With ‘Brexit Day’ looming, the UK is in need of quick and effective solutions to remain an attractive location for clinical trials. Currently, it is responsible for 3% of the global drugs market. This will be put at risk by exiting the EU, which is likely to see the UK no longer part of EU clinical trial regulations. However, this depends on the final shape of any Brexit deal agreed. One promising solution is the creation of ‘high-throughput centres,’ which could help to cut regulatory approval times and speed up the delivery of trials nationwide.
This was put forward in a white paper by clinical trials accrediting company IAOCR and Jonathan Sheffield, chief executive of the UK Government-funded NIHR Clinical Research Network. Sheffield is a trained doctor, and worked as a histopathologist at Yeovil District Hospital before becoming a medical director. In 2009, he was awarded an OBE for services to the NHS and, in 2011, he was elected an honorary fellow of the Royal College of Physicians’ Faculty of Pharmaceutical Medicine for his contribution in the area of clinical research delivery. As a passionate advocate for clinical research, Sheffield’s ambition is for participation in a study to be a standard treatment option for all patients within the NHS.
The proposal of high-throughput centres has come in response to the Life Sciences Industrial Strategy (LSIS) published in August 2017, which pledged to increase the number of clinical trials conducted in the UK over the next five years by 50%. Sheffield is confident this target can be achieved. This is particularly timely, not only in light of Brexit, but also due to recent clinical trial participation trends in the UK.
” What we’ve seen over the last seven to eight years is a massive increase in the amount of trials and patients that we are recruiting for them,” says Sheffield. ”The purpose behind these centres is to give increased capacity to the NHS to deliver these trials and make sure they are protected from clinical pressures.”
Stepping up to the plate
Sheffield is acutely aware of the existing challenges of conducting trials within clinical settings for patients and staff.
“We often have to run trials in busy clinical environments and that puts pressure on the time that the patient has while they are involved in the trial, but it also puts pressure on staff,” he explains.
However, he remains confident that these centres can meet the needs of clinical trials, without adding to the high burden already on NHS staff.
Sheffield is keen to ensure the smooth running of trials for patients as well as staff and has no doubt that highthroughput centres can achieve this aim.
“We believe that these centres will create the right ambience and facilities to make the conduct of a trial efficient and effective, while also giving an excellent experience for patients,” he says.
His enthusiasm for the UK as a valuable location for conducting trials is clear.
“The UK is one of the best places, if not the best place, to conduct clinical trials,” he says. “We have a diverse population who are engaged in research and want to be involved.”
In light of these benefits, he is confident that the UK can not only maintain its current high rate of trial delivery but even increase this over the next few years.
“We’re 3% of the global drugs market, but we believe that we can deliver 5% of the global market’s trials,” he says.
The increase in trials not only stands to benefit industry but also the NHS as a whole.
“We talk a lot about continuous quality improvement in healthcare but the ability to dramatically transform people’s lives comes from research,” Sheffield says. “That’s an integral part of the NHS.”
Although passionate about the potential of high-throughput centres to benefit patients across the UK, Sheffield remains mindful of the needs of the global clinical trials market.
“The biggest problem for the international clinical research industry is getting these studies done quickly, efficiently and effectively,” he says.
Barriers to this process can include regulation, contracting and set-up. However, Sheffield has no doubt that these centres can overcome these challenges.
“What these centres will offer will be rapid regulatory approval and implementation,” he says.” This will allow us to have a very slick, lean process.”
Sheffield knows that time is money for the industry but his confidence about the capabilities of these centres cannot be assuaged.
“Every day is a day off the patent licence for that drug but also a day of lost revenue if the drug’s not licensed,” he says. “We believe that we can help the global life sciences industry to deliver their studies quickly.”
Despite his optimism, Sheffield knows that these centres must prove themselves before widespread roll out, and plans have already been put in place. A site is in development and due to go online in January. This will be followed by a pilot of approximately three to four additional sites to ensure they are able to deliver the capacity that industry requires.
The barriers surrounding implementation are also top of mind for Sheffield. One of these includes the challenge of getting time-strapped NHS organisations to come on board. However, Sheffield is confident that NHS organisations will soon be keen to become involved.
“It should be seen as a badge of honour that you get one of these centres for delivery,” he says.
Although enthusiastic about the potential of high-throughput centres, Sheffield is aware of the need for high standards to ensure efficient trial delivery. He plans to create a competition where the organisations explain why they would be the most suitable location.
“I think competition is always a healthy way to encourage the best,” he says.
Running like clockwork
Once the centres are up and running, it is of course important to maintain a high quality of trial delivery. Sheffield is clear on what is needed to achieve this.
“We need a consistency in the way that we operate,” he says.” It has be recognisable to industry that the processes are the same across those institutions.”
This isn’t just an aspiration; Sheffield has spent considerable time and thought on how to achieve uniformity. He envisions something similar to a franchise model, where the processes remain the same in each centre to avoid variability in standards across sites.
Acutely aware of the need for speed, Sheffield knows that this consistency cannot come with delays.
”It will be really clear that there’s rapid rollout from one centre to the other centres that you require to recruit patients to,” he explains.
This will involve a standard sign-off so that if a trial has already received approval at one site, this will be sufficient for all other locations involved.
To achieve high standards across all trial sites, Sheffield is also keen to take advantage of technological capabilities. He plans to have IT systems in place that provide visibility of what is happening in each location involved in a trial.
“We want to track the performance of these centres in real time to make sure that they’re delivering what they said they would do,” he says.
A bright future
In addition to maintaining quality of trial delivery, Sheffield wants high-throughput centres to be forward-thinking in terms of study design, which will include testing new research methodologies. Involving patients is a key part of this strategy.
“At the moment we tend to treat patients as being the subjects of research but we want them to co-produce research with us,” he explains.
Being patient-centric is also imperative to ensure that there is a steady stream of willing participants for trials. This is especially important in trials drawing from a small patient population.
“If we’re only recruiting one patient per five million of the population for a rare disease, we can’t expect them to travel vast distances,” he explains.
Sheffield has high hopes of being able to target all types of patients across the UK effectively.
“These centres would allow us to deliver multiple studies at one site and that can be mirrored in multiple sites around the country so there is a constant ease of access for patients,” he says.” That for me would be the perfect vision for the future.”
High levels of patient involvement not only benefits the trials themselves but also the level of care offered by the centres conducting the studies. This spans much further than the immediate participants in the study.
“It isn’t just an effect on the patients involved; even those who aren’t in a clinical trial have better outcomes than patients in institutions without many clinical trial opportunities,” Sheffield explains.
Clearly communicating these benefits is key to selling high-throughput centres to NHS organisations. Getting those organisations to buy-in is unlikely to be easy, but Sheffield remains optimistic about the future of clinical trials in the UK.
“I genuinely believe that we will be able to increase the number of trials because the NHS is such a good environment to do them in,” he says.
