Decentralised Trials are the Future.

COVID-19 has changed clinical trials forever.

So far, the virus has over 90 million confirmed cases which have been a huge test for healthcare services globally. With fewer resources available and the safety of patients at risk, CROs and their sponsors have been forced to adapt to ensure that clinical trials can keep running.

This has triggered a boom in decentralised trials.

Decentralised trials allow their patients to participate without visiting a clinical site. Patients are recruited via digital advertisements, contacted through telemedicine and monitored remotely using wearable devices.

Many patients were calling out for more decentralised trials before the global pandemic. This was because of how easy, comfortable and safe they are to participate in. However, in the past, increased adoption of the trials was prevented by resistance from numerous pharmaceutical companies and some CROs that simply did not want to ‘reinvent the wheel’.

Nevertheless, COVID-19 has changed everything. Now many clinical trials have become decentralised to ensure the safety of everyone involved.

With the touch points between the caregiver, provider and the patient reduced in a decentralised trial; the chances of anyone contracting or spreading COVID-19 is minimised. These trials also take-up fewer healthcare resources, allowing them to be redirected to other area of healthcare that are in need.

To find out how decentralised trials are being run throughout the global pandemic and the lasting impact this will have on the clinical trials space, I spoke to two industry leaders:

• Jimmy El Hokayem, PhD - Head of Neurology and Regenerative Medicine at the Center of Excellence for Biorasi
• Charles Herman, MD, MBA - Venture Partner at Digitalis Ventures, a venture capital firm that invests in solutions to complex problems in human and animal health, and Chief Medical Officer at Somatix, which is the creator of a wearable technology that’s supporting decentralised trials called SafeBeing

How Can You Run Successful Trials in a Global Pandemic?

Since the COVID-19 outbreak, Dr El Hokayem has overseen many decentralised trials at Biorasi and achieved a 95% continuance of all clinical trials with no interruption since the COVID-19 outbreak.

Jimmy El Hokayem, PhD 

He credits this success to Biorasi’s early adoption of decentralised trials, which dates back to well before the outbreak of COVID-19 and has provided the US CRO with a strong understanding of the processes involved.

When COVID-19 came around, we’d already perfected this way of working and fully understood the decentralised trial processes. We just had to implement it. This head start really gave us an edge.

Before we go into detail about Biorasi’s success, it’s important to explain that decentralised trials often don’t look alike. You should think of this term as more of a spectrum - starting with minimal use through to a fully virtual trial.

And why’s that? It’s because you have different indications, protocols, complexities, requirements for patients, requirements for sites and so on. Different trials will also have varying end points, primary objectives and secondary objectives. All these factors determine how much can you decentralise a trial.

Biorasi has employed countless strategies to provide successful trials for its sponsors and partners throughout the pandemic. For example, some trials still required sites. To maximise safety, that meant site selection, initiation and close out visits would have to go virtual.

Dr El Hokayem explained that Biorasi overcame this obstacle using smartphones and video recording glasses to conduct a video call. First off, CRAs would be trained to conduct the video call and understand its requirements. Then the research coordinator would wear the glasses and would walk through the site to show the CRA everything. Using that same blast, the clinician in the clinic would be interviewed virtually, as well as the CRA after the visit report was complete.

This was immensely important for us to continue running those trials successfully. However, not all of the trials required this level of virtual support.

For any decentralised trial to be successful, it’s also important to ensure that continuous monitoring of patients is carried out effectively. Due to the safety concerns of COVID-19, the challenge was and still is to do this will as few site staff as possible or completely remotely.

When sites are functional and still seeing patients, reducing patient-staff interaction is crucial. With more technologically advanced sites, Dr El Hokayem explained that they were able to get a data dump from the patients’ electronic medical records (EMR) or electronic health records (EHR) to the electronic data capture (EDC). For other sites, a secure portal would be created for the research coordinator to scan and upload the care records service (CRS) to. Patients could then be monitored remotely.

When the site itself was functional but not able to have contact with the patients, a different strategy would be employed. Wearables and remote patient monitoring devices were worn by patients at home and then the data would be sent to the site remotely.

While this sounds complex, Dr El Hokayem claimed that it was even more challenging when both the site and the patients were in lockdown. Working mainly in the US, Biorasi mainly experienced this in areas such as New York and California. However, this issue has been a prominent issue for CROs throughout Europe.

Biorasi overcame this challenge by going fully virtual, recruiting patients via digital advertisement like social media, contacting them through telemedicine technologies and using remote monitoring devices.

Why Wearables are Crucial

For all these types of decentralised trial, wearables and remote monitoring devices are crucial in providing a holistic picture of a patient's clinical status.

Somatix is a specialist in this and its latest innovation is a device called SafeBeing. This is an AI-powered remote patient monitoring platform for healthcare providers that uses wearable-enabled gesture detection to yield clinical insights and improve patient outcomes.

Like the many other wearables used in decentralised trials, SafeBeing improves patient safety. With COVID-19, it has helped reduce the touch points between caregivers, providers and the patients. However, this is not the only way it improves safety. For example, this device and other wearables are much better at detecting diseases earlier than the traditional monitoring and reporting methods used in non-decentralised trials.

Charles Herman, MD, MBA

Charles told me that this has been especially effective for a use case study with elderly patients that the Somatix had been involved with.

We were able to detect disease earlier and keep patients out of the hospital. This reduced hospital readmission rates into elder care facilities by approximately 17%. We reduced falls because we can predict who might fall and when they're going to fall. We reduced risk of urinary tract infection because we can pick up on things such as trips to the bathroom, urinary frequency, night-time awakening and dehydration.

All these insights aren’t really obtainable purely through interviews or self-reported data.

Charles also spoke about how wearables engage community workers, population health managers, home healthcare workers and so on; by keeping them informed about their patients.

These people play a much more central role in a decentralized clinical trial strategy, compared to a centralised trial. We're empowering them by giving them new tools to monitor patients and giving them new insights into patients to keep them safer.

Some wearables can also provide much more accurate and objective data for trials by monitoring patient compliance. This is achieved with Somatix’s gesture detection technology in SafeBeing.

If we know when someone was supposed to take a pill, by measuring the gesture of the pill taking and correlating that with the self-reported data we can potentially provide new insights into compliance. This is something that the clinical investigator didn't have before.

While this monitoring is important for data, it’s also ensuring that more patients are willing to take part (which is an issue CM Life Science has previously spoken about in this article by Matthew Barrows).

 When you run into issues with compliance in trials, it’s often because you’ve asked the patient to do a lot. So, now a lot of these tools like wearables are almost completely passive in data collection. This allows for stronger data collection and more objective data to work with.

Are Decentralised Trials the Future?

The decentralised model makes clinical trials safer and easier for patients – even outside of a global pandemic - while providing more quality data. COVID-19 has forced the entire space to realise that. While even advocates like Jimmy and Charles recognise that the model is not yet perfect, they and I believe that we have seen enough to know that it is the smarter way of working in the future.

CROs, their sponsors and patients are embracing it – with even the most elderly of patients accepting and becoming comfortable with the technology these trials use.

Do you think decentralised trials are the future? I’d love to know what you think, please email me at Elisabeth.Edmonds@lifesci-cm.com.

You can see more of my content on my consultant page.