Cancer clinical trials in the UK – part I

The debate over the relative merits of the UK and US healthcare systems is rumbling on.  The truth is that different systems work in different ways, have different priorities and do different things well. Henry has already written about the difficulties of making comparisons about cancer care between different countries.

In spite of the criticisms, the NHS is a health system that we can be proud of. One of the most impressive achievements is the UK’s strong record in cancer clinical trials.

A recent article in the New York Times presented a gloomy picture of the situation for cancer trials in the USA. It described how only 3 per cent of US cancer patients take part in trials, discussed the fact that doctors are reluctant to enrol patients because they lose money, and suggested that the designs of many of the trials are poor.

Perhaps most worryingly of all, only one in five US cancer clinical trials ever publish the results they come up with.  This is a huge waste of time and money, and bad news for the patients who volunteered to take part.

So is the situation any better in the UK? Are cancer clinical trials in the NHS working? We would argue that they are.

Over a couple of posts, we thought we’d have a look at the strength of the way we do clinical trials in the UK.

Cancer trials are well designed

Clinical trials are large-scale, long-term experiments where patients are involved in testing new ways of treating disease. They can range from small studies that test new drugs in humans for the first time (called Phase 1 trials) to very large Phase 3 trials that test how well new ways of treating patients compare against existing treatments. There is more information about different trial types on CancerHelp UK.

The first thing when designing a good trial is to make sure that all the people who have an interest in the trial are involved from the start. Cancer research in the UK is very collaborative – researchers, doctors and cancer charities have long worked together to share information and plan their research. This work is co-ordinated by the National Cancer Research Institute (NCRI) and the National Cancer Research Network (NCRN).

A key job of the NCRN is to support a number of Clinical Studies Groups. Each of these groups brings together a broad range of experts in one type of cancer or one research area. They keep an eye on any existing clinical trials going on in that cancer. They also develop new ideas for trials and work with organisations like us who will help pay for trials.

The members of these groups make sure that different trials are not duplicating effort. Each cancer trial that runs in the UK should investigate a question that everyone wants answered, without repeating work that is already being done.

Once the experts have agreed that a trial is important, someone then has to take on the job of designing the trial. This person –  the lead investigator – develops the trial in partnership with staff in a dedicated Clinical Trials Unit.

The lead investigator also needs to find an organisation that is willing to pay for the research. The funding could come from a government funding agency, from a charity like us or from a pharmaceutical company.

If the lead investigator applies to Cancer Research UK for funding, the grant application will be sent to one of our funding committees. The committee will look at how the trial is going to be organised, whether the money requested is justified and what impact the trial will have on patients with cancer.

The trial won’t get funded unless it is likely to be able to answer important and relevant questions about cancer. As Julie Hearn, head of the Clinical Trials team at Cancer Research UK, explains – “The more likely it is that the trial will change the way that patients with cancer are treated in the NHS, the more likely we are to support the trial.”

The lead investigator always hopes that the trial will generate a really exciting new finding. But sometimes negative results can be just as important. A large trial might show that, for example, a new drug didn’t work quite as well as the current standard of treatment.

“That would count as a negative result,” says Hearn, “but it could be a result that prevents patients from undergoing unnecessary and often unpleasant treatments. And it could save the NHS millions of pounds if it showed that there was no benefit in introducing a new drug.”

Cancer trials are well managed

As well as convincing a funding agency that the trial will answer an important question, the lead investigator must also ensure that the trial is ethically acceptable, and that it will be well-managed once it starts.

The most important factor is the safety and welfare of the patients who volunteer to take part. The trial has to be approved by the National Research Ethics Service and by the local ethics committee in each of the hospitals where the patients will be based. These committees check that the patients know exactly what they are letting themselves in for before they agree to take part.

The committee will check that the forms that patients have to sign make sense, and that they explain exactly what will happen in the trial. Doctors must not overplay the benefits of the trial when they ask their patients to take part. They must also let them know about all the possible side-effects of any treatments.

A clinical trial is a very complicated project to run. You might be collecting data from hospitals or GP surgeries all over the country or even beyond. You have to make sure that the confidential data from patients is dealt with correctly. You need to know exactly what has happened to every patient that receives the new treatment – and be ready to react if problems arise. Trials generate vast amounts of data which need to be collected, stored and analysed.

Clinical Trials Units exist to run the trials and manage the data. These Units bring together experts in statistics, data management, IT and administration. Cancer Research UK funds seven cancer trials units in the UK specialising in adult cancer, and one focusing on childhood cancer.  Most of the trials that we fund are run by one of these units.

There is one final stage for getting a trial started. Once the funding is in place, and once the Clinical Trials Unit is prepared for the deluge of data, someone needs to take overall responsibility for how the trial is run. This is the trial Sponsor, and the buck stops with them.

The Sponsor is prepared to stand up and say that all aspects of the trial are being managed and governed properly. The Sponsor is one of the organisations that is involved in running the trial, and it is usually the University where the lead investigator or the Clinical Trials Unit is based.

The end of the story?

The UK can be proud of its well-designed and well-managed cancer clinical trials. But this is only part of the story. Here’s our next post on clinical trials, where we will look at the importance of two other parts of the process – the NHS and the patients themselves.

Simon Vincent, Head of Personal Awards and Training