EU regulation must strike balance between safety and progress

Cancer survivor Nigel Lewis-Baker

“I’ve been on two clinical trials. The first one was a 14 month vaccine offered when my current treatment was beginning to fail. When this trial ended I took part in a second trial which produced horrendous side-effects.

“However, it was worth all the discomfort to progress treatment and, eventually, get some personal benefit, and I would do it all again. I am currently waiting for another suitable trial to become available.

“Clinical trials are essential to developing future treatments, and I would not be here now if others had not co-operated in the past. Not only that but they give me a feeling of being more in control and creating something useful out of my situation.

“It is sometimes difficult to keep positive, but trials are a tremendous help and the close scrutiny and care I get also give me comfort and confidence to carry on.”

-Nigel Lewis-Baker, cancer survivor

Nigel’s experience, and reasons for taking part in trials, highlights the importance of clinical trials in making progress against cancer.

His story features prominently in our new report ‘Supporting research, protecting patients‘, which sets out how UK clinical research is being hindered by a key piece of European legislation, and what can be done to change this situation.

Clinical trials are the key to working out whether new treatments are safe and effective. And, because they involve patients, there are justifiably strict and clear regulations about how trials are set up and run, and what researchers can – and can’t – do.

These regulations keep patients safe, and make sure that trials’ results are scientifically accurate – with the ultimate aim of improving things for patients in future.

Delicate balance

But regulating clinical research is a balancing act.

On the one hand, the rules should ensure patients are kept safe through proper regulation and scrutiny. On the other, they shouldn’t unnecessarily delay researchers from getting on with their work.

Too much red tape means they can’t get on with running their trials and researching new treatments – and can also divert limited resources to dealing with bureaucracy instead of science.

In 2001, the European Union (EU) introduced a piece of legislation called the Clinical Trials Directive as a way to harmonise clinical research regulation across the continent.

One of its key aims was to make it easier to carry out research across national borders – something that’s becoming increasingly important in clinical research.

In recent years, drug regulators have asked for more and more data to prove the safety and effectiveness of new treatments. This has meant trials have needed to recruit large numbers of patients.

And the easiest way to do this – particularly in rarer diseases or for rare genetic forms of common diseases – is to run trials collaboratively across several countries.

Flawed legislation

Unfortunately, the Directive failed in its attempt to harmonise trial regulation and has instead created a fragmented system in each European country. It also created several regulatory problems which have damaged UK researchers’ ability to run clinical trials.

At Cancer Research UK, we aim to carry out as much high-quality clinical research as we can. As a result, we’ve been concerned about the Directive’s effects on UK research.

For example, a 2008 report estimated that it could sometimes take more than a year to get approval to carry out a trial. And as we said in a report last year, after funding for a study has been agreed, it takes an average of 621 days to recruit the first patient.

Clearly something needs to be done.

Thankfully, the EU has recognised the Directive’s problems and has set about the process of revising it to suit clinical researchers’ needs. We’ve been playing a key role in organising the research community to make specific calls on what we think needs changing.

Here’s an example of the sort of change that’s needed:

Much of the research that we fund aims to improve the use of existing drugs, whose effects our experienced clinicians and nurses have an excellent idea of.

Running trials to confirm these suspected effects is a very different thing to running a trial of a brand-new, unproven drug.

However, the Directive does a poor job of distinguishing between trials involving known medicines, and trials involving compounds being tested in humans for the first time.

What we want to see is a system that allows our researchers to perform such ‘low-risk’ research without too much red tape, without compromising patient safety for completely new products.

And we’ve got government support. In last year’s budget Chancellor George Osborne said, “In life sciences we will radically reduce the time it takes to get approval for clinical trials.”

With this support, we’re now going to take the issue to Europe and secure a revision that will benefit researchers in the UK.

Harmonising regulation across Europe is still something we want to see achieved in the Directive’s revision.

But we believe that if European policy makers get this right and reduce bureaucracy, it will allow our clinicians to do more high-quality research, to the same standards of patient safety, while allowing us to continue making progress in our vision of beating cancer.

Dan Bridge