The rule book when it comes to delivering innovative clinical research is now being rewritten on a monthly basis. There is now a far greater expectation for medical mysteries and biological riddles to be solved in record times. Needless to say, UK clinical research is setting the pace
It’s an Olympic year. The only time when most of us will regard a single second, as a preposterously laboured unit of measurement – one which must be further divided in order to determine the difference between gold and less precious metals. And yet, this need for speed increasingly dictates our wider expectations. In life, we all hold a stopwatch – literally and figuratively. We want things faster. Clothes, food, technology, entertainment and yes, medicine.
Clinical research remains the most complex, exciting and multifaceted of undertakings. Developing a treatment and proving its safety and efficacy is a global pursuit, but in 2020 the UK continues to have its finger on the pulse, as a key pioneer and exponent. The challenges inherent in this area are monumental – to redefine what is possible across hundreds of disease areas, to solve the most complicated conundrums of our existence and to ultimately change the outcome of a predetermined result.
There are also the hurdles of clinical trials and regulation to consider. Clinical research, by its very nature, touches all aspects of the human condition, from the minutiae of scientific discovery to the more romantic notion of sustaining life, in spite of the perils which threaten it. These concepts work in tandem as a deeply compelling motivation for enduring and successful clinical research, but within this race against time, there is a runner whose day of reckoning has truly arrived – the patient.
Even amid the political unrest of the past few years, clinical research has had the ability to rise above the situation on the ground – as if existing in the orbit of Brexit, rather than being entirely submissive to it. If anything, since the 2012 Olympics and its successor, four years later in Rio, the bar has been raised higher than ever before.
Divya Chadha Manek, head of Business Development at The National Institute for Health Research (NIHR) Clinical Research Network (CRN), has had one of the best vantage points to witness the clinical research high jump, and is passionate about the sector’s unique strength and resolve: “I have worked for well over a decade in the UK clinical research environment, and I have never seen such determination by multiple stakeholders to support the UK’s position as a global leader in clinical research.”
The government’s Life Sciences Industrial Strategy aims to leverage the UK’s hotbed of clinical research talent, while also maintaining it as an attractive place for life sciences businesses to operate and innovative start-ups to flourish. An ambition which not only includes the established holy trinity of Oxford, Cambridge and London, but all the UK’s major cities.
NIHR CRN is focused on realising the ambitions outlined within the strategy and also recognises the modern necessity for acceleration and accessibility. “The landscape is evolving with new and faster ways to bring treatments to patients,” explains Divya.
“We are committed to putting measures in place to set up studies quickly, while also delivering efficient and ambitious patient recruitment.”
Indeed, Patient Recruitment Centres (PRCs) – led by the NIHR CRN – have demonstrated the forward-thinking brand of innovation which is set to shape the future of clinical trials throughout the NHS. These centres will increase the NHS’s capacity to deliver research, stimulating significant growth and opportunities for both patients and the life sciences industry.
The new facilities have been made possible through a new £7 million government investment into five purpose-designed centres, dedicated to late-phase commercial clinical research. Within the centres expert staff work in accordance with a franchise model for rapid set-up and the recruitment of patients into clinical trials. The latter stages of a product’s journey to approval are notoriously fraught, so such examples of specialised, patient-led innovation will be crucial, particularly as clinical research navigates the post-Brexit ecosystem in the coming years.
In the past, the way we went about our daily lives – jobs, interests, consumerism and relationships were rarely mirrored by our behaviour in healthcare settings. For centuries, we were distant bystanders, counting our shoes in soulless waiting rooms. As we embrace the digital stratosphere, and become authorities on our own health, however, we increasingly replicate our wider consumer experiences within a healthcare context – no longer satisfied to watch from the stands.
The convenience of ordering and tracking online is now repeated when it comes to making an appointment with a doctor or ordering a prescription, and this approach is also transforming the experience of patients on clinical trials, enhancing participation through flexibility, but also making the pathway and, critically, patient input far more convenient.
This notion of making the patient a fully integrated part of the clinical research mechanism, without creating obstacles, is a vital part of NIHR CRN’s brave new era. Divya explains: “The NIHR CRN understands that clinical research needs to be available at people’s fingertips, if we are to realise our ambitions of increasing access to clinical research and boosting the number of patients involved.”
Meanwhile, patients are being integrated into clinical research in many other ways – further removing them from the role of passive participants. ‘Be Part of Research’ is the NIHR’s online service through which anyone can find out about health and social care research taking place across the UK and aims to provide patients with greater choice when taking part in clinical research.
The NIHR CRN also recently launched the ‘Patient Engagement in Clinical Development’ (PECD) service to the life sciences industry, with NIHR CRN acting as ‘matchmaker’, in bringing patients and the life sciences industry together early on. This ensures that trials are designed effectively, while also taking into consideration the patient voice. With that in mind, the NIHR is also supporting over 600 research champions who are volunteering their time to help spread the word about health and social care to patients and the public.
Divya reflects: “Patients are savvy in their expectations of clinical trial delivery. Putting them first and making clinical trials easy to get involved in, while maintaining the required rigour, is the future of delivering patient-centric clinical research. After all, everything we do in clinical research has the end user at the heart of it.”
Innovations in clinical research have accelerated from the pace of someone trying to wade through the crowd at the back of the London Marathon, to the speed of a 100m Olympic sprinter.
These accelerants can be via the treatments themselves, such as advanced therapies, but also through the smarter delivery of clinical research. Complex and innovative designs are an evolving concept and the NIHR CRN is responding to the evolution by supporting the next generation of clinical trials.
For example, NIHR has recently backed a study into Berger’s – a rare form of kidney disease for which there is no disease-modifying drug or treatment available. The study tested the efficacy and safety of a new treatment, where different cohorts of patients were being administered with varying doses. Each stage of the trial informs the next one, so the trial evolves and adapts as it progresses.
Consequently, there is no reason to stop the trial and start a new one, and this is absolutely crucial in saving time and money in the clinical development pathway. This is an area where the different stakeholders in the UK clinical research universe have welcomed modern innovations – from a regulatory perspective, right through to delivery.
Further inroads can be made through big data and accessing it for the purposes of clinical research. Divya says: “As part of the NIHR CRN’s free Study Support Service, we have developed a research targeting tool which lets us compare research activity with the disease profile of each CCG in England. The capability of combining complex and innovative designs and processes, alongside leveraging the power of data in clinical research can make the journey even smoother.”
Progress, however, still requires the same axis of fundamental principles, just as the Olympics will always have running and jumping and throwing (although you can, of course, add skateboarding to that). “Innovation doesn’t have to be about ‘sexy science’,” says Divya. “In the words of the great Thomas Edison, ‘There’s a way to do it better – find it’”.
And Thomas/Divya make a good point. It’s a call to action that still resonates today, as clinical innovation reaches unchartered territories and at unprecedented speeds, often satisfying our basic human desire to move the ‘finish line’ further and further away.
It is perhaps most rewarding, however, to reflect that the process by which a medicine’s potential is realised comes through a number of cooperating elements – a relay in which the patient is passed the baton, not and the end of the the race, but during it.