Bringing clinical trials to the home: a game changer for the sector

COVID-19 has highlighted the vital importance of clinical trials for drug and vaccine development, but it has also forced Singapore's pharmaceutical and healthcare companies to completely 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 Singapore.

ACCELERATED ADOPTION

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 Singapore has already been well documented. Indeed, a recent survey by Mercer found that 78 per cent of respondents from Asian countries said they were ready to use digital healthcare or telehealth technologies.

For clinical trials, the opportunity centres 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 up 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.

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 enrollment process much easier, without patients even having to leave the comfort of their sofas.

A MAJOR PARADIGM SHIFT

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

Even in a city-nation like Singapore, commuting to trial sites can be a burden on patients, including lost days from work, travel costs and time, so 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 staff up from cumbersome administrative tasks so that they can focus more attention on value-add roles, and continuous monitoring will provide a much richer data sets.

Singapore's combination of high device penetration, 5G roll-out and focus on Smart Nation initiatives makes it an ideal testbed for facilitating this shift to the home. However, some issues to its wider adoption remain.

PUTTING THE 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 Singapore.

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 on board. 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.

Transparency is key to building trust, and Singapore'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 won't be a clinical trial that isn't measuring potential biomarkers continuously rather than at discrete points in time, whenever they can. Singapore has the set-up and infrastructure to be a pioneer in this field, provided government and industry work together to put patients first.

• The writer is senior vice-president, Asia-Pacific, for Medidata, a Dassault Systemes company