Virtual clinical trials are here to stay’ was the key theme of a GlobalData presentation to delegates at the 11th Annual Clinical Trial Supply Nordics conference being held in Copenhagen from 24-25 October.
Director of therapy research & analysis in medical devices for GlobalData, Andrew Thompson, detailed how since 2019, the number of virtual clinical trials (VCT) has quadrupled, with initial figures more than doubling in the first year of the Covid-19 pandemic.
He detailed how GlobalData analysis had found that around 80% of clinical trials fail to meet their enrolment deadlines. It also showed that for every day of delay, there could be average costs per trial of $8m.
However, despite a rapid uptick in the number of virtual clinical trials being run, there are still some significant challenges in the space that have kept VCTs from being fully adopted across the industry.
Thompson said: “Some of the challenges when conducting new virtual trials are to do with new technology as well as regulatory issues. There are differing regulatory guidelines in each region, in Europe GDPR can present a problem, but in other countries such as the US and China there are different frameworks.
“But also when you start using digital data you also introduce more commercial concerns, like commercial confidential data. There is also the high initial set up costs of setting up clinical software and devices.”
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One such hurdle is that of obtaining eConsent, ensuring that the patient is properly informed of their rights and how the trial might affect them. This has a likelihood of affecting participant retention.
Thompson detailed how some VCTs are able to get around this problem by putting eConsent into different more interactive forms to allow greater engagement and even test the patient’s understanding of their rights.
He stated that these could come in the form of games, quizzes or video media to help inform those patients in a better way.
The presentation also showed how the majority of VCTs have been occurring in the field of medical devices, with a significant majority of those taking place in Europe or North America and 34% of these centring around wearable technology.
However, this also presents its barrier, introducing a need for internet access that might be out of reach for some of the potential cohort of participants.
Thompson added: “VCT’s are here to stay. Every major pandemic in history has left some kind of major mark on the healthcare system. With polio, we saw the creation of the intensive care unit. Following Covid-19 I think we will see that the clinical trials landscape has been permanently changed and that virtual clinical trials will be here going forward.”