‘Scroll down’ for clinical trials

To begin with, here’s more on that Pfizer story about use of mobile phone technology etc in clinical trials. It seems to have piqued an interest among many of you anyway.

Also on the subject of clinical trials, I was rather perplexed by this story running out of the NHS Confederation this morning. I’m delighted that the NHS Confederation are at last exercising their PR might in the name of research – it must have something to do with Mike Farrer’s move there as CEO. As you may know, he was previously the chief executive at the North West Strategic Health Authority which led the hallowed ‘NW Exemplar work on clinical trials.

The overall message of the piece about regulation standing in the way of clinical trials is also good. But I am sure the data/evidence they have put forward to support it, passed its sell-by-date a long time ago. If you look at the latest metrics for trials put out by the NIHR Clinical Research Network (CRN) Co-ordinating Centre, one gets an alternative and more up-to-date picture of an improving situation.

Much work is still to be done though.

The really striking bit in yesterday’s MORI survey by the Association of Medical Research Charities (AMRC) was that showing the degree to which patients would be willing to assist in research by participating in trials (72%) or letting researchers access their confidential records (80%). But you have to scroll down the page to see these results.

A bit like we expect patients to ask their GPs to do if they want to turn their willingness to take part in research into action. I am sure I saw an academic paper a few weeks ago which heralded the 39% or equivalent GP practices that were active in recruiting patients for trials in Eastern England. All I could think of was…what about those people living in the catchment areas of the other 61%. Perhaps their GPs still use scrolls instead of prescriptions.

So grist to our mill in making sure the Health and Social Care Bill supports the things that are already being done by NIHR and others to change this.

International clinical trials day and a bit of mopping-up

It is International Clinical Trials Day today and The Cochrane Library has worked with the UK Medical Research Council’s Network of Hubs for Trials Methodology Research to produce a set of new podcasts about clinical trials – well worth a listen.

There was a conference in Vienna this morning organised by the European Clinical Research Infrastructure Network (ECRIN) (Yes, you’ve missed that), and it is perhaps worth reminding everyone that there is an excellent information leaflet and booklet on clinical trials that was produced by the UK Clinical Research Collaboration (UKCRC) some years ago with AMRC’s help.

Some local research centres are also doing special awareness days to highlight their work – for instance, this one in Bath.  And I thought this was a rather nice milestone being reported by the Leeds Cancer Research UK Centre to mark the day – it has recruited 2,000 patients to trials in its first year of operation. 

And if, like me, you intend to hold a roundtable debate with your family this evening about the way forward for the clinical trial you might wish to use this as fodder.

Yesterday while I was at the INVOLVE meeting saying goodbye to its current Chair, Sir Nick Partridge, Mike Rawlins (Chair of the Academy of Medical Science’s Review of Research Regulation), John Bell (President of the Academy) and Mark Walport (Director of the Wellcome Trust) were giving a press briefing on their concerns about the impact of the Health and Social Care Bill.  Mark Walport was on The Today programme this morning

But if you are in danger of going to sleep, have a look at Anaesthesia UK and read the comments made in a speech by Professor Michael Rees, Co-Chair of the BMA’s Medical Academic Staff Committee, about how the NHS reforms are the latest in a long line of recent develops which now threaten to destablise ‘medical academia.’ 

The Today programme reported that the Department of Health had issued a statement saying the Wellcome Trust’s fears were unfounded.  I doubt that very much indeed.  Anyway, we’ll be going at the issue again in a week or so with some added oomph.

Finally, my deepest apologies to Y-Touring for not getting to their special film showing of ‘Mind the Gap.‘  I was mopping-up loose ends and frayed strands.

NHS reforms, research and 'localism'

I really would encourage you to read this morning’s article in The Guardian about the impact of the NHS reforms on doctor  expertise and research.  Its the first article that I’ve seen thus far which really conveys the message about health research that AMRC has been trying to put across and on which we anticipate stepping up our activity as the Health and Social Care Bill heads into the Lords.

It also feels like a significant piece because of the intervention of the President of the Royal College of Physicians, Sir Richard Thompson.  This is the profession’s voice as opposed to the ‘union’ voice as articulated by the British Medical Association (BMA).

At our Science Communication Awards on Tuesday night I got into quite an interesting conversation with some of our guests about the possible implications for research of an NHS reform package which is essentially as much about greater ‘localism’ as it is about establishing a regulated market.

One of the perennial concerns that AMRC often has to deal with is that of small local charities raising money for research taking place at their local hospital or by a doctor who perhaps cared for a loved-one.  It is not the raising of funds that is necessarily the problem.  Indeed, it is important that we do not deter such local passion and conviction.  No, it is the fact that such money is being raised and then distributed in a parochial way; that such local charities very rarely use independent external review (peer review) to ensure they are funding the best science.

That is why – knowing also that administering peer review is not easy or without associated costs – we try our hardest to encourage such organisations to buddy-up with other charities that do have such systems in place or find some way of routing funds to research charities while retaining some sort of footprint on it.

Who is to say that in the new NHS, we might not see GP consortia actively encouraging such local charity connections in the name of ‘so-called research’ – superficially beneficial but in the long-term pretty disastrous.

The NHS reforms and patients…and EU research shake-up?

Science fear not.  Those of you disappointed that the EU summit on 4th Feb only got round to the subject of ‘innovation’ at a late hour and to little discussion should take heart from the fact that patients have been used to being at the end of a conference/meeting agenda etc for most of the last century…

But perhaps not today…No doubt you will have noticed that eight charities had a letter published in The Times in what the BBC called the opening of a new front against the NHS reforms as embodied in the Health and Social Care Bill.  They express concern that the reforms will dilute patient involvement in the NHS.  Six of the charities are AMRC members.  The other two include the increasingly impressive umbrella body, National Voices (who also publish a copy of the letter), and the mental health charity, Rethink.

Meanwhile the Secretary of State for Health, Andrew Lansley, has written an article in The Guardian claiming that growing numbers of people are backing his reforms.  Game on as they say.

It is interesting how, in little more than a decade, we have gone from ‘patient choice’ and ideas around a patient-led health service (which served its purpose well in confronting entrenched attitudes) to talk of a health system which is ‘clinician-led.’  Or, more accurately, GP-led.   My members and other charities are right to warn about the degree to which patients are at risk of being distanced from GPs and health services under the plans for GP consortia. 

But back to that EU story.  The EU Commissioner for research, Márie Geoghegan-Quinn, was at the Royal Society yesterday speaking about future plans for EU research including a ‘clean-break’ from the Framework programme and confirming that an EU Chief Scientist Appointment would be made this year.  The green paper setting all this out is published tomorrow although whether Nature’s call for greater clarity is heeded remains to be seen.

Health and social care reforms on trial

What better starting point for today’s blog than the comments of two leading clinicians speaking about the importance of clinical trials to patient outcomes.  First, Dr Duncan Wheatley, a Clinical Oncologist and Lead for Research in the South West Peninsula, who is quoted in a BBC Cornwall story today about medical research at the Royal Cornwall Hospitals Trust as saying:

‘It makes a huge difference. Obviously we can’t guarantee that the new treatment will always be better than the old treatment, but patients who go into the study, even if they get the normal treatment, generally get slightly more intensive care.”

The story talks more specifically about how research has trebled there over the last three years with now over 300 studies underway and over 1400 patients involved.  It looks as though the Trust is in the process of building its research pages but I hope they follow-up the press coverage today with a bit of showcasing on the Trust home page as well.   I believe most of the research there takes place at the Knowledge Spa facility in Truro and that charity involvement occurs across a number of disease areas including MS and arthritis.

The second quote is from a little earlier in the month, this time from Prof David Newby who is NHS Lothian’s R&D Director.  In this Scotsman piece about NHS Lothian’s strategy to increase the number of non-commercial trials by a fifth he says: 

‘That’s why our research and development policies are so important. It provides major benefits for patients in our area.’

And today you may have seen the story about the breast cancer drug that migth be effective against lung cancer (more trials needed) or indeed this one about the £1 million funding being provided by Arthritis Research UK for a clinical trial in Birmingham to improve treatment for those with Sjorgen’s syndrome. 

It is the degree to which health and social reforms enable us to grow such research activity in England that they will be judged by the members of AMRC.  With the Academy’s report and recommendations on research regulation now out there and the results of the NW Exemplar Pilot published today I feel we might be close to having a finely-tuned engine for clincal trials.  

But it is the chassis  around us – namely the NHS and how it is run – that might now fall apart around us in Keystone Cops fashion.

And for those of you who remain unclear why medical research charities remain concerned about the impact of the NHS reforms, I encourage you to cast your eye over the appendix to the response we put in to the Department of Health’s ‘Information Revolution’ consultation two weeks ago. 

This summarises some focus group research (quoted in the Academy’s report) that we did into patient and GP attitudes to clinical research and use of patient data. The basic message coming out of it is that most GPs are simply not set-up to do, nor engaged with, research to the extent one would hope. 

So what’s one to do when presented with reforms that put GPs in the driving seat for how our health service is run? 

I hope that some of my concerns might be allayed by an NIHR seminar I am attending next week on embedding research in the new NHS.  In the meantime the scenario reminds me of a relative who bought a Range Rover with a diesel engine and decided to put a petrol engine in it.  To cut along story short, the vibrations were so bad that the chassis fell off.

Perhaps a clinical trial for how these reforms might best support research would be wise?  But, then again, Andrew Lansley is a man in a hurry.

The Public health white paper – a new school of thought

‘Healthy Lives, Healthy People,’ the White Paper on public health has been published and is available on the Department of Health website.

The news release sets out the Secretary of State’s ‘ladder of intervention’ – from the rather refreshingly titled  ‘do nothing’ up to ‘eliminate choice altogether’ – which sound like the different states of readiness one might find in one of the armed services. 

Public health will have a ring-fenced budget and the money will be straddled across local authorities (who will be the employers of Directors of Public Health) and a  new national organisation ‘Public Health England.’  

Public Health England will set outcome measures for public health and a new health premium will be awarded in areas according to progress made.  Public Health England will also be the repository of best practice and evidence and negotiate the new responsibility deal on public health between different partners including charities and industry.

You get the picture, if anything this is more about how we organise ourselves to deliver better public health than the interventions themselves.

Last night I said my mind would necessarily be focused on what the document says about public health research.  If the NHS white paper is anything to go by, my sense after a quick skim is that the intention is to see research embedded in how the new organisations do things rather than separate from or parallel too.   

But, in my opinion, the white paper also expresses a clear intent to beef-up delivery in public health research and strengthen the evidence-base for public health actions with the setting up of a new NIHR School for Public Health Research.  A new Policy Research Unit on Behaviour and Health will be established within the National Institute for Health Research (NIHR) and Public Health England will be expected to properly resource research into interventions happening outside the NHS.  Finally, it says that NIHR, Public Health England and others will work together to identify research priorities.

All this seems a positive change to the landscape.  I’m off to see which ‘level of intrusion’ I need to implement with my team.

Up a ladder with the public health white paper

If you refuse to walk under, or indeed climb, ladders then this blog is not for you.

The public health white paper is to be launched tomorrow (Tuesday).  There has been much trailing of various proposals that will likely appear in the document – from providing vouchers to school children who walk to school, to a new inclusion board to help improve the public health of marginalised communities and restrictions on cheap alcohol.

The Secretary of State for Health, Andrew Lansley, talked of a ‘ladder of intervention’ when he was interviewed about the white paper at the weekend.  In other words, the regulatory touch will be light and interventions carefully chosen.  Nonetheless it will be intriguing to see the balance the Government has decided to strike between ‘aunty nudge’ and ‘nanny state.’  The last public health white paper was in 2004 and I seem to remember it being greeted with a chorus of disapproval that Government was veering too much towards the latter.  The debate then was dominated by arguments over whether to ban smoking in public places. 

Whether intended or not, the use of the ladder metaphor by Lansley is coincidentally rather interesting given what I think will be the tone and style of tomorrow’s white paper.  Laddering is a methodology used in marketing to identify what attributes in a product appeal to the values of the consumer and attracts them to it.  I suspect that the overriding approach in the white paper will likewise be about identifying methods by which to incentivise rather than compel the right behaviour changes.  Where interventions are proposed they might well be in those areas that seem more black and white to the public – putting cigarettes into plain packgaing for instance.

However, my day job means I will necessarily search to see what the document says, if anything about public health research.  When the UK Clinical Research Collaboration (UKCRC) produced its 2006 Health Research Analysis of the 11 largest public funders in the UK it showed that only 2.5% of spend went on ‘prevention.’  When the Office for Strategic Co-ordination of Health Research (OSCHR) was set up about 18 months or so later one of its three sub-boards was focused on public health (the others were on e-health and translational research).  The public health one took longer to start and I am not clear quite where its work has got too although my understanding is that it has found the going hard.  if you want more on the research picture you might want to have a look at this analysis of public health research across the EU available on the Faculty of Public Health website.

Notwithstanding the work of this body, the need for a strategy on public health research open to scrutiny seems long overdue and it is one where the funding and expertise of medical research charities with their knowledge of patients could play a major role.  So. here’s hoping that the white paper sees public health research climb the ladder rather than snake further downwards in the order of priorities.

Science at the Conservative Party Conference

Two down, one to go.  Here’s science related ‘matter’ at the Conservative Party Conference which starts in Birmingham tomorrow.

Birmingham University was of course the venue for the Science Minister, David Willett’s, first speech after taking office.  I am looking forward to being one of the hosts when he joins us for a roundtable breakfast on Wednesday.  I have been speculating whether he eats ‘clusters’ for breakfast or plain old corn flakes person.

In terms of the formal conference agenda items of interest include debates on ‘Big Society and People Power’ (cue a reminder to sign the Science is Vital peititon which has over 10,000 signatures now including support from the Wellcome Trust) on Sunday afternoon, ‘The Economy’ on Monday morning before lunch, debates on publci services and welfare onTuesday and the Prime Minister and Conservative Party leader, David Cameron, speaks on Wednesday afternoon.  You can see the agenda here.

My pick on the fringe….I shall be chairing the ‘Innovation as a cure’ meeting organised by Alzheimer’s Research Trust, Anthony Nolan and ABHI on Sunday evening at 5.45 or there is the Breakthrough Breast Cancer tea party starting at 5.30pm if you prefer, and another of our charities, Ovarian Cancer Action is looking at women’s health at 9.30.  The latter features Sarah Wollaston MP who is on the Health Select Committee and a GP.

You can kick off your Monday at 8am with Birmingham Science City which has a fringe entitled ‘Innovation and the Green Revolution.’  A bit later at 12.30pm why not decompress after George Osborne MP’s speech to conference by going to the British Chambers of Commerce debate.  I only mention it because the Financial Secretary, Stephen Timms MP, and Shadow Business Minister, Will-Butler-Adams MP, will be speaking.  Surely after hearing from this trio we might be able piece together a narrative for economic growth?

But I am sure most of you would prefer to hear David Willetts speak at the NESTA fringe which is taking place at the same time (12.30pm) on the subject of ‘Made in Britain: Building a 21st century economy.’  Either that or hearing Earl Howe, the Department of Health Minister responsible for medical and health research, speak at the ‘Research to the rescue’ fringe at 12.45pm hosted by BHF, Diabetes UK and the Stroke Association.

The Guardian’s engaging Michael White chairs the Health Hotel debate on Monday evening (19.30) and Health Secretary Andrew Lansley MP is speaking at the Health Hotel reception afterwards (which is invitation only sadly, what happened to the days when you could walk in to these things).

The 1994 Group and others hold a lunchtime debate on the future of higher education at 12.30pm on Tuesday and so are Reform with Universities UK at 1.00pm with David Willetts MP invited.  This one is called ‘Building the Future: Higher education and economic growth.’  [nb: one of the perils of conferences is the fact that many similarly-themed fringe meetings clash but I find you can run from one to the other if you are quick on your feet).

Also of interest on Tuesday lunchtime is the Asthma UK, Novartis Pharmaceuticals UK Ltd and Smith Institute fringe: ‘Can Health Cuts Be Good For You?’ Andrew Lansley is down to speak at this one which starts at 1.00pm. 

The Royal Society takes its ‘Scientific Century’ debate to conference on Tuesday evening at 7.30pm with David Willetts MP, Paul Wellings (Chair of the 1994 Group) and Brian Cox.  The Chemical Industries Association pop up this week with their own event at 7.45pm looking at ‘Science Education: The next deficit’ which looks more like a reception but I might be wrong.

And that’s it….a much busier conference than the other two as you might expect.  I look forward to seeing you there.