Putting Virtual on Trial

Words by Kirstie Turner

Virtual clinical trials are being adopted as an answer to the imposed limitations of lockdown measures brought on by the the coronavirus pandemic. The industry is testing these remote methods and finally unlocking the virtual future of clinical trials.

The word ‘crisis’ in Chinese is comprised of two characters: one meaning danger, the other, opportunity. COVID-19 has created tragedy across the world, forcing us to rethink our way of life; but from some of the hardest times come some of the greatest innovations. As the pharmaceutical industry guides the world through these troubled waters, the power of virtual is proving to be a steady oar. Virtual clinical trials have been implemented out of necessity, but once lockdown measures are lifted and life returns to some form of normality, will remote trials sink or swim?

The pandemic has forced us to think differently and adopt virtual solutions: “We can’t keep doing the same thing we’ve always done because patients can’t go to their clinical trial sites, they can’t leave their house. So how do we work around that?” asks Jessica Federer, Former Chief Digital Officer, Bayer, at eyeforpharma Barcelona virtual 2020.

Virtual clinical trials offer a safe alternative to on-site trials, ensuring that drug testing and development is not hindered by the outbreak. Rasmus Hogreffe, Head of Virtual Clinical Trials, LEO Innovation Lab, believes that this is not just a temporary measure: “The COVID-19 outbreak will drastically change the way we run clinical studies in the future.” Virtual trials may well be here to stay.

There are many other reasons to conduct more virtual trials: “We all know that it is getting more and more costly to conduct clinical studies. We need to rethink the way we conduct these so we can generate a profit that can be reinvested into R&D,” explains Hogreffe. Pharma is becoming more driven by technology and clinical trials cannot be left behind in the virtual shift.

Looking to the coming years, there is going to be a mismatch between increased need and decreased resources: “It is predicted that we will be conducting more and more clinical studies over the next couple of years, but we will also have a decreased number of people who can be involved in clinical studies. We can use digital solutions to fill this gap,” adds Hogreffe.

The potential for participation is huge, but significant investment must be made in order to set up trials for success: “We are very fortunate that we made massive investment over the past couple of years in underlying platforms that now allow us to have 4,000 people remotely running clinical trials virtually,” explains Bertrand Bodson, Chief Digital Officer, Novartis.

However, investment in new technologies is not critical for those who want to conduct remote clinical trials. There are many devices that are ready for use: continuous glucose monitors, continuous electrocardiogram monitors, blood pressure monitors, fall detectors, smart pills, and smart phone cameras, as outlined by Hogreffe at eyeforpharma.

And the benefits are boundless: “Decentralised clinical trials are an important option to open-up access and diversify the patient and participant population,” explains Dr Michelle Longmire, CEO and Co-Founder, Medable. Barriers to attendance, such as physical distance or inability to travel, are no longer relevant.

“This will allow much more access to participants who can get involved in clinical studies. I believe we can increase the safety because we are capturing much more data. We can also improve the convenience for participants, and that may lead to a reduced drop-out rate,” adds Hogreffe.

The loss of a real-world location does not mean that the benefits of this physical site are lost in a virtual trial: “A decentralised clinical trial is going to remove the physical site as a requirement, while still leveraging many of the skills and capabilities of the site, but facilitating that through technology to happen remotely,” explains Longmire.

With a higher number of participants, increased data, increased safety, and improved retention rates, virtual clinical trials can reduce the time needed to take a drug to market: “We believe the time to market can be decreased meaning we can save a significant amount of money and bring cheaper, better treatments to patients faster,” Hogreffe adds. As a solution that can improve treatment options for the patients in a shorter time frame, adoption of these trials is a no-brainer.

The evidence is not just theoretical, there are also real-world examples to back it up. Hogreffe goes on to discuss a LEO Innovation pilot study that used virtual clinical trials: “It took us 7 days to enrol 55 patients with atopic dermatitis and when we ended the study and looked back, we had a retention rate of more than 96%, which is kind of amazing.”

The industry has been reluctant to embrace virtual clinical trials in the past, but as we weather the COVID-19 storm together, the question must be posed: if not now, then when? “Digital trial technologies will change the way that we conduct clinical studies in the future,” concludes Hogreffe, adding: “This is a time for innovative thinking and we simply cannot afford to miss this opportunity.”