Picture yourself cruising down a highway, rolling down the window to let in the fresh breeze. The only sound accompanying the rustling wind is the gentle hum of your electric car. You inhale deeply, savouring the crisp, clean air despite being surrounded by traffic. That's because every other vehicle on the road is electric, too. It's a captivating vision, one that was promised to us 15 years ago when electric cars first began emerging from factories. On their own, electric vehicles are an attractive proposition. They’re cleaner, quieter, and cheaper to operate. They're also widely available. And while electric cars are getting more common, we still are far from fully realising this electrified world we once dreamed of. Why is that?

The answer lies in the practicalities. Sure it’s nice to have a cleaner, quieter car, but taking the long way around so you can spend a couple hours at a charging station half way through a road trip is not ideal. So while we can still work towards cleaner transport, progress is slow.

Much like electric vehicles, the digitisation of clinical trials represents lots of opportunity for impact. We’ve seen digital systems make improvements to many aspects of clinical research, but the next generation of digital clinical trials hasn’t materialised. The full potential is still held back by real-world hurdles. Unlike electric cars, we’re in a position to address those challenges right now.

Clinical healthcare trials 

For many, going digital may be a default response, but questioning the value of the current digital landscape of clinical software is certainly valid. Imagine the perspective of a research professional who has been conducting clinical trials using traditional paper-based methods for many years. They've grown accustomed to the process and, while not inherently opposed to change, they are naturally risk-averse.

When people start to promote "digitisation" as a solution, these professionals are often hesitant, and rightfully so. Digital solutions introduced so far have generated more work, often requiring the duplication of data and adding set-up headaches, all the while not providing much more value. This could leave a clinical researcher wondering if the potential benefits of digitising a single aspect of a trial are truly worth the risk of moving away from a proven method.

There’s a good chance that they’re right. It might not be worth it. Digitisation in clinical trials has two key value propositions, and moving only one piece of a trial to a digital system fails to cash in on either.

The first value proposition of digital data lies in its ease of replication and transfer. This allows data (including protocol information, not just clinical data) to be easily moved from system to system, reducing human error, ensuring valid data collection and enabling near instantaneous analysis. Complete digitisation paves the way for digital data flow, a concept poised to revolutionise the field and usher in the next generation of clinical trials.

The true value lies in the transfer of digital data, rather than its mere existence. Without a predefined approach for communication, digitising only one or two separate systems within a trial creates overhead, not value. 

Fortunately, this issue is not insurmountable. At Lindus Health we understand the potential of comprehensive digitisation. By conducting end-to-end trials with an in-house clinical operations team and software development team, Lindus Health is uniquely positioned to reap the benefits of digitisation that exist between systems.

Healthcare data & digitisation

Our approach has already shown transformative results, as evidenced by our ability to export data directly to SDTM format from our Electronic Data Capture (EDC) system. Moreover, at the CDISC EU 2023 Interchange, we showcased the integration of the CDISC Open Rules Engine into our system, ensuring that data is submission-ready at the point of collection. Although this advancement may appear leaps ahead of existing solutions, it is a simple and natural progression from a fully end-to-end digitised system.

The second value proposition, although not yet fully realised, is equally thrilling: the application of artificial intelligence. At Lindus Health, we are already seeing the value AI can provide in clinical trials, from predicting which participants may require adherence reminders to analysing protocol documents for suggested improvements or detecting inconsistencies. As more and more of the trial ecosystem is digitised, the opportunities are endless.

Much like the electric car, trial digitisation holds immense potential, but achieving that potential requires overcoming some practical challenges. By focusing on end-to-end digitisation and leveraging the benefits of digital data flow and artificial intelligence, organisations like Lindus Health are leading the way in shaping the next generation of clinical trials and transforming the landscape.

The future of clinical trials depends on harnessing the power of digitisation to its fullest extent, and that future is already taking shape at Lindus Health.

Byline written by Amiel Kollek, Senior Software Engineer at Lindus Health