on during a clinical trial?
Compared to 2020, where all issues were thought to have a similar impact, this year “wastage” clearly had the greatest impact, followed closely by “supply to individual sites”. With many trials facing delays, predominantly due to COVID-19, this is not surprising, and the move towards decentralisation is likely to be a factor behind the second highlighted issue. Specific issues cited where the response was “other”, included: • local pack design availability • lead times/sourcing • demand planning • continuity of supplies; packaging and regulatory considerations
• blinding challenges • overall sourcing
Q6: In the 2020 survey, several factors were identified as the most important when selecting a comparator supplier. We asked the 2021 respondents to tick those that applied to them. As in 2020, “reliability” was the most important factor highlighted, which is not surprising, bearing in mind the variety of pitfalls that can potentially derail any comparator sourcing project. “Price”, appeared to be of higher importance
this year than in 2021, so sponsors are clearly looking to minimise the acquisition cost, which is understandable, just so long as factors like quality and reliability are not compromised as a result.
Q7: The 2020 results showed most respondents had been negatively affected by COVID-19. Have you had to adapt your decision-making and comparator sourcing strategy as a result? Just under 35% of the respondents said they had to adapt their decision-making and comparator strategy because of COVID-19. However, this does mean it probably necessitated a change in approach to a significant number of clinical trials.
Q8: If you answered yes to Q7, please give one example.
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Those respondents who had to modify their decision-making and strategy in response to COVID-19 gave a variety of examples, including building inventory, actively managing stock into sites only where there was a demand, increasing frequency of purchases to maintain supply of COVID-19-restricted medicines, delay or extend the timelines, and supply chain/sourcing strategy diversification. Flexibility and pragmatism both appear to be common themes throughout.
Q9: Do you believe that any of your clinical trial comparator inventory is at risk of write-off due to COVID-19 disruptions?
A sizable 80% of respondents did not believe that their comparator inventory was at risk. This was a small increase from 2020, where the figure was 75%. We can take a couple of conclusions from this: first, it is known that write-off costs are typically high, even without the backdrop of a global pandemic; and second, adaptations have clearly been made in response to COVID-19 to mitigate the risk of wastage, which is something that Aposave plans to explore more deeply with our 2022 survey.
Company comment
There is no surprise that participants in this year’s survey are dealing with many of the perennially documented issues that sponsors face when sourcing comparators for clinical trials. It is even less surprising that many of those
surveyed have reported first-hand experience of additional and amplified issues manifesting as a direct result of the pandemic. This was found to have frequently resulted in a change of approach by the trial sponsor. In summary, a few themes emerged from the 2021 survey: • balancing the risk of supply shortages against wastage
• balancing comparator acquisition price against reliability
• increased pragmatism and flexibility • sourcing smaller quantities of comparators more frequently
Overwhelmingly, the key strategy being adopted
by the majority of companies is to work strategically with supply partners who are reliable in what is an increasingly unpredictable and challenging environment.
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