Remote clinical trials: here to stay?

COVID-19 has shed a spotlight on the role of clinical trials in drug and vaccine development, and has also forced Australia’s pharmaceutical and healthcare companies to redesign how these trials are run.

In an era of lockdowns and restricted movement where it may not be desirable for many participants to get to physical sites, the clinical trial industry has had to follow in the footsteps of other healthcare services in the past 18 months, in moving from clinics to the couch so that important research can continue remotely.

This promises many benefits, not least the possibility of shortening timelines for important drug and vaccine development. However, issues of interoperability and data privacy will need to be urgently addressed for it to achieve its full potential in Australia. In fact, interoperability and quality assured technology has been flagged as an area requiring attention for effective and sustainable adoption of virtual health by The Australian Healthcare & Hospitals Association¹.

Moving clinical trials into a home setting is the next frontier, following on from the shift of other healthcare services out of hospital and clinical settings since the start of the pandemic.

From online consultations with doctors to remote monitoring of patients’ vital signs, COVID-19’s acceleration of telehealth in Australia has already been well documented. Deloitte predicts Australia will exceed the global average for telehealth adoption with more than 10%² of Australians regularly using telehealth services in 2021.

The development of eConsent systems and patient portals — whereby patients can access all information relating to the trial in one place and consent via an eSignature — also makes the enrolment process much easier, without patients even having to leave the comfort of their sofas.

For clinical trials, the additional opportunities centre around using apps, sensors and wearables in the home to track important health indicators — like respiratory rate, sleeping patterns, blood pressure and heart rate — that were previously measured at specific points in time during onsite visits and check-ins.

For the first time, this opens the possibility of continuous patient monitoring through passive devices working in the background to collect data 24/7, rather than just gathering data at specific points in the year when patients have physical appointments.

A paradigm shift

For an industry that has relied on paper-based documentation and patients being monitored at fixed sites for decades, this is a breakthrough with huge potential benefits.

Especially in Australia with patients based remotely, commuting to trial sites can be a burden, including lost days from work, travel costs and time. Removing the barriers to taking part is a major boon for an industry that regularly cites patient recruitment and retention as its biggest obstacle.

Collecting and analysing patient data in real time also allows for early detection of both trends and issues, so that important adjustments can be made while trials are ongoing.

As in other industries, digitisation of clinical trials also promises to free up staff from cumbersome administrative tasks so that they can focus more attention on value-add roles, and continuous monitoring will provide much richer data sets.

Australia’s combination of high device penetration, 5G rollout and Smart Cities Plan makes it an ideal testbed for facilitating this shift to the home. However, some issues to its wider adoption remain.

Patient first

Patient willingness to take part in trials from home will be the main deciding factor in how quickly and successfully this new model can be adopted in Australia.

Allowing patients to use their own smartphones and devices, rather than having to incorporate separate, provisioned devices into their daily routine, is one way to get patients onboard. This will require a complete rethink of the way trials are designed. However, the even bigger issue to be addressed is reassuring patients of their privacy. Privacy is a major concern for 70%³ of Australians, and almost 9 in 10 want more choice and control over their personal information. The way we address this concern is through transparency.

Transparency is key to building trust, and Australia’s government and industry will need to work together in prioritising patient safety. This needs to be built into every stage of trial design and the industry needs to consider not only the minimum privacy protection requirements by law, but to benchmark against the most stringent standards in the market.

Interoperability is the other major challenge. For remote clinical trials to be effective, all of the different devices and systems in the patients’ homes and the lab need to connect seamlessly. This includes the patients’ own smartphones and devices.

While COVID-19 was the trigger, it’s unlikely that the industry will ever go back to its old operating model. Ten years from now, there probably won’t be a clinical trial that isn’t measuring potential biomarkers continuously rather than at discrete points in time, whenever they can. Australia has the set-up and infrastructure to be a pioneer in this field, provided government and industry work together to put patients first.

References:

^{[1] The effective and sustainable adoption of virtual health care — https://ahha.asn.au/sites/default/files/docs/policy-issue/ahha_blueprint_supplement_-_adoption_of_virtual_health_care_-_july_2020_0.pdf}

^{[2] Telehealth to boom, Australia leads the way in commercialising women’s sports, 5G health risk perception to wane — https://www2.deloitte.com/au/en/pages/media-releases/articles/telehealth-boom-australia-leads-way-commercialising-womens-sports-5g-health-risk-perception-wane-160321.html}

^{[3] 2020 Australian Community Attitudes to Privacy Survey — https://www.oaic.gov.au/engage-with-us/research/australian-community-attitudes-to-privacy-survey-2020-landing-page/2020-australian-community-attitudes-to-privacy-survey/}

Image credit: ©stock.adobe.com/au/ Gorodenkoff