Question
Asked by
To ask Her Majesty’s Government what steps they are taking to encourage clinical trials in the National Health Service.
My Lords, the Government are working to make the UK the best place in the world for health research. The NHS has a vital part to play in this, and the NHS Constitution recognises that. Our health research policy, Best Research for Best Health, will ensure that the NHS is fully equipped to make its contribution. It will ensure that we deliver our national ambition to double the number of patients taking part in clinical research trials in the next five years.
My Lords, I thank the Minister for his encouraging Answer. I declare an interest: I am a member of the Medical Research Council and associated with the best university doing research in life sciences and clinical medicine. Of course I agree that much has been done to improve the climate for clinical trials, but concerns were reported recently in the press and journals about the UK not realising the full potential of the NHS in clinical trials. We have strength in life sciences and the ability to translate research into clinical medicine. We have great strength in clinical databases, and with the advance of genomic medicine our biobanks will pay a major role. However, UK participation in global clinical trials has fallen from 6 per cent to 2 per cent. Sometimes we fail to recruit any patients for some international clinical trials. Nearly 35 per cent of sites fail to recruit any patients after trial set-up. Clinical trials in the NHS are suffering. Clinical trials are an important part of quality healthcare; does the Minister think that they should be part of quality accounts?
My Lords, I agree. Innovation in science, mostly within the NHS, has significantly improved the quality of care that our patients receive in the NHS. We have seen numerous examples of this in the past 60 years. However, we can always do more, and recruitment to clinical trials is important. As it stands, the operating framework within the NHS has the following three principles. All providers of NHS care will need to increase their participation in research. The national ambition is to double the number of patients taking part in clinical trials and other well designed research studies within five years. Strategic health authorities are expected to show that NHS trusts work with the National Institute of Health Research and its clinical research network to increase recruitment to clinical trials. On the issue of whether research indicators should be part of quality accounts, I sympathise that research is a reflection of quality and I have asked officials to look into that. If an indicator is identified, I have no doubt that we will consult the service on whether it should be part of the quality accounts.
I think we just heard from the Cross Benches.
My Lords, shall we hear the noble Lord first and then the noble Baroness?
My Lords, would the Minister accept that for many years the National Health Service has been regarded in the UK as an ideal environment in which to perform clinical trials and that the support that the Government have given to medical research is much appreciated? Is he able to say, however, what effect the EU clinical trials directive is likely to have in the long term on the performance of such trials? Is he aware that the very complex and at times tortuous requirements now imposed upon clinical trials for ethical reasons, particularly for multicentre trials, have led certain pharmaceutical companies to propose moving their trials overseas because of the difficulty of obtaining ethical approval?
My Lords, I am aware of the EU clinical trials directive and we have consulted our stakeholders here. The stakeholder to which the noble Lord refers, the pharmaceutical industry, has consistently confirmed that it is content with the broad thrust of the EU directive, since it reinforces systems and practices to which it already conforms. We are aware, however, that there have been some challenges for non-commercial trials and we are now working with our partners in research charities, the Medical Research Council and the National Institute for Health Research in universities, to understand these problems and resolve them.
My Lords, my question follows on very well from the last question. Is the Minister aware of the extreme difficulty encountered by consultants trying to do small-scale clinical research? I quote the example of a consultant dermatologist who wishes to try, on just four patients, a drug that has been widely accepted and used for 40 years without any problem. He wishes to try this on four lupus cases as he believes that it may have a use, but, under that EU directive, he finds himself stuck in the position that he has to fill in as many forms and deal with as much bureaucracy as if he were a major pharmaceutical company. I have raised this matter informally with the Minister’s department. This consultant’s trust cannot afford the money involved in all that bureaucracy, so cannot something be done to make it easier?
My Lords, I have already said that we shall be looking at the impact of the EU directive on non-commercial trials, but perhaps I may also say, in the context of bureaucracy, that a lot of reform has happened within the system. To name just a couple, we have created a UK regulatory and governance advice service which provides researchers, such as the consultant referred to, with free access to expert advice and information about regulation. We have also created the National Research Ethics Service, which facilitates and promotes ethical research by working to maintain a UK-wide system of ethical review via NHS research and ethics committees.
My Lords, the Minister must realise that a new academic registrar may spend the whole of his 12-month fellowship seeking approval for a particular research project and then have to leave. We have the longest average approval time for clinical trials in the whole of Europe. As a very eminent researcher, probably one of the greatest researchers in medicine in this country, and now a Minister in this House, surely he is in a position to speed things up and make conditions better for researchers here.
My Lords, I am grateful for the noble Baroness’s kind words. She asked what we need to do to reduce bureaucracy further. As I have said, we have reformed the system, but I agree that there is more to do. I am very grateful that she acknowledges the investment that the Government have made in creating 250 academic clinical fellowships across the country.
My Lords, is it worth emphasising to the public that patients involved in controlled clinical trials receive even better treatment than those not in the trials?
My Lords, I am grateful for the noble Lord’s intervention. I agree that the recruitment of patients for clinical trials has a tremendous impact on the quality of care that the NHS can provide in the future, compared with when patients do not take part in a clinical trial. I agree with the sentiment of the noble Lord’s question and I have no doubt that that message and culture need to be disseminated across the NHS.
My Lords, I declare an interest as a beneficiary of a cancer drug, Avastin, which is a standard treatment for colon cancers in the national health services of France, Germany and elsewhere in Europe. Why are Ministers not even permitting NICE to carry out trials on it in this country for this purpose, and when do they hope to give such permission?
My Lords, we have debated this issue in this House on numerous occasions. One output of the next-stage review was a reform of the way that we appraise, through NICE, evidence relating to certain drugs affecting certain conditions, colorectal cancer being one. I reassure the noble and learned Lord that NICE will be looking at these drugs as we collect more evidence, and some of that evidence will come from clinical trials involving the recruitment of patients on Avastin in this country. I have no doubt that, once the evidence is available, Avastin could be one of the many other drugs that our patients receive in the NHS.
I am sorry, my Lords, we have reached 30 minutes.