Virtual trials take centre stage during COVID-19

We speak to Bruce Hellman, CEO of uMotif, the patient-centric data capture platform specialists, to find out how virtual trials are evolving and why they are more important than ever in the midst of the COVID-19 pandemic.

There are myriad approaches to virtual trials at the moment – what technologies are appearing to be the most useful, and are there any other technologies you can see becoming more prevalent in the near future?

Virtual – also known as decentralised – trials have an important role to play in the current COVID-19 crisis and are set to become the norm in how clinical trials and real-world studies are run. A virtual approach allows people to participate from their homes – ensuring research can continue even when site visits cannot.

In this new paradigm, the technologies appearing to be the most useful are those built with the user in mind. The industry is shunning old slow legacy technologies and moving towards the type of cloud-based, beautifully designed technology that we see more in the consumer world. The most useful technology is without doubt the smartphone. The power these devices bring to virtual trials is clear. Patients are not burdened with learning how to use a provisioned device and can use what’s already in their pocket.

I’m seeing more demand for wearable and sensor technologies that constantly monitor a patient’s vital signs and integrate that data alongside patient reported subjective. Combining objective sensor data with subjective symptoms and patient reported outcome data will provide new insights. It could also remove potential bias in the data and human error. To support this, technological advancements in devices that pair more easily with smartphones such as digital spirometers will become more prevalent.

What are the current pressures in the industry that are making virtual/hybrid trials more appealing?

Patient recruitment, enrolment, and engagement levels are the most common pressures trial managers are tasked with that virtual trials can help solve. If people can register through eConsent and enrol on a study from the comfort of their own home rather than visit a site, the burden is instantly reduced. And if patients never (or rarely) have to set foot inside a dedicated trial site and can submit their data from home, work, or wherever they are it’s much easier to take part. This is particularly the case right now, with so many people unable to leave their homes and health services at capacity. A virtual approach would not be as impacted and still continue.

Beyond the immediate COVID-19 crisis, we’re expecting virtual trials to become more appealing from a sustainability perspective as people consider their carbon footprint. Reducing the number of site visits and therefore journeys will have a positive impact on the environment.

Virtual trials can also help with equality and reducing bias in patient populations. They can help break geographical barriers as well as socioeconomic status barriers. Most trials are run in large academic medical centres, being more accessible to those close enough or able to travel to those sites. By bringing trials into people’s homes we can access much larger patient groups and with targeting we could reduce the potential bias in recruitment.

What are some 'best practice' tips for running a virtual trial arm?

Running virtual trials requires an even higher level of design thinking. It’s critical to ensure patients truly understand the aims of the research, how they are making an impact, and what they need to do. When running a site-based study with in-person training and onboarding we can rely to some extent on the HCP to impart this information. However, in a virtual trial there is a heightened need for clarity of messaging and simplicity of technology.

My top three tips would be:

• Build simple technology and design-out errors. Aim for a single step-by-step flow and minimise the number of options where possible.
• Make the ask very clear. Ensure all participants know what they need to do, when, and for how long.
• Communicate the ‘so what’. Make sure participants understand why their contribution is key and how they are helping make an impact.

Is adherence ever an issue with virtual arms of a trial?

Adherence to any trial can be affected by poor study design, too much burden, and a lack of clarity. These issues can affect virtual trials just as much as site-based trials. However, when those issues are properly addressed in a virtual trial, we’ve seen very high levels of adherence, well above 90%.

In one study in chronic pain, we saw thousands of participants tracking their symptoms every day for six months – an incredibly long period of sustained daily data capture. Participants fed back that their adherence was down to a combination of:

• Simple and easy to use technology
• Receiving regular feedback on study progress, so they understood that their data was making an impact
• Being clear on what research questions they are helping answer

Presumably, you can get huge amounts of data from these kinds of trials – how do you pull the relevant datapoints out of that?

Using digital technology does allow for the capture of large amounts of data, particularly if sensors and wearable devices are deployed. As with any trial, the amount and type of data to be captured needs to be carefully considered and defined. Any technology should be configured to capture only the necessary data and not harvest more than is required.

Clear thinking in the design phase and preparation of a data management plan ensures that key datapoints are known at the start. This allows analysis teams to quickly access the key data to drive new insights. With modern approaches to managing large datasets we’ve found that researchers can easily pull out the key data. In one of our projects the team had over 5.1 million symptom datapoints and millions of rows of sensor data to manage.  Although a huge volume it was simple to manage as the data was clearly structured and labelled from the start.

How else is the COVID-19 pandemic changing approaches to virtual trials?

COVID-19 has created a real sense of urgency to adopt virtual trials, both to help with vital research into a vaccine or cure, as well as helping other research to continue. We are seeing delays to clinical trials due to sites having to close and the social distancing measures currently in place. If some of these trials had a virtual methodology they could potentially be running without disruption.

For COVID-19 trials, virtual approaches can help capture data to help better understand the symptomatology and impacts of the virus.  We’ll soon be supporting a number of studies in this area and hoping to make an impact to bring the crisis to an end sooner.

Do you think the pandemic is likely to cause a permanent shift towards more virtual/hybrid trials?

Absolutely. The fact that coronavirus is so contagious and has caused countries the world over to close business and schools and implement social distancing demonstrates the need for more virtual and hybrid trials. The world will be a changed place post Covid-19 and clinical trials will be too.

Do you foresee a time when virtual trials will be the most common form of study in the industry, or will hybrid studies, or even RCTs, dominate?

Virtual trials are the answer for many types of research, and we need to see adoption increase. In regard to the type of trial to dominate I would say it’s a hybrid approach – meaning some site-based visits and some virtual interactions with the study.

Many trials can adopt virtual elements, but lots of trials are complex and will always require patients to see a healthcare professional for their infusion or check-ups. In the drive for more virtual trials we must never forget the vital role that human interaction plays in the delivery of healthcare and research. Our human touch is key and will be even more important following the current crisis.

The best adoption of technology is where it enhances, supports, and encourages better human-to-human interactions. So, the future of clinical trials will be for virtual technology to be used sensitively and thoughtfully to engage patients in research, to support healthcare professionals and investigators to better deliver trials, and to provide value to the sponsors and CROs managing vital research projects.