An exciting, futuristic chapter for clinical trials has opened in which participant engagementwill flourish, expansive data will navigate the maze of disease and digital technology will take pharma and patients to previously unexplored dimensions. John Pinching reports.

As the spectre of digital casts its light across clinical trials, historically invasive and regimented processes are giving way to convenience, engagement and, ultimately, innovative treatments. Those taking part will no longer serve as a restricted, inconvenienced group, but as unconfined, fully participating individuals. Many will go about their daily lives, while simultaneously changing the world – like humanitarian multitaskers in a deleted scene from Blade Runner.

Wearables, implanted microchips and digital medicines are allowing people the freedom to, at once, live and be part of a clinical trial. Individuals are combining on a global basis to produce previously unimaginable levels of information. Remoteness is, hence, being redefined, not as something untouchable or even aloof, but as a byword for positivity and possibility.

Take medicine adherence – not only can you be reminded to take a pill remotely, you can be encouraged by your healthcare professional from a distance to do so. Furthermore, a GP can receive confirmation that a pill has been taken and – pivotally – be in no doubt as to exactly who took it. Try explaining that to someone 25 years ago (at the time of writing this remains a hypothetical challenge).

But it is not just technology that will enhance and demystify the clinical trials space – it is also the upsurge of curiosity, from the general public, in its own health. It is this ‘perfect storm’ which

will make it commonplace for modern clinical trials to leave the confines of medical institutions and become integrated into the colour, definition and breadth of our realities. Monitoring the human condition in its natural habitat will revolutionise the way data is interpreted, but also change the data itself. In a world of technological wizardry, it is somewhat reassuring that this compelling note of realism will resonate throughout the world.

William Hanlon, group president, Clinical Development and Commercialisation Services at Covance, explains how the modern clinical trial environment is already taking shape. “Digital technology is changing the way we carry out clinical development. We can prescreen potential trial participants online, while using proprietary data to pinpoint relevant patients. Digital technology provides continuous, ongoing data collection, as opposed to short episodes at physician offices or hospitals.”

Tom O’Leary, CIO at ICON, believes that the new era will yield pivotal milestones: “Technology which allows the constant monitoring of – and communication with – patients in real time, creates the opportunity to assess the results of drugs and devices at a groundbreaking level of granularity, and over a range of real-world conditions. This is particularly essential in terms of rare diseases where there is little understanding or knowledge.”

As Tom and William point out, the clinical trial of today and tomorrow is cutting out the wasted months and the drudgery, offering something that patients and participants can truly believe in – a dynamic, digital and efficient conduit for hope.

Personality of progress
There are a whole host of reasons why a person volunteers for a clinical trial - wanting to advance medical science, having a chronic condition or getting access to a particular medicine. In the modern ecosystem, however, the melting pot of a one-size-fits-all approach is rejected and even the ambitions of personalised medicine are not enough. The new world is about embracing individuality and appreciating the currency of every participant.

“Showing evidence of how participation in a clinical trial improves the overall outcome for patients is key,” said Tom. “Incorporating the patient perspective at the design stage of a clinical trial empowers them and provides ways to ease the patient burden. Leveraging technologies which allow for the capture of data and information about patients and their condition, as they go about their daily lives, is a prime example."

William believes that gaining trust creates the vital foundation for the relationship between industry and clinical trial participants: “It’s important that we understand what it actually means for a patient to feel valued, engaged and empowered and this begins early in the clinical trial design. To attract patients, we must understand what motivates them in the first place. Ultimately, ongoing communications and clearly defined expectations are critical to the value and engagement proposition.”

Recognising the needs of each patient is all part of the broader clinical trials panorama, allowing greater perspectives, across both physical and mental vistas. Tom said: “Striving to deliver outcomes that restore or improve the quality of life for the patient is key in assessing and measuring the benefit that drugs and devices deliver.

Indeed, it is striking that as the clinical trial template broadens, and participants have the potential to combine and become ‘superorganisms’, the focus still remains on every element, with pharma companies appreciating that the strength of the collective can only be galvanised by the recognition of each moving part – each human being.

“Participants need to understand their role, and only then can they realise their ongoing importance to patients and researchers worldwide,” concludes William.

Next generation game
As we are discovering, global tech companies have played fast and loose with personal data; their relative inexperience when it comes to handling it has led them to the dark arts, like a moth to a flickering smartphone at the three in the morning. In contrast, it is in the DNA of pharma companies to protect the sacrament of patient data – pharma companies, even in the analogue world of yore, were hardwired to use it respectfully. Yes, some hard lessons were learned along the way, but I doubt that there is an industry better prepared to surf the relentless digital waves of confidential material than pharma.

Let’s face it, the relationship between medicine producer and medicine consumer goes back a long way. The sweet spot of trust only arrives in the overlap between regulation and, critically, motivation. For decades the pharmaceutical industry has been the most regulated in the known universe, while the people who work in that industry are largely motivated by changing, extending, improving or saving lives (either that or I am a pretty lousy poker player).

Tom is under no illusions about the potential of digital information from participants: “Sharing appropriate data, gathered from the patient, directly allows that person to comprehend how they are progressing with the management of their condition and how they may compare with others who are managing the same or similar conditions.”

The challenges for industry, however, should not be underestimated, as William explains: “Within the digital landscape, it will be imperative that industry demonstrates that patient data is confidential and safe- guarded. Patients need to understand the measures a company takes to secure data and understand how it will be used. Overall, I think there is a well-established belief and trust that the pharma industry, with regulator oversight, produces effective therapies that benefit patients. Innovation in the sector has brought us advanced treatments for breast cancer, HIV and cardiovascular diseases.”

“Clinical trials are one of the best care options which patients can avail of in the management of their disease or indications. The more that can be done to encourage them to participate the faster new medicines and devices will be available to treat patients,” added Tom.

Indus-trial strength
The new generation of clinical trials will become pharma’s equivalent of the industrial revolution. As the pistons of 21st century humanity fire up, bridges between disparate communities will be built, biological connections will be established, tracks will be laid for life-saving medicines and the direction of travel will be better health for mankind.

The digitalisation of clinical trials will be game-changing. Through the very act of humans existing, incredible swathes of patient data will flow; the minutiae of biological happenings fizzing through interpretive algorithms, solving clinical conundrums in a fraction of a second and deciphering the sort of mind-boggling equations that would make Alan Turing take a cold shower. It could eventually become man and machine’s finest hour.

Some may ask whether this level of examination – this digital dimension – goes against the natural order of things, but most recognise that man’s innately curious nature is what sets him apart. Human beings – aside from the contestants on Love Island – remain the only existential creatures and it is our duty to identify the key to life, or at least strive to turn it, not as a whimsical fantasy, but as a commitment to our children and all those suffering from disease. Our instinct is to preserve; our mindset is to engender hope – we are hardwired to progress.

Isambard Kingdom Brunel had the simple philosophy of wanting to get somewhere, preferably faster. And the engineers of modern clinical trials are no different.

If the full promise of modern clinical trials is realised, the impact will be recorded, not in thousands of lives, but millions. Furthermore, it will unleash the ability of patients to help their communities – both geographical and medical – to access pioneering treatments and, as someone once said, live long and prosper.