Are commercial trials of new drugs and treatments important to the NHS?

Posted on April 4, 2012 by

1


The Guardian hosted an interesting debate online on Friday afternoon looking at the role of commercial trials in the NHS. It touched on why commercial trials are important to the NHS and the role they play in developing the drugs and treatments we use, there was a lot of conversation about access to patient data for research and how this could be achieved safely and securely – the new Clinical Practice Research Datalink launched on Thursday. The discussion also covered issues of trust – do patients want to be involved in research? – and ensuring that trials of new treatments are patient focused, delivering better care.

The guardian will produce a round up next week. But in the meantime, you can read the whole thing if you scroll down this page. It’s rather tricky to follow but well worth a read – I’ve pulled out some of the interesting bits of the discussion below:

Those taking part included:

On the value of commercial investment in trials of new drugs or treatments in the NHS:

Sharmila Nebhrajani from AMRC:

Almost all drugs in use in the UK today have been developed by pharmaceutical companies. On average a recent study estimated it takes around £600m to produce a drug and we simply could not fund that level of research and development from public funds. I think the key is to find a way for research funders (charities, industry and government) to work together to collaborate more effectively to produce new drugs and therapies quicker.

Monty Mythen from UCL

I worked with a commercial company to pioneer the Oesophageal Doppler that monitors blood flow during surgery – a device that recently hit the headlines when it was recommended by NICE as a way of potentially saving the NHS millions of pounds by improving the speed and quality of recovery from major surgery.

Kate Law from Cancer Research UK gave a good example of how charity and industry collaborate to bring a drug to market. The benefits being that charities can plumb the money raised from owning the intellectual property of a successful drug straight back into more research.

I can think of a number of cancer drugs whose benefit was demonstrated in cemmercial trialse.g. Herceptin for bresat cancer. However, I will also highlight a drug called Temozolomide which is used across the world for patients with brain tumours. It was developed initially by CR-UK scientists and, given the costs of drug development, was then licensed to a pharmacuetical company. CR-UK retains IP and has benefitted from millions of pounds being returned to the charity which have then been used to support our research. I see this as a good eaxmple of academic/charity/industry partnership that benefits everyone.

And Jonathan Sheffield who leads the NIHR clinical research network expanded on the reason commercial investment in trials is a valuable part of drug development and why we might want that to happen in the UK, in the NHS:

The public sector does not have the resource to invest that heavily in drug development and so we need private finance to deliver this work. The more development in the UK the better for the economy and hence the better for tax return and more money for public investment in the NHS.

Sally Davies from the Department of Health picked up a theme that was echoed throughout the discussion – that research taking place in the NHS was good for patients – meaning they have access to the latest, best healthcare and may even get earlier access to cutting edge treatments when they are involved in trials:

There is a huge benefit to patients from commercial research being conducted in the NHS, others have commented on this. It gives early access to cutting edge treatments and technologies,and ensures best care for patients throughout the study.

And as Peter Brindle emphasised:

..the focus of the research – whether paid for by industry, by charities or the NHS, is always the patient

This was echoed by a Commercial Research Manager based in the Research & Innovation Department at University Hospitals Bristol NHS Foundation Trust who joined the debate and talked about how they re-invest some of the income from commercial trials to build research capacity in the trust

We have developed a system whereby we split the income we receive from commercial trials and ensure some of it is retained by Research & Innovation to re-invest in research in the Trust and build capacity. The way we cost commercial trials and subsequently manage the income has become a lot more transparent. I would agree with previous comments that at the end of the day the main focus is on the patients rather then the potential income. UH Bristol supports commercial research where it is of a high standard and of benefit to our patients and the Trust as a whole.

On the use of patient data for research:

Sally davies mentioned the launch of the clinical practice research datalink – which launched on Friday. She also mentioned the revision of the EU data protection directive which the UK is currently feeding into saying

“For research, the measures in the proposal look proportionate. Our concern is how this will be put into practice. We will work to get the best outcome for patients, GPs and the health service.”

We recently supported a joint statement outlining our concerns about the planned revision and the impact the proposed changes might have on health research.

Tom Moberly, deputy news editor of GP Magazine raised security around the CPRD:

“Will there be stricter rules in place for researchers wanting to use the Clinical Practice Research Datalink? Do rules need tightening? I’d be interested to hear people thoughts.”

Which Jonathan Sheffield tackled:

“We are very conscious of individuals worries. Hence there will be a public consultation on proposed changes to the NHS constitution to ensure public understanding on this change. The CPRD will be an annonymised link. All the information governance safeguards will be checked by the information commissioner to ensure the very highest standards of practice.”

The consultation was announced as part of the life sciences strategy on 5 December and we expect it in the autumn.

And Peter Weissberg from the British Heart Foundation neatly summed up the dangers of simplifying down to good guys and bad guys:

I am a little concerned by the implication behind the question which is that there are two types of NHS clinicians out there. Those who simply deliver health care – the good guys, and those who undertake research – the bad guys, and that patients need protecting from the latter. The whole ethos of the new NHS environment is that good clinical practice necessarily encompasses research. The people who deliver your clinical care are exactly the same people who seek to include you in a research project, be it academically or commercially driven. It is no one’s interests, and certainly not the researcher’s for data to be inappropriately used.

The new Health & Social Care Act (as of 27 March) and the emphasis this puts on research as a core role of the NHS also got a mention.

Sharmila Nebhrajani:

The new law is ground breaking – it really does for the first time place research at the very heart of the NHS. It really should be called the National Health and Research Service. So having that statutory duty is a great start. And because of the universal service provided by the NHS the data and patient involvement in research we can do here in the UK really does make us potential leaders. The US for example comes to the NHS for research data it does not have itself. We can be world leaders here.

Jonathan Sheffield:

For the first time there is a duty for managers at all levels in the NHS to support research. That means from the Health Secretary downwards their is a legal responsibility to open the NHS to research… … That is now a clear responsibility not just for healthcare professionals but also for healthcare managers.

The discussion also went on to cover:

  • the mistrust of commercial investment in trials and reasons for this
  • the demand from patients to be involved in research – in an Ipos MORI poll we commissioned last year, 80% of the public said they would like the opportunity to allow access to their data for research and 72% wanted to be offered the chance to participate in trials.
  • the regulatory environment and the impact this has on how long it takes to get a trial off the ground and patients recruited
  • issues around the uptake of new innovations coming out of these trials and delays before these can become available to help patients across the NHS – David Nicholson’s review of innovation in the NHS Innovation, Health and Wealth: Accelerating adoption and diffusion in the NHS looks at some of the reasons for this slow uptake and sets out a plan to tackle them.
  • and how trials are changing as the drugs we develop are targeted to smaller and smaller groups of people. This is stratified or personalised medicine  where a drug may be effective for a specific genetic variant of a condition only. Will we need to develop new regulatory and approval processes to allow these drugs to be developed? And will diagnostic tests to identify those who could benefit from targeted treatment be developed alongside?
Posted in: Policy