Researchers face considerable paperwork when setting up trials

Without clinical trials, there would be no new cancer treatments. And there are few better places to set up a clinical trial than in the UK.

As a result we have one of the highest rates of participation in trials anywhere in the world. And our clinical researchers – often working in partnership with colleagues in other countries – have been behind many of the important treatment advances in recent times.

But over the years, the way the European Union regulates clinical trials across the continent (known as the European Clinical Trials Directive) has come in for criticism – much of which we agree with.

Thankfully, in response, the European Commission has now announced (pdf) proposals aimed at addressing these issues.

These proposals will soon be debated by MEPs in the European Parliament, and the Governments of the member states, before becoming law.

Today, we’ve published our thoughts on the Commission’s proposals (pdf), with the aim of influencing the debate and hopefully strengthening the resulting regulation.

In general, we’re broadly supportive of the proposals, and pleased that a lot of the criticism has been taken on board.

But there are still a few things we think could be improved, as we’ll see below. Making clinical research as effective as possible is vital if we’re to translate laboratory breakthroughs into treatments for patients.

Trials to beat cancer

Clinical trials are the best way to understand whether new treatments are both safe and effective, and this necessarily involves trying new treatment in patients for the first time.

So it’s understandable that the way trials are regulated is very strict – patients taking part in a trial need to be kept safe, and the results that a trial produces need to be scientifically valid.

But as we’ve said before, we think the current legislation is hindering researchers (a point that others agree with). And ultimately, this can slow progress, meaning that patients miss out.

Working together across Europe

EU Clinical Trials Directive governs how researchers across Europe (including the UK) go about setting up and running clinical trials. Broadly speaking, being part of a Europe-wide system like this is extremely useful to UK researchers and patients.

Being part of the European system means that organisations like Cancer Research UK should be able to easily run trials with other organisations based in other EU countries. This means that our researchers can work with other leading experts from around Europe, and recruit more patients onto such studies.

This is particularly useful for rarer cancers which affect such a small number of people. Collaboration allows patients from across several countries to take part in a single trial in sufficient number. But in practice, this isn’t happening to the degree we’d like.

What are the key issues?

The existing legislation allows different EU countries to interpret the law as they see fit. And inevitably, over time, this has led to different systems springing up in different EU member states.

This makes it extremely challenging for our researchers when they want to collaborate – they have to take multiple sets of rules into account, and fill in a large amount of paperwork, which means trials with partners elsewhere in the EU can’t happen as quickly as we’d like.

A second challenge arises when you appreciate that, as well as testing brand new, ‘first-in-man’ treatments, clinical trials can also test existing therapies in new settings – for example testing a ‘bowel cancer’ drug in stomach cancer patients.

In these cases, a lot of the hard work (on safety, side effects etc) has already been done first time around.

We’d like to see the Clinical Trials Directive differentiate between these two situations, so that new ways of using existing drugs can be tested faster, and benefit patients quicker.

What’s being proposed to fix things?

As far as the first issue – fragmentation – goes, the Commission has proposed that the new system be put directly onto the statute books of each European member state. This could potentially solve the problem, since there’s no wriggle room for different versions of the law in different countries.

The proposed system also aims to streamline the way researchers apply to run clinical trials, which we’re also pleased about.

With the second issue we outlined, there’s still some way to go. We want the new system to take into account previous trials of treatment, and to adapt things accordingly. This would mean that clinicians could do more work to understand how best to use the treatments that we already have, or find out how to use established therapies in new areas.

This is especially important as new ‘targeted’ therapies are rolled out. These drugs target common molecular defects found inside cancer cells. So what works in some types of bowel cancer may work equally well in breast cancers driven by the same faulty molecules. We urgently need to test this idea. So we need to get this point right.

What next?

We’ll be making sure MEPs and the Government see our report, as well as others interested in this matter, and try to make sure they reflect on what we’ve said, when the time to debate these issues comes. We’re hopeful that we can make our case persuasively.

By getting the level of regulation right, patients and the public can continue to reap the benefits from the world-class research taking place throughout the UK and Europe – much of which is so generously funded by our supporters.


Image by Kaptain Kobold via Flickr