If you had gone back in time to early 2011 and reviewed the early incarnations of the health and social care bill, you would have found that research had scant consideration.
Fast-forward to today and, amidst all the furore encircling current health policy, we have one really important success – research is now a statutory duty for everyone in the NHS from the secretary of state downwards. You might ask why this matters. Research is not just about laying down scientific advance for the future, important though that is, it is central to improving the quality of the health service to patients now. So it is a major win to have a research duty across the NHS.
However we also know that the NHS has been a “late and slow adopter” of innovation and technology and this despite the fact that we know the UK punches above its weight in sciences. We have 3% of the world’s population but 14% of the world’s research citations. Our science base is enviable.
However look at this – compared with our record on citations we have only 2% of the world’s patents. And from having 6% of patients enrolled in clinical trials worldwide in 2000, the UK has fallen to 2% (in 2006). We may be doing the research, but we are not as successful in translating that research into products and services, and the NHS is slower than any of us would like in taking up these new offers. It seems we have a vibrant research base in biomedical sciences, but frustrating delay in getting those benefits to patients.
Charities witness these delays at first hand. Our member charities invest over £1bn each year into health research – approximately a third of the total UK public investment. Money donated by patients, carers and their families in the hope of finding a cure or easing the symptoms of diseases. Charities in turn invest this money in basic science and translational research, with the aim of speeding up the time it takes for advances to go from the lab to the bedside. But the process is long and frustrating; I think there are three blockages.
Developing a culture of research
Firstly, there is a cultural problem – the statutory duty is a great step, but it is only a first step. Whilst there are some brilliant examples of research in the NHS, all organisations need to understand that they have this duty, and then they need to embrace it: in effect, turn that duty into an opportunity. This is more difficult that it sounds. Despite its name, the NHS is not a national service at all, but a highly atomised set of local organisations knitted together into a complex web. Top down instruction to support research will only go so far in such a web. Clinicians and scientists have got to want to pursue a research agenda, and patients can be a helpful catalyst here.
AMRC polled nearly 1,000 people, and found that 97% believe it is important that the NHS supports research and 72% want their doctor to offer them the chance to participate in research trials. In fact, our charities tell us that they have large numbers of patients who want to take part in clinical trials but have no idea how to get on one.
So patients can develop a research culture in local NHS organisations by asking about research opportunities, and the more patients enquire, the more that clinicians will provide.
Sorting permissions – the 70 days approvals target
The second blockage is the bureaucracy that surrounds research permissions. Proper administration of research is important, and projects need to pass the appropriate scientific and ethical hurdles to be approved. However, it takes – on average – 140 days to obtain NHS approvals, prior to recruiting the first patient to a clinical trial, and multi-site trials often need to gain separate permissions from each local NHS institution.
In response to an Academy of Medical Sciences report on the challenges of research in the UK, the Department of Health has set up the Health Research Authority (HRA) to help to streamline the process. The HRA is welcome, but it has a big job to do. If it is to do what the academy envisages, it needs to simplify the regulation of health research and co-ordinate NHS local R&D consents. A new target of 70 days has been set for recruiting the first patient to a clinical trial. This is a bold aim but it needs to be more than just an aspiration. We need a streamlining of the process and then, on the basis of ‘what gets measured gets done’, we need a tracking mechanism that ensures that regulators and institutions are meeting the 70 day target.
Licensing risks and benefits
The final blockage is the process of licensing and approving drugs. Once clinical trials are complete, the process needs to be more discriminatory. All new drugs represent a balance of risk and benefit, and we need a licencing and approvals system that rewards innovation. It needs to recognise that the trade off between risk and benefit should be different for the nth statin to be licenced than for a brand new drug that may help cure a condition like motor neurone disease, where few therapies exist. Once again, patients are important partners in the assessment of that risk.
A recent citizens’ jury convened by University of Glamorgan and Genetic Alliance UK, found that patients were adept at understanding the higher risks associated with therapies for rare or serious conditions and want the chance to take those risks in pursuit of care or cure. Clinicians, scientists and regulators need to respect the views of these patients as they consider the approval of new drugs.
If we get it right, the research duty is really a massive opportunity to improve the way the NHS uses the fruits of medical research to help patients. To paraphrase the words of the NHS chief executive in his 2011 innovation report, we are not lacking innovation we are lacking adoption mechanisms. It’s time to stop talking and start doing.
A version of this article appears in Public Service Review: UK Science and Technology, issue 6