It's Time For Smarter Clinical Trials

Covid-19 has accelerated digital transformation in healthcare. Clinical trials are no different.

The global pandemic has put clinical trials in the spotlight.

The news of potential vaccines and their respective trials have been on the front page of every newspaper. It’s meant terms like ‘control groups’ and ‘efficacy estimates’ are suddenly part of the global conversation about how we might emerge from the worst of the pandemic.

But beyond the fight against the virus itself, COVID-19 restrictions have significantly changed how patients approach healthcare generally. In turn, healthcare providers are exploring new approaches to business-as-usual to catch up with these behavioural shifts.

The drive to build back better is high on the agenda of leaders in the healthcare space.

Those who lead clinical trials - one of the most important, yet inefficient and costly parts of the healthcare value chain - are no different. The pandemic, and the accelerated maturation of healthcare technologies around them present a huge opportunity to reboot how we test and refine new treatments.

It’s time for smarter clinical trials.

The cost of (most) clinical trials today

Traditional clinical trials are responsible for two-thirds of the average cost of bringing a new treatment to market. Costs can be as high as $2.6billion for a single intervention, with 90% of development ending in failure.

Digging into the practicalities of most trials quickly surfaces why they are so costly.

Apart from recruiting participants from different sites and monitoring them closely, researchers have to consider factors such as trial design, protocol design, data collection, site selection and trial execution, tasks that can make clinical trials extremely expensive.

But the costs aren’t just those reported on healthcare company balance sheets.

Travel and time requirements, together with the compliance and treatment monitoring complexity place a high burden on participants. This makes recruitment for trials challenging, and often excludes many groups from participating. Those burdens also contribute to high dropout rates, which are a major cause of trial delays and added expense.

How technology can deliver smarter clinical trials

The nature of the pandemic has accelerated exploration of a different way to conduct trials. A decentralised approach, enabled by technology.

Telemedicine consultations mean participants and practitioners can connect and discuss treatment protocols at a distance. Participants can take delivery of studied treatments directly to their homes, rather than collecting them from a healthcare practise. New sensors, wearables and connected medical devices can enable remote monitoring.

These new methods deliver efficiency. But they also radically increase the potential number of data sources that can be monitored and tracked, with gains in fidelity and accuracy possible too.

When executed effectively, this should ensure better accrual of data and monitoring, while reducing risks to patients and research staff, and decreasing associated administrative burdens.

This new approach could be a game changer for medical science.

How we’re making it happen

Bringing together all the technical elements of decentralised and streamlined trials, such as remote monitoring, real world data integration and management can seem like a challenge.

But this isn’t a cold start. There is a world of tools, technologies and approaches that can be leveraged from within healthcare, and beyond it to deliver value quickly.

Some of the key building blocks include:

• Wireless monitoring: Small, wireless, self-powered, passive sensors can be placed in specific parts of the human body to increase the quality of the data captured in a way that is comfortable for the user “wearing” them. Temporary digital tattoos, for example, are akin to a new generation of skin patches, with capabilities including ECG measurement, fall detection, and even drug release.
• Together with CareUK we developed WellWatch to improve remote monitoring. WellWatch monitors an individual’s activity and heart rate for any warning signs, connecting the user to the UK’s 111 service and their emergency contacts when necessary.

• Data ownership and portability: Personalised health reports, data visualisations, and portable raw data provided at the conclusion of a trial will provide participants the opportunity to carry forward their experience and power greater ownership over their health and care.
• K+C worked with a global pharmaceutical company to continuously monitor patient symptoms and take actions to improve outcomes in clinical trials and a real-world setting. This will ultimately ensure better treatment and to reimagine their digital health ecosystem to improve patient care.

• Artificial intelligence and machine learning will direct doctors and patients to existing, appropriate trials based on their data. As these technologies mature, it will be able to determine the eligibility of patients for a trial in the context of the various clinical trials’ requirements and the individual health status of each patient. For such a system to apply across all known clinical trials, all administrative data must be collected and represented in a consistent, standardised, unified form.
• We partnered with a global biopharmaceutical company to enhance patient care coordination via an innovative digital therapeutic platform. Leveraging expertise in AI deployment, the app element was designed to anticipate users’ key priorities at each phase of the health experience, deliver relevant content and drive ongoing engagement.

Now it’s time to get started

COVID-19 has been traumatic and disruptive, but has also catalysed positive change. Rebuilding how we conduct medical trials is just one area that should be revolutionised as we emerge from the crisis.

And for those at healthcare organisations who are keen to get cracking, but concerned by the complexity, it doesn’t need to mean a total overhaul with years of work before any improvements actually start delivering value.

Our service design-led, hypothesis driven approach means we can rapidly unpack existing processes and prioritise the best place to get started and make a difference for ongoing or upcoming trials.

Get in touch with us to discuss how we might partner to make smarter clinical trials a reality in the year ahead.