Why COVID-19 Has Changed Clinical Trials Forever.

With hospitals at the epicentre of COVID-19 outbreaks around the world, clinical trial participants have become reluctant to attend routine check-ups and monitoring.

COVID-19 has also stretched resources in healthcare, which has reduced the number of workers available for clinical trials.

This has put many clinical trials on hold and forced others to shift to a virtual trial structure.

Decentralised, virtual, home, remote trials – whatever you want to call them (I’m going to go with virtual) – allow patients to enrol and participate without visiting a clinical site. Instead, patients take part in their trials while remaining safely isolated in their own homes, being monitored by various technology.

Patient advocates have long pushed for virtual trials because of their convenience.

With the traditional clinical trial model, travel and time requirements have placed too high a burden on participants. This has made recruitment for trials challenging and excluded many groups including working parents, rural communities and the poor.

Virtual trials address this issue and are therefore receive better responses from patients for recruitment.

A Popular Concept

Before COVID-19, virtual trials were a simmering trend  – which you can read about in my colleague, Matt Barrows’, article “Are Decentralised Trials Healthcare's Gateway to the Future?”. They were gaining in popularity, but nowhere near what we're seeing today.

Virtual trials have long been technically feasible, thanks to wearables, telehealth, online patient diaries, eConsent, video dosing confirmation and patient apps.

In January this year, we saw the first ever virtual trial designed by Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) and PRA to assess the effectiveness of INVOKANA (canagliflozin) in adults with heart failure. More studies followed and the life science sector started to recognise the benefits of virtual trials.

Data was collected, monitored and analysed in real time by the technologies involved. This improved trial efficiency and accuracy. The virtual trials were more cost-effective too, requiring less healthcare staff to take part.

Accelerating the Trend

While these advantages were appreciated, it wasn’t until COVID-19 shone a spotlight on virtual trials that uptake really accelerated.

The effect of COVID-19 has been huge. Thousands of trials, around 80% of non-COVID-19 trials, have been stopped or interrupted. The pandemic has forced companies and sponsors to adapt with social distancing and safety at the front of mind for each trial. So, they have.

Encouraged by regulators’ openness to protocol modifications, Adial Pharmaceuticals announced that they were modifying a pivotal Phase III trial of their alcohol use disorder drug AD04 to include telemedicine-based assessments and behavioural treatment, with fewer, shorter, in-person visits.

While this is an example of studies adapting to COVID-19 and shifting towards virtual trials, it must be appreciated that this is not possible for everyone. For many studies, a full-scale shift to remote monitoring would be too complicated, requiring massive protocol amendments and jeopardizing data integrity as a result.

However, it was a noticeable landmark for virtual trials.

In such a turbulent period, Johnson & Johnson’s two fully virtual trials have remained uninterrupted. This has also been a stand-out advert for these remote trials.

The pharmaceutical giant’s Heartline study, uses the Apple Watch plus a specially designed app to screen patients for atrial fibrillation, irregular heart rhythms that can signal an increased risk of stroke. Meanwhile, their CHIEF-HF trial is a drug intervention study, investigating whether SGLT-2 inhibitor Invokana (canagliflozin) can help improve quality of life among heart failure patients.

The Challenges

However, virtual trials aren’t perfect. They have their own barriers to entry like the need for smartphones and strong internet connections, which can exclude older and lower-income participants.

It’s also important to understand that virtual trial aren’t considered ideal for all types of study. Phase 1 trials, which focus on patient safety, and those that treat acute health problems are thought to need support from trained healthcare staff.

That said, the benefits of virtual trials are there for all to see. They’re more efficient, more cost-effective, accurate and make patient recruitment a whole lot easier.

Now that COVID-19 has driven medical centres to set up much needed technology and forced the FDA to release guidelines for virtual trials during the pandemic, it is hard to imagine clinical research going back to the way it was before.

COVID-19 may have changed clinical trials forever.

Do you agree? I'd love to hear your thoughts on the future of clinical trials. Please give me a message at Elisabeth.Edmonds@lifesci-cm.com.