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that you might have to source several oncology medicines, rather than just one specific drug. Maintaining a continuous supply of these, typically generic, medicines is a considerable challenge. Patient recruitment is already problematical in oncology. In fact, approximately 3% of cancer patients participate in clinical trials despite so many being conducted. This means high levels of competition when it comes to finding eligible patients. Any delays in medication procurement push trial timescales further back, potentially meaning recruited patients missing treatment windows and dropping out.
In your opinion what are the future trends for trial supply for oncology studies? Remote trials benefit from a number of key technologies, including electronic applications that guide patients to take the right dose of medicine at the right time. Telemedicine enables easier and more frequent conversations between researchers and patients – meanwhile wearable technologies can also be utilised for automated, digital data collection. Done the right way, decentralisation comes with the potential for patients to be better managed from their own homes than ever before. These sorts of technologies were already there, but in the face of the pandemic they’ve come to the forefront and increased in adoption. The supply chains for test results are a lot better managed than they were pre-Covid. Interactive response technology (IRT) continues to develop too. In oncology trials where there is a need to use injectable medications, such as cytotoxics, there will remain the need for administration by a healthcare professional, but overall these are the trends that I believe will continue to develop in future years as the more modern genetically derived oncology medicines replace the original cytotoxic compounds.
Aposave Annual Survey of Clinical Trial Professionals We know that sourcing of comparators and secondary intervention medicines for clinical trials is not only a significant cost but presents a multitude of challenges to sponsors. In this second Aposave 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.
Survey overview Following on from the first survey in 2020, Aposave repeated the survey in 2021 to help understand how the key issues and challenges faced by global supply chain professionals has evolved in the second year of the pandemic. The survey was conducted during the CTS Europe, GCSG (Global Clinical Supplies Group) and CTS USA conferences between 24 March and 3 August 2021. The survey was completed by 46 delegates, and a copy of the results can be found here:
aposave.com/wp-content/uploads/2021/11/ Annual-CTS-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 community were facing. Several of the answers appear to reflect some of the issues exacerbated by the 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
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