Testing, testing with Anglia Ruskin

Dr Michael Harrison

How ARU's Clinical Trials Unit works with medics to answer important health questions

It's been nearly four years since Anglia Ruskin's Clinical Trials Unit opened its doors on the Chelmsford campus. Since then it has grown rapidly, working with companies and clinicians to test new drugs, services and devices.

John Orosky is very pleased to be sitting in the ARU Chelmsford clinic discussing his health with clinician Dr Gowrie Balasubramaniam. Gowrie may have some good news for a seemingly intractable problem that has been plaguing John the last few years: how to treat his crippling attacks of gout when traditional gout medicines are out of bounds at full strength, due to his chronic kidney disease. The drugs for gout harm the kidneys – they would put his life in danger.

This clash of treatments is not an uncommon problem: one in ten of the over 80s have chronic kidney disease, while gout – a painful inflammation of the joints – is on the increase with a rise of 27% in the last five years, and now affects 1.3 million people in the UK.

Wanting to alleviate the pain of gout sufferers with kidney disease, Gowrie and colleagues in the kidney unit at Southend University Hospital had the idea for a trial for of a drug called Anakinra for these patients. Anakinra is normally used for rheumatoid arthritis, but GPs are increasingly starting to prescribe it as it reduces inflammation and does not damage the kidneys. 'Anakinra stops the action of a chemical called interleukin-1 which plays an important role in the acute gout attack, and we think it might be a better alternative to steroid treatment,' says Gowrie. The problem is that there have been no trials for its use for gout – it has not been proven to be either safe or effective, nor compared with other options.

The good news is that the ARU Clinical Trials Unit and Southend Hospital recently won funding to run the pilot trial. The funder is the National Institute for Health Research (NIHR), Britain’s biggest government funder. It is to be conducted with seven hospitals and is patient-focused, and will compare Anakinra with steroids – the only other safe treatment, but that is not without its drawbacks.

There are few places in Suffolk and Essex which can conduct clinical trials – whether for new drugs, devices or other health services. This is one reason ARU set up its new Clinical Trials Unit, although it is not restricted by geography. Its Director, Michael Harrison, explains its special niche: 'Since launching in the summer of 2014, we have created a service that has a particular focus on supporting smaller organisations conduct trials: we take special care in helping clinicians and companies every step of the way. We can advise to a company with a small budget about whether there is scope to run their study.'

For SMEs, that’s the biggest difference, explains Michael. 'We are one of the only Clinical Trials Unit (CTU) in the country that isn’t attached to a large medical institute or embedded within a hospital.'

The Unit is a research partnership between Anglia Ruskin's Postgraduate Medical Institute, NHS Trusts from Cambridgeshire, Essex and Hertfordshire, and industry partners. These NHS Trusts cover a local patient population of over three million.

Michael and his team provide all the tools and knowledge for running a clinical trial. Its true symbiosis: 'The hospitals and companies need the CTU to provide the infrastructure and expertise they don’t have locally,' explains Michael. Likewise, we need them to provide the trial ideas and patients. It is highly satisfying teamwork!'

The initial gout/kidney disease trial will work with 35 people and, most importantly, provide key information for a larger study. 'We hope the larger study will then go on to tell us which treatment may be better, safer and more cost-effective,' says Gowrie. 'We also hope this will be the first of many trials with ARCTU.'

The ARU Clinical Trials Unit specialises in working with SMEs all over the country and provides a tailor-made service that helps companies every step of the way. The staff at the Unit:

  • help clinicians develop ideas
  • support them in writing funding applications
  • source the right hospitals
  • give advice on the UK regulatory environment
  • create a randomisation programme
  • manage the trial’s database
  • oversee trial monitoring and site visits 
  • analyse the data and publish the results.

Find out more

For more information contact Clinical Trials Co-ordinator Trisha Parker on 01245 684938.