Steve Sanghera, chief executive and co-founder of Inventus, says that clinical trials can only be as strong as the devices and technology holding them together.
Clinical trials have evolved: patients are no longer expected to do everything from a single site, on a fixed schedule, under tightly controlled conditions. Data is captured remotely, and devices move across borders.
Trial activity is more often than not decentralised and now takes place in homes, hospitals, clinics and community settings. That widens access and produces evidence of greater quality, closer to real life.
However, it has also exposed a shortcoming the industry has been slow to reckon with: the quality of a trial now depends as much on its infrastructure as it does on its science.
When a study depends on connected devices, software and remote data capture, the trial is only as reliable as the infrastructure.
A device configured incorrectly, or a software update pushed at the wrong time, can cause disruption for a trial, as can poor in-country connectivity or settings drifting away from protocol. None of these problems sounds dramatic, but they interrupt data flow, undermine consistency and create friction for patients. The end result is that a trial fails to start and finish as it should. If the average patient generates an estimated £28,808 in economic value through clinical trials, the wider implications for trials being interrupted are huge.
Decentralised and global trials increase pressure
Connectivity and device oversight are not technical back-office issues; they sit at the heart of successful trial delivery.
We see this first-hand, running trials in more than 80 countries and have deployed 550,000 devices for use to date, which have been used in more than 1,000 clinical trials. Devices which provide reliability and a positive patient experience are integral to the clinical study and its design.
Seamless and uninterrupted connections are vital components for a positive patient experience to ensure they remain with a trial from start to finish.
Once a trial extends beyond a single site, there is no excuse for patchy connectivity. Patients may be using devices in different languages, on different networks with different settings and will often be in different locations. Sponsors need consistency. Regulators expect compliance. Patients expect something simple and dependable. That pressure is only increasing.
Current data projects that the decentralised clinical trials market will grow from $9.87 billion last year and reach $15.45 billion by 2032. As these models scale, dependable connectivity and device control become of vital importance, not less.
A clinical trial device should not be a repurposed consumer handset, yet sadly, this is still too often the case.
I understand only too well how important a clinical trial is and have first-hand experience working with sponsors. The integrity of a clinical trial demands purpose-built technology, specifically designed to meet the needs of patients, sites and sponsors.
We see the difference this makes in practice. That means approved applications deployed correctly. Settings locked down where necessary. Updates controlled, not left to chance. If that discipline slips, the effects show up quickly. Data can be delayed or captured in the wrong way, and patients can lose trust. This ultimately can lead to patients dropping off trials, all of which creates more delays, increasing costs and a hindrance to approvals.
Building the backbone of reliable trials
Infrastructure matters, not because the technology itself should be centre stage, but because it shapes whether a study works in the real world.
Reliable connectivity matters just as much. In decentralised trials, data does not reach the study team by accident. From our work deploying connected trial devices, we have seen how much depends on infrastructure that can keep devices connected consistently across networks, settings and geographies.
Healthcare leaders talk about faster access, stronger evidence and better patient participation. None of that happens by magic. It depends on systems that work under pressure and at scale.
People who take part in trials give time, attention and often sensitive health data. If the device in their hand fails or makes simple tasks harder than they should be, confidence drains away and retention suffers.
The industry has outgrown piecemeal fixes. Trials are too complex and costly for hardware, software, connectivity and logistics to be treated as separate concerns. Those things need to work as one.
As trials become more digital and distributed, delivery depends on whether devices stay connected, controlled and secure throughout the life of the study.
That may not be the most glamorous part of clinical research. But it is now one of the clearest dividing lines between trials that run smoothly and trials that spend their valuable time recovering from preventable disruption.
If we want more resilient, more accessible and more dependable clinical trials, we need to treat connectivity and device control as core infrastructure.
