On an increasing basis, clinical trials use comparator medicine to determine the effectiveness of a drug candidate against the current best treatment option for that indication. This way, every enrolled patient receives the same standard of care, an appropriate leading brand, or investigational medicine – an important ethical consideration in, for example, an oncology trial, where a no-treatment or placebo arm is rarely permissible.
While comparator trials are becoming standard in the clinical trial world, most sponsors can agree that they add certain supply chain challenges. Namely, the often complex process of comparator sourcing is introduced. In an oncology trial, there is often a need for various medicines to be sourced depending on the standard treatment regimen for that particular tumour.
For the past two years, clinical trials service provider Abacus Medicine Pharma Services has held an annual survey to understand the key issues and challenges faced by clinical trial professionals in the comparator sourcing area – many of which have been exacerbated by the Covid-19 pandemic.
The first edition of the survey drew responses from 40 individuals representing 23 pharmaceutical and biotechnology organisations via the company’s virtual booth at the GCSG 2020 conference. The following year, a total of 46 surveys were completed via Abacus Medicine Pharma Services’ booths at the CTS Europe, GCSG and CTS USA conferences in 2021.
In 2022, the company began collecting responses for the third edition of the survey at CTS Europe in March. Ahead of this year’s results, we take a look at the responses from the previous years’ surveys to draw conclusions on the issues sponsors face in comparator sourcing.
The first aim of the survey was to find out what respondents believed was the biggest comparator sourcing challenge. ‘Lead times’ and ‘speed of sourcing’ made it into the top three both years, reflecting the pressures faced by clinical trial teams to keep studies running on time. In 2020, ‘guarantee of supply’ was included in the top three – perhaps reflecting the product shortages faced by many at the start of the pandemic. Interestingly, ‘expiry dates’ rose higher up the ranks the following year.
In the 2020 survey, 65% of respondents stated that the most important way to reduce the risks associated with sourcing comparators was through a strategic approach. 87% of the 2021 respondents agreed.
Respondents were then asked to describe one of the strategies they would take. Answers were varied. One interesting approach that emerged was the sourcing of smaller quantities of comparators more frequently. This bucks the historical trend of sourcing large quantities of medicine upfront and is likely to be chosen as a way of mitigating problems with expiry dates.
The survey also asked respondents which issue (out of a list of options) comparator sourcing has the greatest impact on during a clinical trial. In 2020, ‘compliance challenges’, ‘supply to individual sites’, ‘packaging’, and ‘wastage’ were each thought to have similar impact. In 2021, however, ‘wastage’ emerged as the greatest impact of comparator sourcing, with ‘supply to individual sites’ a close second. The move to decentralisation is likely to be a factor behind the second highlighted issue.
Next, the survey sought to find out which factors are most important to clinical trial professionals when selecting a comparator supplier. Both years, ‘reliability’ was selected as the most important. One difference observed in the 2021 responses was the increase in respondents who selected ‘price’ as a key factor. This is understandable, ensuring factors like quality and reliability are not compromised as a result.
The 2020 edition of the survey showed that the large majority of respondents felt that their patient recruitment and retention had been negatively impacted due to the Covid-19 disruptions. Almost 25% believed that some of their clinical trial comparator inventory was at risk of write-off as a result. In 2021, this decreased to 20%.
Meanwhile, just under 35% of 2021 respondents said they had to adapt their decision-making and comparator strategy because of the pandemic. Those that did gave a variety of examples, including building inventory, actively managing stock into sites only when there was a demand, increasing frequency of purchases to maintain supply of Covid-restricted medicines, delaying or extending timelines, and supply chain/sourcing strategy diversification. Flexibility and pragmatism both appear to be common themes throughout.
The Covid-19 pandemic has held a lens over many of the commonly faced issues associated with the sourcing, supply and distribution of comparator medicines, where they have manifested more frequently in this “perfect storm” environment.
The 2021 survey in particular has highlighted the need to take more calculated risks and innovate proactively to maintain supply to patients, rather that waiting to react to issues as and when they arise.
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