Cancer clinical trials in the UK – part 2

In a recent post, we started to show why the UK has a strong record in running high-quality cancer clinical trials. We explained that trials have to be designed well, so that they answer important questions. They are also managed effectively, thanks to the support of a network of Clinical Trials Units.

Here are two more reasons why the UK is a good place to run cancer trials.

The NHS is fully behind cancer trials

As we discussed last time, a clinical trial needs funding, ethical approval,  a Clinical Trials Unit to handle data, and a Sponsor. So is that it? Can the trial begin now?

Not yet. There is one more crucial partner in the process.

The NHS is the key to the success of clinical trials in the UK. Almost all cancer patients will be diagnosed and treated within the NHS. And the lead investigators running most trials, and the medical staff treating the patients as part of the trial, will all be working for the NHS.

Because we have a single healthcare system, patients can enrol in trials across the UK. Local GPs can share information with the investigators running the trial. And when a trial finishes and comes up with an answer, the new way of treating patients can be rolled out for every cancer patient.

The NHS is geared up to support research. In fact, the recent NHS Constitution states that:

Research is a core part of the NHS. Research enables the NHS to improve the current and future health of the people it serves.

The NHS supports clinical trials by meeting some of the running costs. This only happens if a trial is recognised as being of high quality – in other words, if it has been through all the steps described in our earlier post. Any trial that Cancer Research UK funds is automatically eligible for financial support from the NHS.

So all parts of the process work together to make sure that trials are well designed, well managed, well governed, and asking important questions that will improve the way we treat patients cancer. But there’s still one more group of people involved – the patients themselves.

Patients get involved in trials

Even if the trial is perfect, the research won’t happen unless patients are prepared to take part. This is where cancer trials in the UK are leading the way.

Cancer clinical trials are co-ordinated by the National Cancer Research Network. This was set up by the Department of Health in England in 2001 and one of its aims was to double the number of patients in cancer trials. In fact, it has done even better than hoped, and now 12 per cent of all patients diagnosed with cancer get involved in trials.

Indeed, the NCRN has been so successful that researchers working in other areas are using the model and establishing their own networks. The UK Clinical Research Collaboration is bringing researchers on other diseases together to work with the NHS. The aims are to make clinical trials more effective and to increase the number of patients taking part.

The NHS has an important part to play, too. Its Constitution says that it will promote medical research by letting patients know how they can get involved.

The NHS will do all it can to ensure that patients, from every part of England, are made aware of research that is of particular relevance to them. The NHS is therefore putting in place procedures to ensure that patients are notified of opportunities to join in relevant ethically approved research and will be free to choose whether they wish to do so.

Of course, patients need to know about trials before they can decide whether to join in. We provide information through our CancerHelp UK site, including a database of the majority of cancer trials in the UK. Patients can then talk to their GPs or specialists to see if they are eligible to take part in the trial.

In spite of this co-ordination and information, there are many patients who might benefit from taking part in a trial, but don’t know about the opportunity. Currently, researchers need to apply to local GP surgeries to ask them whether they have any patients who might fit the bill, but surgeries are often busy and find it difficult to respond.

Hilary Tovey, a Policy Manager at Cancer Research UK, says “We would like to see a system where researchers can more easily access anonymised information about patients. They could work with the patient’s GP to identify people who they think might benefit from taking part in a trial.”

Still room for improvement

All these factors add up to a strong case for the UK being one of the best places in the world for cancer trials. But there are concerns that complicated red-tape and a high cost of living mean that trials are cheaper and easier to run overseas. Combined with a slow uptake of new medicines by the NHS, this can mean that drug companies are less likely to choose the UK as the place to run their trials.

To counter this, the Government recently set up a new Office of Life Sciences, which is looking at how the UK can be made a more attractive place for pharmaceutical companies to develop and test new therapies. The OLS is also investigating whether the NHS can be made more ‘innovation-friendly’, to improve the uptake of new medicines and other technologies.

The amount of regulation of running trials in the UK has also increased over the past few years. The UK has implemented an EU Directive that governs how clinical trials are run. The Directive has two very important aims: to improve the safety of patients in trials, and to standardise the way that trials are run in all EU countries, so that it is easier to run trials in more than one country.

But a downside to the Directive is that trials take longer to set up and are more complicated to run, because there are many more regulations to think about. Julie Hearn, the head of the Clinical Trials team at Cancer Research UK, says, ‘We are keeping a close eye on how the Directive is affecting our clinical trials. We have asked the European Commission to take another look at this Directive and to cut the bureaucracy involved in running trials, whilst still making sure that the patients that take part are safe.’

A record to be proud of

But even though things are not perfect, the UK can certainly be proud of its record in clinical trials, and cancer clinical trials in particular. Cancer Research UK’s trials are regularly highlighted as being world-leading at the largest gathering of cancer doctors in the world, the annual meeting of the American Society of Clinical Oncologists.

This year, for instance, the meeting heard about the ABC02 trial. This trial of 400 patients with advanced gallbladder and bile duct cancer showed that combining two chemotherapy drugs improves their survival by a third. These are very difficult cancers to treat, and this was the first trial in the world that showed any benefits. It is likely to lead to a new ‘gold standard’ for treating bile duct cancer not only in the UK but across the world.

These important results, and many others like them, have only been possible because of many people working together on high-quality trials that answer important questions. Patients, doctors, nurses and scientists, supported by universities, hospitals, Governments and charities, all work in partnership with the NHS to make the UK a great place to do clinical trials.

Simon Vincent, Head of Personal Awards and Training