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Amid the chaos of Brexit, pioneering clinical research continues defiantly, plotting its way through the complexity of disease and providing patients with the currencies of hope, transformation and reinvention.

Barely four years ago, you rarely heard the rather irritating expression, ‘is that even a thing?’ By the same token, the term ‘no- deal Brexit’ was not a thing and nor was Prime Minister Johnson. Evidently, ‘thing’ and, indeed, ‘things’ change.

They certainly do in the avenues and alleyways of clinical research, and yet, its constant need for metamorphosis is an oddly reassuring certainty. Indeed, in recent years, as the human race and its environment aligns with digital developments and technological wizardry, a profound set of challenges for clinical research have duly materialised. This has reinforced the need for constantly evolving skills, intrepid exploration and an insatiable appetite for biological code-breaking. In other words, all the things that have consistently defined the uniquely well-oiled travelator of UK clinical research.

The sum of clinical research’s parts are complicated and numerous, but the National Institute for Health Research, in particular, has been pivotal to the success of the past decade – keeping the UK at the forefront of clinical research, while encouraging cross- sector alliances. Clare Grace, VP Site and Patient Access at Syneos Health, explains: “The focus that the NIHR has placed on academic research and, critically, industry sponsored studies, has been highly significant. Clear delineation of process and resource for conducting research within the NHS has enabled faster start up timelines and a much higher volume of research.”

This positive stirring of the healthcare status quo has resulted in more patients than ever embracing research as a legitimate care option in their treatment pathway and, consequently, the UK continues to be considered one of the best countries in the world to carry out research – adding another chapter to a long history of clinical research mastery stretching back several centuries.

Carpe diem

By placing the trials and tribulations of clinical research into a historical context we can appreciate many of its enduring truths. Throughout history clinical researchers have always strive to take the flawed building blocks of life and attempt to redesign them – releasing the potential of interventionism, and resisting the bland inevitability of disease or premature death. It’s a poetic paradigm that has stood the test of time.

In that regard, today’s clinical research visionaries are undoubtedly standing on the shoulders of giants, whether it be Scottish scurvy slayer, James Lind or tuberculosis terminator, Sir Austin Bradford Hill or – more recently – the maverick clinical researchers of the early 1980s, at St Mary’s Hospital in London, who trialled breakthrough HIV/AIDS treatments.

The UK probably has more ghosts of clinical excellence stalking hospital corridors and laboratories than any other nation on the planet. Move your ear closely to their portraits and they seem to whisper, ‘seize the day’. They are the drivers of change and the steerers of ambition – the foundation upon which contemporary clinical research is fuelled.

Emulating figures of the past is an omnipresent challenge in itself, but taking on disease remains the conundrum of a lifetime (quite literally), irrespective of era. It is the mystery that binds us, whether it be as a patient, researcher, physician or someone with a passing interest in humanity.

Clinical trials are so often the crystallisation of a therapy’s impact – the final analysis, after which a product could be released as a force for good, redesigning lives for the better. The key to an ultimately successful journey to market, however, has always been determined by collaborative partnerships with patients.

The ability to mobilise people afflicted by disease is always at the mercy of a complex set of determining circumstances; this could involve the location, whether a disease is common or rare, the willingness of patients to form a cohort and the likelihood of a product’s success. Just as clinical research has evolved, so have patients and the gap between pharma and the people that use its products has narrowed exponentially.

Street parties
The seed of modern patient culture germinated in the 1990s, during the emergence of the internet, and has blossomed in the past few years, culminating in the rebooted patient – individuals with greater control over their own health, an expansive knowledge of their condition, constantly updating real-time data from wearable tech and, critically, a desire to engage with industry. Patient 2.0 is now the guest of honour at its own healthcare party and just as likely to dictate the dance moves.

“Patient interest and involvement in research is fundamental, and the modern patient is definitely far more curious and passionate than ever before,” says Clare. “Patients are better informed about treatment options and potential treatment solutions. This drives them to seek out potential new therapies, especially when conventional medicines are failing them.”

In addition, there has been a shift in priorities from Patient 2.0, indicating that well-being in the real world does not always translate to a traditional scientific barometer; that the patient experience is far more nuanced. Patients are now reporting about pharmaceuticals, not in the lab, but at street level. Clare reflects: “Patients are a lot more demanding of the pharma industry – they want to be involved in determining clinically relevant endpoints that actually provide the best improvement in standard of living, as opposed to the most scientifically valid endpoint.”

It is this shuffle of the clinical cards that most clearly demonstrates that the healthcare habitat is changing irreversibly and, as a consequence, an exciting parity between the probed and the probers is emerging.

Access all areas
A consistent industry ethos about bringing established, newly approved or pipeline medicines to patients has also helped to accelerate processes in the notoriously complicated route to market. Since 2017, Syneos Health has sponsored all NIHR research sites in the UK (over 4,000 of them) to receive a free Society of Clinical Research Sites scholarship. This enables sites access to the experience, mentoring, education and support of a global organisation with an excellent track record of engendering cohesiveness.

By subscribing to a clear set of principles around delivery and access to products there has been a distinct change of mindset around ‘what is possible’ when going through the trial phases and reaching people on the ground. Syneos Health was a key part of the team responsible for the development of an Ebola vaccine, and it saw how joint working yielded a new brand of collaborative determination and, crucially, it witnessed the taming of an epidemic through a rapid response. “Our closer relationship with sites enabled us to work around the clock to successfully deliver research. This was at a time when speed was absolutely critical and, without the incredible relationship we had with those sites, we would never have been able to exceed the timelines for that project,” says Clare.

One of the biggest hurdles to maintaining that level of fluidity is still the quest for patients to participate in treatment development. Navigating the viper’s nest of protocol has never been more complex, while patient populations are increasingly segmented. “This means it is much harder to find the right patient in the first place, as only a small subset of patients with the disease will be eligible for the protocol,” Clare observes. “When those elusive patients are found, it is often difficult for them to participate in research, as the protocols are highly complicated, resulting in an excessive time commitment and a high level of clinical burden.”

Crossing the line
Perhaps the most pressing challenge for pharma in the post-clinical trial landscape is educating, not just patients, but wider society. While many of us become immersed in the Rugby Union World Cup, another story has unfolded involving former Wales captain, Gareth Thomas. His announcement that he is HIV positive (triggered by a particularly unpleasant piece of ‘journalism’) has been compounded by having to explain to family and friends that he isn’t dying.

This seems to be a recurring clinical ‘blind spot’ across many disease areas and a damning indictment of the legislation which consistently hinders industry’s ability to communicate its messages on a mainstream stage. While patients become empowered very quickly once they actually have a disease or are approaching a diagnosis, wider society is blithely unaware of astonishing milestones.

In the case of HIV, the main frame of reference for people seems to be the death of Freddie Mercury, nearly three decades ago. Single pill therapies, an undetectable status, the inability to pass on infection and instant testing have passed many people by. Achieving a normal lifespan is now a reality for people living with HIV, but it has taken an ex-rugby player’s ordeal to enlighten people. His determination to educate is inspiring, but it also casts a light on the missing link between life-transforming therapies and their occupancy in the public’s imagination. Clinical research connected to cancer, dementia, diabetes, heart disease and a host of other diseases should be common knowledge in 2019.

By John Pinching

Source: Pharma Times