The COVID-19 pandemic is forcing the clinical trial industry to change the design of ongoing or upcoming clinical trials. Here’s what you need to know to become a virtual clinical trial expert.
Ida Kløvgaard, Virtual Clinical Trial Manager, LEO Innovation Lab
2020 has become the year where people’s lives around the globe have been turned upside down. Many of us are now confined to our homes, and the need for social distancing calls for new ways of being and working. The clinical trial industry is no exception. As a result, regulatory authorities have released several guidelines to assist both sponsors and patients, recommending telemedicine and virtual trial tools as viable solutions to current operational problems.
At this time last year, I was writing my thesis investigating the adoption of virtual clinical trials in the pharmaceutical industry. Just two weeks ago, I was finalizing a blog post discussing how the lack of agreement in the terminology of virtual clinical trials might prevent efficient market adoption. A lot has changed since! We have experienced an explosive maturity rate for virtual trials, and I can only assume that some are feeling as though they are making decisions while treading water. For us at LEO Innovation Lab, virtual clinical trials are the norm already, but this is most likely not the case for most companies. So, what exactly are virtual clinical trials?
Different names for the same thing
There’s no shortage of labels or terms being utilized to define this concept of the virtual clinical trial. From virtual, to remote, to direct-to-patient, to decentralized, to software-enabled, to site-less, to mobile-enabled, to modern, to flexible, to digital-enabled, to 21st-century clinical trials… the list goes on. However, the four primary terms with a general level of consensus across the industry are as follows: virtual, remote, direct-to-patient, and decentralized clinical trials. For simplicity’s sake, I will refer to these trials under the most commonly used term, virtual clinical trials.
What is a virtual clinical trial?
Before we venture further into what constitutes a virtual clinical trial, it’s worth a mention as to why the industry has been shifting to this increasingly digitized model. A virtual trial enables a shift of focus from the trial being location-depended to patient-centered, allowing for a more convenient trial experience for the participant, while at the same time, enabling enhanced data collection, increased patient diversity, and time savings from a trial duration perspective.
In summary, a virtual clinical trial takes full advantage of the many digital tools available to us, and the accompanying real-world data, and is characterized by having no physical visits necessary at a trial site. With inspiration from the digital health measurement platform ElektraLabs, we distinguish between three study designs: traditional, hybrid, or virtual — based on where and how data is collected, respectively. That is, the physical location of the trial site and the method used. The figure below showcases what makes a trial virtual.
Enable the participant’s own smartphone as a way save your clinical trial
The majority of clinical trials conducted today would be defined as traditional trials. Due to the current COVID-19 pandemic, a large number of trials originally designed for a traditional setting are being forced to adapt to a hybridized trial design, e.g. by enabling virtual visits or remote data collection, as illustrated with the red arrow on the figure below. One of our biggest learnings from working with virtual clinical trials on a daily basis is that a hybrid or virtual trial design should be incorporated in the trial protocol from the beginning. Hence, a sudden deployment of virtual tools into a traditional trial can create hurdles that could have been avoided with early planning. However, early planning is obviously not an option for an already ongoing trial, currently being disrupted as a consequence of COVID-19. For ongoing trials, the easiest virtual trial tool to integrate would be a device that the majority of participants already have in their hands (and are likely using even more during these home quarantine restrictions): their smartphone.
The COVID-19 pushes virtual clinical trials into mainstream
No doubt, we are going through a major change in the way the industry looks at virtual clinical trials, switching quickly from “nice-to-have” to “need-to-have”. Virtual clinical trial vendors are currently enjoying some long-anticipated tailwind in the shape of a high market pull as a consequence of new top-down level regulatory guidelines and the COVID-19 pandemic as a forcing event. However, we might still have one small bump on the road to pass before “our norm” becomes “the norm”. This is to be expected due to the frustrations that can appear from the adopters modifying virtual tools as a band-aid solution for already ongoing traditional trials. Nonetheless, it is certain that the market adoption curve for virtual clinical trials has been shortened by up to several years, and my hope is that the industry will continue to take advantage of digital technologies in clinical trials to create more patient-centered trials with better and real-world data capture.
Thanks to my awesome colleagues Rasmus Hogreffe, Andrew Thomas, Mathilde Gilling, and Josephine Wiesener for contributing!