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Clinical trial comparator challenges in 2021


Ian Hoban, business development director for clinical trial solutions at Abacus Medicine Pharma Services, discusses its Annual Survey of Clinical Trial Professionals, and identifies some interesting trends.


cost but presents a multitude of challenges to sponsors. In this second Abacus Medicine Pharma Services survey, we have sought to identify the key challenges clinical supply professionals have been facing, how the COVID-19 pandemic has changed the landscape and what tactics and strategies have emerged to tackle this hugely challenging environment.


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Survey overview Following on from the first survey in 2020, we repeated the survey in 2021 to help understand how the key issues and challenges faced by global supply chain professionals have evolved in the second year of the pandemic. The survey was conducted during the CTS Europe, GCSG and CTS USA conferences between 24 March and 3 August 2021. The survey was completed by 46 delegates, and a copy of the full results can be found here: https://abacus medicinepharmaservices.com/wp-content/uploads/ 2022/02/AMPS-Annual-Survey-Report-2021.pdf


Q1: What are the top three challenges you face when sourcing comparator drugs? For the second year, the same challenges were most widely reported. Interestingly, expiry dates were seen as a more frequent challenge than in 2020. We believe this was predominantly due to reduced patient recruitment leading to slower than anticipated consumption of comparators.


Q2: For your most important challenge, please describe in one or two words what this means. We set this more open question to try and get into the detail of what issues the global clinical supply


24 | Clinical Trial Supply Handbook


e know that sourcing of comparators and secondary intervention medicines for clinical trials is not only a significant


community were facing. Several of the answers appear to reflect some of the issues exacerbated by the COVID-19 pandemic: • COVID-19-imposed restrictions to availability


• trial delays • balancing safety stock and waste • unpredictable lead times • interrupted supply


Q3: In the 2020 survey, 65% of respondents stated that the most important way of reducing risk associated with clinical trials was by taking a strategic approach. We asked if the 2021 respondents agreed with this. Unsurprisingly, 87% of respondents agreed with the strategic approach.


Q4: If you answered yes to Q3, please describe one of the strategic approaches you would take? As with Q2, this open question generated a wide variety of responses, possibly reflecting the diversity of the companies surveyed. However, there was one interesting strategic approach that emerged, namely sourcing smaller quantities of 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


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