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Clinical trials and Parliamentary tribulations

by Dan Bridge | Analysis

25 April 2013

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Professor Peter Johnson representing Cancer Research UK

Professor Peter Johnson representing Cancer Research UK

Clinical trials are vital – they’re how we know which treatments work, how best to use them, and what the side effects are. So running trials quickly and effectively, and sharing their results, is essential if we’re to continue our progress in beating cancer.

On Monday, the House of Commons Science and Technology Committee – a group of MPs that scrutinises the Government’s science policies – held an evidence session with academic and charitable research funders, to examine issues around clinical trials.

Our chief clinician, Professor Peter Johnson, was invited to give our view on what needs to be done, alongside representatives from the Wellcome Trust, the Medical Research Council and Association of Medical Research Charities.

You can watch the entire session on the Government’s website here.

Vibrant environment

Peter started out by outlining the strengths of clinical research in the NHS.

“We have a very vibrant clinical research environment in the UK,” he told the MPs, “and we have made enormous progress over the past 10 years with concerted investment into this area.”

But he pointed out that the EU regulation – called the Clinical Trials Directive – has led to “well-documented hurdles”.

“Certainly the European Clinical Trials Directive – when it was first implemented – was a major impediment to research,” he said, recapping the problems we’ve outlined previously on this blog. He also stressed the need for “a continuous emphasis on improvement,” to make it less bureaucratic, to set up new studies and to run existing ones.

It was clear from the evidence presented by all four witnesses that there’s a pressing need to improve the regulatory system. It’s expensive and time consuming to get over the regulatory hurdles to run studies that are the driving force behind improvements in cancer survival. And we think our supporters’ money should be spent on research rather than on red tape.

Thankfully, having been calling for reform for many years, it now looks as though proposals released last year – known as the EU Clinical Trials Regulation – will make it much easier to set up and run clinical trials in the UK.

Reporting clinical trials

Another important area the Committee is exploring is transparency in reporting clinical trial results. Ensuring that all trials publish the results of their studies is vital to ensure that doctors and patients are able to make proper, informed, evidence-based decisions about their treatments. It also allows the research community to understand what research has already taken place, so that we can channel resources into asking the most relevant research questions.

These issues have long been the subject of scrutiny from organisations like the Cochrane Collaboration and Sense About Science, and the subject of a recent book by doctor and journalist Ben Goldacre, author of the Bad Science blog.

And earlier this year, Cancer Research UK, together with several other medical research funders, signed up to the All Trials campaign, which is calling for greater transparency in clinical trials.

The fact our research is directly funded by you, the public, makes it even more important to ensure the results of Cancer Research UK funded work is published – and we take this very seriously. As we said in our written evidence to the committee, we directly fund over 240 clinical studies in the UK, and over the past 10 years we’ve supported or endorsed 323 trials. Of these 203 have been published and the remaining 120 are being analysed.

We also run a clinical trials’ database which aims to cover all UK cancer trials. The database includes details of approximately 500 studies recruiting people in UK, and more than 400 summaries of study results. In 2012 we added 83 results’ summaries, including 25 from studies that had received funding from Cancer Research UK and 15 that were sponsored by pharmaceutical companies.

Peter went on to outline how we already share data to help others understand medicines better. We think there are several opportunities for the whole medical research community to help make the information from trials available to benefit researchers, doctors and, most importantly, patients. And we’re keen to work with others to help improve things.

But we need to ensure that we balance the need for greater transparency with the need to get high-quality cancer studies up and running in the UK. We think that charities, academia and industry should work together to produce a solution that benefits everyone, rather than introducing further measures into the proposed EU Clinical Trials Regulation, which may not take into account the complexities of running trials.

Industry commitment

Our session was followed by a panel of representatives from industry, including the drug companies GlaxoSmithKline and Roche, and the Association of the British Pharmaceutical Industry. Dr Ben Goldacre also gave evidence at this session.

The panel was asked to focus on the issue of transparency, and it was interesting to hear commitments to improve access to results and data from trials. We’ll be taking an active interest in how these initiatives develop.

The Committee will produce a report with its findings, and we’ll be keen to see what recommendations are made in this complex yet vitally important area.

You can follow the evidence as it unfolds on the Select Committee’s website.