As the birthplace of the industrial revolution, the West Midlands has a long history of innovation.
Today, the region maintains its reputation as an innovation powerhouse, spanning tech, manufacturing, digital, life sciences and beyond.
Based at the University of Birmingham, the Cancer Research UK Clinical Trials Unit (CRCTU) is a leading light in the clinical trials space.
The unit has a presence of nearly 400 sites in more than 20 countries, delivering innovative trials to support the development of new treatments for cancer, rare diseases, Covid and more.
Professor Pamela Kearns is Director of the CRCTU and its clinical lead for paediatric cancers.
“We are the biggest cancer clinical trials unit in Europe, with particular expertise around small patient populations and delivering trials with complex, innovative designs,” Prof. Kearns tells Health Tech World.
“We work with industry in a very unique way to meet both the needs of industry and the needs of patients.”
This unique relationship with the industry is one of many ways the CRCTU has evolved its operations in recent years.
Historically, CRCTU would conduct purely academic trials.
Now, while every trial is academic-led and sponsored by the University of Birmingham CRCTU is focussed on improving the standard of care for patients.
They have moved into a new space which they call ‘fit for filing.’
“These are industry-collaborative studies, where we work with industry to design a study that’s answering an important question for our patients.
“But it is also designed in a way that the data that comes out at the other end could be used to support applications for marketing authorisation.
“That is a different way of conducting academic clinical trials, with an additional focus on the data and document package needed by the regulators.”
The unit has established the Industry Trials Hub at the Birmingham Health Innovation Campus to work with industry and with regulators such as the MHRA, EMA and FDA to ensure that each study is designed and delivered with marketing authorisation in mind.
The structure of the trials has evolved, too, with the unit working much more efficiently to deliver this outcome.
Traditionally, clinical trials for a new drug follow three phases, beginning with the initial safety study and concluding with a randomised trial comparing the new drug with the standard of care.
Now, the unit has moved on to ‘adaptive design trials’ where they can move seamlessly from one phase to the next, drastically speeding up the process.
“And in addition to that, we can investigate a lot of different drugs in the same study,” Prof. Kearns says.
“One example is our non-small cell lung cancer trial. This disease is very difficult to treat.
“Patients were screened according to a molecular fingerprint. Depending on what that fingerprint looked like, they were placed into one of over 20 different arms.
“We collaborated with different industry partners, and asked very rapid questions to establish whether each drug or combination was useful in the disease.
“So we’ve got efficiency in both ways: we can look at more drugs in one study and we can do more than one phase in a study.
“If a rare disease drug goes through this process and shows a good outcome, the regulators will consider it for marketing authorisation straight away, rather than doing a big trial.”
Rare diseases present unique challenges to triallists.
The small number of patients on any one trial can be dispersed all over the country. However, it is often only cost-effective for a centre to recruit in larger numbers.
To address this, the unit fosters relationships with sites that have an interest in their work, making them more open to hosting the trials.
Designing studies with the patient community in mind is crucial.
If patients are interested in the study, clinicians will be too.
The next step is to ensure that the study is designed in a way that is attractive to patients and there are no unnecessary barriers to them participating.
“As a triallist, you can very easily put something into a trial that puts patients off signing the consent form”, Prof. Kearns says.
“It might take them out of school or require them to take lots of time away from work.
“So working with patients to make the trial acceptable is really important, particularly when you’ve got small numbers.”
The unit is also working to tackle racial disparity in clinical research, where groups most at risk of health complications are often under-represented.
The CRCTU has teamed up with Birmingham Health Partners to develop a more effective way to run clinical trials with these groups.
The region’s ethnically and culturally diverse demographic is very attractive to companies working in drug and medical device development as it ensures the data is from a ‘real world’ patient population.
Prof. Kearns says:
“We’re also working very closely with our local community about how we can increase accessibility to get that diverse population into our trials.”
The unit’s efforts will help to address the wider recruitment challenge affecting clinical trials across the UK.
A recent report revealed a 44 per cent drop in the number of participants recruited to trials over the past five years.
And over the same period, the number of trials initiated per year fell by 41 per cent.
The government has launched an independent clinical review to address this and other challenges facing triallists today.
George Freeman, Minister for State at the new Department for Science, Innovation and Technology, said:
“Commercial clinical trials are absolutely vital to both our UK life sciences sector and widening NHS patient access to innovative medicines all across the UK.
“It is vital that we act to rebuild competitiveness.”
Prof. Kearns believes that a lot more should be done to attract clinical trials investment in a country with the expertise and infrastructure to excel on the international stage.
“The pharmaceutical industry and academic community are frustrated by how difficult it is to open clinical trials within our NHS at the moment.
“What we need to look very closely at how we set up trials in the NHS to make it much more part of the clinical pathway.
“If the trusts could invest their time and effort into every patient being offered the opportunity to be part of a clinical research pathway, whether it’s a trial or using their data to improve outcomes, we would be an incredible powerhouse for science in this country.”
Whatever the independent report finds, it will be up to the likes of the CRCTU to deliver on the government’s promises.
The unit will continue to adapt its practices as it strives to meet the demands of a changing health landscape.
But if the West Midlands’ industry is prepared for one thing, it’s change.