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The Medical Research Council (MRC) is ‘a good egg’ and that’s the issue

Science historian and Guardian science blogger, Vanessa Heggie (@HPS_Vanessa) has written a fascinating piece about how AIDS activists among others changed the way we run clinical trials and persuaded researchers to adopt new methods.

That’s certainly the history lesson passed down to me as Chair of INVOLVE by previous members.  They will tell you that, before we ever talked about definitions, standards, impact or, rather bizarrely ‘what is a patient?’ it was protest and a sense of injustice that drove patients to clamour for change and hammer on closed doors.  They will also tell you that our very own Medical Research Council (MRC) was one of the organisations with doors firmly closed and drawbridge raised.

This year, the MRC has been celebrating its 100th birthday.  Like every centenarian it will have got a telegram from the Queen saying:

“I am so pleased to know that you are celebrating your one hundredth birthday this year.  I send my congratulations and best wishes to you on such a special occasion.”

If I were President I would add a ‘PS:’  But you need to do more public involvement if you want another telegram plus some birthday money next time.

The MRC is a curious organisation when it comes to public involvement.  I am in touch with a great many MRC  colleagues whose commitment to it is palpable.  As I go around the country, patient and public friends are often fulsome in their praise of MRC trials, how they have been run and how they were treated as participants.  In October, the MRC Clinical Trials Unit, – a world-class centre of research excellence – held a workshop to discuss how to strengthen public involvement in clinical trials in the future.  It is important that we support and encourage such activities in order for them to grow.

But, step closer to its HQ, and things become that bit more hazy.  In fact, befuddlement might be the best word to describe its corporate response.  Imagine people coughing and shuffling papers on their desk when asked a difficult question and you have it about right.  Fact is, they just don’t get public involvement or perhaps even ‘the public.’

The disjointedness between this corporate persona and its more streetwise operational self hit home to me when I viewed their new 2014-2019 strategy ‘Research changes lives.’

This document was published last week. The second of its strategic aims is entitled ‘Research to people’ and this has three objectives including one on ‘Engagement: To enhance engagement and communication with our scientists and partners, policy-makers and parliamentarians, and the public.’  What that means to the cynical part of me is that the MRC remains wedded to the notion of talking ‘to,’ if not ‘at,’ the public rather than taking a more courageous step to involve them in its decision-making.

The MRC has struggled with the notion that people who are not scientists might have something useful to contribute for as long as I care to remember.  When I became chief executive at the Association of Medical Research Charities (AMRC) and met its then chief executive, Professor Colin Blakemore, it was clear that engagement was the thing.  That meant raising public awareness and understanding.  No more, and no less. Professor Blakemore did awareness raising – and does it – very well indeed and he should be applauded for it.  It has never really moved from this position since.

I did experience a glimmer of hope some time ago when it was going through a revamp of its committees.  But, alas, I was to be disappointed.  Its Ethics, regulation and public involvement committee contains many ‘good eggs’ who I admire greatly. But they do not constitute a patient and public forum who could inform and shape the MRC’s decisions and work based upon people’s lived experience of research – whether as participants or interested members of the public.

The thing is, like many old institutions with cultures stronger than their constitutions, the MRC is a good egg that simply likes its ‘good eggs.’  It is attracted to status and titles.  And that means neither you nor I, I suspect.  So while its doors may be ajar compared to two decades ago, they are also wooden and heavy and cumbersome.  That means they are likely to spring back and do you and I an injury at any moment.

That’s a shame because it overshadows the excellent public involvement work being hatched ‘out there’ by MRC staff in their respective field.  They’re the ‘good eggs’ in my book.

Blog: We have the public to thank for this week’s well-informed decisions in health research

We have had two pieces of good news about health research of patient benefit this week.

First, the National Institute for Health and Care Excellence (NICE) issued new guidance saying that tamoxifen or raloxifene taken daily for five years can cut breast cancer risk by 40%.  This means women at risk of developing breast cancer have a choice other than mastectomy. There is a good BBC news piece here if you are interested.

Then, this morning, the Chief Medical Officer Professor Dame Sally Davies told BBC 4′ s ‘Today’ programme that the government will be putting new regulations in front of parliament later this year that would give the go-ahead for what is called ‘three-person IVF’ to enable children to be born without genetically inherited mitochondrial disease.  Parliament is to be given a free vote when the legislation comes before it.  Ian Semple’s article in The Guardian today is a good summary.

Both are extremely important announcements.  Each has been accompanied by debate in our media about the pros and cons.  I am sure this will continue.  But more significant are the decisions these will enable families to take where, in the past, there has been little if no choice.  I can only imagine the sense of empowerment that brings.  However, we must be sure that people have the full facts and information in front of them when considering their options. Whatever their decision, they must also feel that their choice and the reasons underpinning it are respected by professionals, colleagues and friends.

In my opinion these feel like well-informed announcements from a patient perspective, developments that the public should have confidence in.

Quite apart from the fact that NICE’s decision is based on evidence from large-scale clinical trials involving thousands of women, you may wish to have a look on their web pages at how they reached their decision.  As with all its guidelines there was an extensive period of evidence gathering and consultation.  And it is worth mentioning that the Clinical Guidelines Group (CDG) that took looked in detail at this included three patients/carers among its membership.

In terms of the ‘three-person IVF’ move, this has been pre-dated by months of debate including an extensive public dialogue exercise run by the relevant regulator, the Human Fertilisation and Embryo Authority (HFEA).  You can see the results of this exercise led by Sciencewise and also the recommendations made by HFEA to the Department of Health here.  No, it didn’t say that everyone supported the idea.  But in what I thought was a very well framed document, it said that the overwhelming opinion to emerge understood the benefits from a societal and patient perspective.  And on this basis that such procedures could and should be licensed.

Seems to me that when asked, and given time, the public are rather good on this issue at blowing away the smoke that others are keen to blow into our eyes.

 

It’s NIHR Friday – Public involvement: did the research network move for you?

NIHR Clinical Research Network Survey

Patient and Carer (Lay) Involvement in Research: Your Experience

The National Institute of Health Research (NIHR) Clinical Research Network (CRN) Patient and Public Involvement Steering Group is running a survey to capture how being involved in research impacts on patients and carers.

You should take part in this survey if you are a patient or carer (lay person) who is involved as a research partner or collaborator at one of the Clinical Research Networks.

We will produce a report summarising the findings from this survey.  We will use the information that you provide to encourage more people to get involved in research and to improve the experience for all individuals.  We will not be identifying individuals by name in the report.

If you are interested in taking part, we would like to hear your views.  Please click here to complete the online survey:

The deadline for completing this survey is Friday 26 July 2013.

 

Now this is good, very good. The Cystic Fibrosis Trust has a transparent new research strategy

The Cystic Fibrosis (CF) Trust launched its new five-year research strategy in London yesterday.  I have to say I am highly impressed.  In terms of content and dissemination they seem to have single-handedly shown the rest of the medical research charity sector how to embrace the future as a funder and a patient group.

Why is it so good?  Well, the research strategy is clear and visionary.  It seems to strike the right balance between basic research and clinical research.  But it’s more than that for me.  Most important is the firm commitment to ‘Enhancing the involvement of people with cystic fibrosis in shaping research’  as one of its three enabling piorities.  I also like their very simple but effective ‘SCORE’  approach to evaluating potential research ideas to fund. It’s about time more charities came out with similar focus and simple creativity.

I’m also pleased that CF Trust’s new approach to research is available to a wider audience using Cystic Fibrosis Unite among other devices. As I found out after I did the first (perhaps exciteable!) version of this blog CFUnite is independent of the CF Trust and funded by a Wellcome Trust People Award. But my excitement is not totally unfounded.

I love the fact that CF Unite embraces and pulls in all possible partners in making research happen – you really do want to be part of the enterprise.  On the CFUnite site you can register your interest to help design and take part in clinical studies.  And you can email them if you want to find out the results of relevant trials.  This is just the sort of thing we should be doing in the name of transparency and in the public interest.  You can find all these features here.

CF Trust complements this with its own cross-referencing and linking to CF Unite but also by giving people information on clinical trials taking place in the UK.  This is a facility that it has made available for some time and shows its long-term commitment to making sure this sort of information is in the public domain.

Its a worthy package that has made my day.

Political spotlight on Health Research Authority (HRA) intensifies

I am sure the new Health Research Authority (HRA) can take care of itself.  But the expectations being heaped on it by others show no signs of abating. I wouldn’t be surprised if tomorrow someone calls on it to cure cancer. If it had been created by a Blair Government it would surely have been dubbed ‘The People’s Health Research Authority.’ Come to think of it…..

Why do I say this?  Well, the committee of MPs and Peers looking at the draft Care and Support Bill establishing the HRA has just published its report; the Association of Medical Research Charities (AMRC) has provided an excellent overview of their conclusions here .

The key message from the committee is that the HRA should be ‘promoting’ research.  I am sure this is right. But the very real problem for the HRA is how do you define this in practice?  For the answer is potentially as long as a piece of string.  There is certainly a real danger for mission drift if it’s not careful. There is also some irony in the fact that it was onlya few short weeks ago that three eminent Peers wrote to The Times criticising the HRA and other regulators for the amount of money spent on media and communications. Damned if you do, damned if you don’t (see my blog on this from just a few weeks ago).

Did anyone else also raise an eyebrow at the conclusion parliamentarians drew that there is ‘no single body promoting health and social care research?’ Er, the National Institute for Health Research (NIHR) perhaps? For one.  It feels that the Committee has assumed the body language of funders and researchers when it comes to this thing called ‘promotion:’  quite simply they are good at promoting their own science but when it comes to promoting science in general it is rapidly becomes someone else’s responsibility. And often the responsibility of organisations that are already running on vapour in terms of resources.

Yet it is evident from the conversations I have had with colleagues thus far that generally they have been encouraged by the quietly efficient and logical way that the HRA is going about its business.  It’s approach to public involvement seems sensible given the lack of precedence for where it wants to head.  Its stakeholder event a few weeks ago was, by all accounts, excellent.  It is steaming ahead with its pilot of speeding up approvals.  These are all good things and it is important that we support their endeavour in the coming weeks and months if it is to become the fair but robust regulator we all wish to see.

Across the Committee corridor the House of Commons Science and Technology Select Committee has just  published all the written submissions it has received as part of its inquiry into clinical trials.  Some of these submissions are filtering into the press.  And this evening I noticed this piece from Outsourcing Pharma.Com about the evidence of the Clinical Contract Research Association (CCRA).  It again puts the onus on the HRA pulling things together. (By the way, I was just as interested in CCRA’s call  to simplify consent and other complex processes which stand in the way of patients taking part  in trials).

As it takes oral evidence, Committee  members will focus in even greater forensic detail on the role of the HRA in promoting transparency in the registering and reporting of clinical trials.  The Care and Support Bill Committee took a strong line on this and says HRA must lead the way.  I would agree 100% with them.  But HRA can only do this if it has strong political backing from the beginning and when it is having to face down the recalcitrant funder or researcher who won’t play ball.  All on the basis that it is just ‘red tape’ preventing them from doing their life-saving work.  For it is at those moments that the wind is often taken out of the regulator’s sails by a lack of courage of the part of our politicians.

So how the Committee chooses to deal with this particular issue is going to have an important bearing on the future workload of the HRA and how it is monitored in parliament.  In the meantime, the Care and Support Bill will establish its formal role.

Yep. There’s no doubt about it. All eyes are on the HRA and this is just the beginning….

Comment: The Sherpa’s story and its relevance to public involvement in health research

I am indebted to a good friend and colleague of mine who, some time ago, sent me this BBC News story from last year.  It reports on the rising concerns among Himalayan Sherpas about the lack of regard being shown towards their needs and the environment as scientists tromp all over the local geography.  To the extent that they are threatening to withdraw their labour.

I used it last week for an NIHR talk.  I read out extracts to the assembled post-lunch audience (yes, I care that much about my audience that I don’t like to work them too hard after lunch).  Before I did so, I asked them to substitute every mention of Sherpa with ‘patient’ and every mention of a geographical place with ‘health research’ or ‘NHS.’

I invite you to do the same…It sort of works.  Then ask yourself what would happen if we allowed the same behaviour in health research and what the outcome would be if patients and the public withdrew their labour?  Well, of course, this behaviour does happen all the time and it’s something of a wonder to me that patients don’t object more often.  They should do…and loudly.

Anyway, I like the story and thought I would share it more widely on the blog.  It’s just a different way of getting the message across that public involvement should be a core principle of any health research organisation – funders, journals, Government, universities* blah blah.  For it’s easier to get to the top of ‘Mount Everest’ if patients and researchers work in partnership.  We are also more likely to climb the mountain that matters to ourselves and our fellow human beings if it becomes a joint endeavour.

I mean sometimes I listen to researchers on the radio talking from the top of the mountain they have just climbed and think…what the heck are you looking at from up there?  For what did you climb that tor?  Put your crampons on and get your rope.  I think you’ll Fiennes that the action is over here.

Brief sermon from the mount is now over.  Parting of the oceans will come later when I head into town.

* By the way if you every want a true indicator of how financially troubled our universities are, next time you visit one: count the number of cranes and then count the number of empty rooms, labs etc.  Then do the same every time you go back.  Interesting.

Public have their say on clinical trials gateway

This is already doing the rounds on twitter but I thought I would share the email/letter that I have sent out to those who took part in the survey….

I am pleased to let you know that the results of the UK Clinical Trials Gateway (UKCTG) Patient and Public Survey conducted last summer have been published today by the National Institute for Health Research (NIHR). You can read the full report on the NIHR home page here:http://www.nihr.ac.uk/Pages/default.aspx .

Over 600 people took part in the on-line survey and it is clear from their response that UKCTG is seen as a welcome and important initiative. The challenge is to ensure that UKCTG meets its full potential from a patient perspective in the coming months and years. The main findings from the survey are as follows:

• 83% of respondents identified themselves as a patient or carer.
• 80% had not heard of the UK Clinical Trials Gateway (UKCTG) before receiving the survey.
• Only 28% had taken part in a clinical trial.
• 38% said they knew little or nothing about clinical trials and would like a clear and
reliable source of information to learn more; 56% said it would help them or someone
they care for explore opportunities to take part in a clinical trial now or in the future.
• 64% said they would like to find out about trials recruiting in their local area.
• 66% said they found UKCTG ‘easy’ or ‘very easy’ to find their way around the site, 28% rated it as only ‘satisfactory’.
• 67% said they found the information provided on the site ‘very clear’ or ‘fairly clear’. • 72% said that UKCTG should help them make direct contact with a clinical trial without going through their doctor.
• 88% of patients said the site should provide people with relevant links to patient
groups, medical researchers and funders, which are relevant to a clinical trial study. • 88% said they would recommend the site to others.

The report of the survey includes recommendations to UKCTG on how it should be developed to better reflect the priorities of people interested in finding out about, and taking part in, clinical trials. Recommendations are made in the following areas: Vision and Strategy; Awareness and Promotion; Facilitation and Recruitment; Content and Ease-of-use; Access and Marketing and; Public Involvement/User Panel. In my introduction to these I talk about the need for UKCTG to adopt an operating philosophy which is much closer to the growing appetite and expectations of patients when it comes to research:

“Inherent in the survey findings is a challenge to the UKCTG to align itself ever more closely with the priorities and needs of patients looking for research opportunities. At the core of this is a desire to see the UKCTG evolve its current model as a simple ‘information provider’ to that of a more interactive patient partner, which helps supports their choice to participate in a trial or not.”

This opens up many exciting possibilities and I am looking forward to working with you in supporting UKCTG to develop a a bold vision and direction for the future. A key element in this process will be the new ‘User Panel’ and your thoughts on the most effective way to establish this which captures and maintains people’s enthusiasm are most welcome. In the meantime I would urge you to continue to promote the site and the downloadable ‘app’ through your networks and in your conversations with patients, members of the public and research colleagues.

My thanks again for taking part in the survey. I shall be writing again in due course to those of you who expressed an interest in joining the UKCTG User Panel.

….more on this tomorrow.

Help us make sense of the placebo effect…

I am involved in this follow-up study to one published a few months ago (and covered on this blog) about the poor information given to patients about the placebo in clinical trials.  In the first instance the researchers are looking for people to input into the design of a leaflet.  Details and contact email follows:

Have you ever taken part in research before?  Would you like to help improve the way research is communicated to patients?  Researchers at the University of Southampton are writing a new leaflet to explain placebo-controlled trials to patients and would like some volunteers to help.
We are looking for 10-20 people who have taken part in a clinical trial or other medical research.  We will send you a copy of our leaflet and you can either write to us with your comments, email us, or talk to us over the phone.  The leaflet is only one-page long, so we do not anticipate it will take you too long to tell us what you think about it.  For more information or to volunteer, contact Dr Felicity Bishop on F.L.Bishop@southampton.ac.uk

Royal College looks to boost child health research with children’s charter

I am prone to beating up our Royal Colleges for one reason or another.  But, over the last few years, I have grown to admire and respect the work of one of their number in particular – the Royal College of Paediatrics and Child Health (RCPCH).

Yesterday, RCPCH launched a new report entitled ‘Turning the Tide: Harnessing the Power of Child Health Research’ which is part progress report and part agenda for change.  The College’s campaign will aim to:

  • Debunk the myths surrounding clinical trials – and push for the introduction of a system of ‘opting out’ of  studies designed to reduce uncertainties in treatments, rather than ‘opting in’
  • Bring organisations together in a UK “Children’s Research Collaboration” to optimise use of funding for research and raise awareness of the need to strengthen children’s involvement
  • Improve education, research training, and guidance for paediatricians: with the RCPCH pledging to improve research training for all paediatricians  and clear routes into research careers
  • Strengthen the infrastructure for children’s biomedical research in the UK by supporting the establishment of a children’s trials network for non-medicines as well as medicines studies, and children’s health sciences networks to share resources, and promote cross-institutional collaboration between paediatricians, adult physicians, and non-clinical scientists researching the early life origins of adult diseases

There’s a very powerful section in the report about what the NHS should be doing which you could read across many, if not all, other conditions.

Two additional comments.  The idea of a UK Children’s Research Collaboration (UKCRC! funnily enough - see yesterday’s blog) is a good one.  Quite apart from the greater co-ordination of efforts that would result, precedent suggests it will also help amplify the message (one of the points Richard Smith noted in his BMJ blog today about charities needing to work together more).  The arguments in favour are given further force this afternoon by the news that donations to medical research charities are now falling (see AMRC blog).  Quite simply it is about efficiencies of scale.

I’m also delighted that RCPCH and its partners are going ahead with the idea of a ‘children’s charter.’  The College seem to have developed a strong public involvement model of working and I went to one of their meetings with young people and parents a few months ago as part of the ‘Turning the Tide’ preparation work.  This was an idea that came out of that meeting and I am pleased it has gained credence with the report authors including Neena Modi, Vice-President at the College.  In setting out children’s rights and expectations when it comes to research I am sure we would all wish to support and applaud its development.

Cancer Research UK to get a new look

I noticed this in Civil Society from a few hours ago.  Cancer Research UK (CRUK) – the largest publicly funded medical research charity in the UK – is reported to be launching a new identity in September to coincide with the 10th anniversary of its establishment from the merger of Cancer Research Campaign and the Imperial Cancer Research Fund.  The article includes an extensive interview with CRUK’s director of marketing and fundraising, Richard Taylor, as well as a sneak preview of the new logo.  Rather like the change and the thinking behind it I must say.

Is it an industry or a movement we are creating?

In his Guardian blog yesterday, Dick Vinegar, asks a genuinely good question:  ‘Who is fighting the patient’s corner?’

He writes about his recent attendance at a Westminster Health Forum conference about Healthwatch, and voices concern that all we are doing is creating just another bureaucracy in the name of patients.  A thick, muddy, layer of ineffectiveness which will be, at best, no worse than the previous one.  Funny how, in the face of it, we have become all dewy-eyed at the distant memory of the much-maligned Community Health Councils (CHCs).

Anyway, it sounds like one of those conferences I was pleased I missed in the end even though I was booked to attend.  Not least because I didn’t then have to listen to Stephen Bubb’s new-found ‘expertise,’ as reported by Dick Vinegar, on who funds the most medical research in the UK.  Quite alarming.

Watching the daily traffic on twitter from this conference or that conference, much of it laden in the latest buzzwords, I sometimes wonder whether we are indeed living in a parallel universe to the public.  In fact I suspect Dick speaks for most of the nation when, with refreshing honesty, he admits his lack of knowledge about some of the ancestors of Healthwatch.  I guess that even those that can, would then have difficulty describing what they do or what they have done.  The portents are not good for the latest round either.

On the other hand it is easy to overlook the impact that patient advocacy has had in recent decades and rather opportunely I noticed that PatientView have brought out an interesting report looking at the influence of patient groups in the UK and around the world.  Discuss!

But I do fear that we are at times in danger of creating an industry that reflects the interests of its managers and owners, rather than the social movement – a group of people with a common ideology who try together to achieve certain general goals – that I hear many people aspire too.  Form and function have taken precedence over aim and purpose.  What is missing it seems to me is a complete lack of thought about how, looking beyond the new structures, we ‘get out there’ and mobilise public interest and participation.  Hence many good colleagues will find their way to the table to find that their feelings of isolation are not much different to the ones they had in the old world. They will plough a lonely furrow and the yields will be poorer for it.

Last week I had the good fortune to share some time with two colleagues who have both been around a bit and know their stuff on public involvement.  I was expressing my worries about how obsessed people are currently about structures, definitions and processes.  We work long and hard to create these things and then wonder why the public pass it by.  I asked whether this had always been the case – particularly with regard to public involvement in research – and whether people had been paralysed with an overriding need to cross all the t’s and dot all the i’s .  The answer was refeshing:  ‘No, we just got in there.’  Anywhere, in fact.  The philosophy being to seize on any opportunity that could help make change happen.  And it did.

‘Get out there, get in there’ sounds like a perfectly reasonable call to action to me.

 

 

There is no point to the javelin

It has come to this.  The world’s top tennis players rush their shots to beat an 11pm curfew.  Bruce and Sir Paul are turned-off mid-performance.  And they don’t use real javelins in schools.

Looking across the the athletics field at my sons’ school sports day, I spied a clutch of children competing in the javelin.  Except this is not a javelin as I remember it.  It’s more like one of those foam beach toys.  But nowehere near as good.  In fact it’s probably more like throwing a giant, over-ripe banana.  I admire the optimism of a small boy as he lets fly.  I imagine his disappointment as it is carried sideways by the wind and belly-flops to the ground.  There is no point to the javelin I mused.

UK scientists who have long complained about the blunt and risk-averse nature of the current EU Clinical Trials Directive, will no doubt be pleased by the Commission’s announcement today to bring in a sharper legislative instrument.  The new ‘Regulation’ will mean lighter touch regulation for ‘low-risk’ clinical trials and a streamlining of the regulatory process across the EU.  This, married with the EU’s recent enthusiasm for making trial data publicly available, also looks like good news from a patient perspective. Nature coverage here.

Whether it stacks-up against the five ‘wishes’ that the European Patients Forum (EPF) expressed during the consultation about the existing Directive remains to be seen.  The Forum hoped that any revision of EU law would result in:

1. Ensuring meaningful patients’ involvement across all aspects of clinical trials;

2. Giving patients access to quality information regarding clinical trials;

3. Meaningful informed consent;

4. Transparency concerning the results of clinical trials;

5. Access to treatments after the end of clinical trials.

Faster, quicker, leaner trials, yes.  Rules that reflect patient choice, voice and experience, I fear not.

The Commission’s own web pages have a stack of information available about the new Regulation including a ‘Citizen Summary.’ That all other documents constantly refer to research ‘subjects’ betrays the fact that the full extent of the patient agenda is not quite part of their core philosophy.  Indeed. the summary is just that, it doesn’t really convince in explaining how citizen rights and interests have been reflected in the proposals.

When is science, or more particularly medical research, going to wake-up to the fact that the effectiveness of modern regulation and modern regulators hinges on a partnership between those being regulated and their consumers?  Perhaps closer to home we might have greater cause for optimism.  The new Health Research Authority (HRA) has just had its second public involvement workshop and is working through the options of what might be tangible outcomes of this work as part of its business plan.

Back in Brussels, I hate to say it, but it still feels like we are being given foam arrows.  And with none of the fun of the beach.

Enjoy your summer holidays.

The NHS Commissioning Board Draft Mandate and patients in health research

The Shard went up (officially).  And the NHS Commissioning Board Draft Mandate came down from on high.  All on the same day.  Add the odd torrential downpour with its associated misery and these could be Biblical times.

I have come to the conclusion that it is my fate to be locked away somewhere remote and with an intermittent phone signal when such momentous events occur.  On this occasion I was taking part in the Third NIHR Experimental Medicine Research Training Camp; a three-day residential meeting where over 60 NIHR doctoral students were learning the art of science communication.  By their own confession they were taken out of their comfort zone.  No more so than when they had to test their ideas in front of our excellent lay advisory panel.  It forced them to think differently, to re-interpret their knowledge and expertise from a public and patient viewpoint.  But the outcome in terms of their plans and ideas was superlative.

So what about the NHS Commissioning Board Draft Mandate from the point of view of public and patient involvement in research?

Unsurprisingly most attention has been drawn to page 26 of the Mandate headed’Promoting growth, research and innovation’ which looks at the role of the Board in promoting research by:

  • Working with research funders
  • Improving adoption and spread of new technologies
  • supporting patient participation in research

Objective 17 and associated Annex B set out more precisely how this will be achieved and measured.  The commitment to measure increasing patient recruitment is important.  It is my view that this data should not only be about participation rates (already available through the clinical research networks), but also the extent to which patients are being offered the opportunity to take part in research  (a possible role for the Care Quality Commission (CQC) through its annual patient survey).  Together, these measures would tell us much about the extent to which the NHS is realising its duties in terms of research and patient choice.

For what it is worth, my own view is that the real game-changer in the Mandate when it comes to participation, falls within the ‘Choice Framework’ set out in Annex D.  For this begins to set – for the first time and in some detail – the expectation that patients should be offered the opportunity to take part in relelvant and appropriate research as part of their care and treatment.  It gives them and us license to challenge the system to make that choice a reality.  As will the reviewed and renewed NHS Constitution when it comes out in draft form this autumn.  Or I hope it will anyway!

The less satisfying aspect of the Mandate is the weakness of its statements on public involvement – as National Voices has already pointed out.    In fact, it is very poor indeed.  I already have a growing sense of unease over the new corporacy which may be creeping over some Clinical Commissioning Groups (CCGs) as they tackle the issue of public involvement.  A number of CCGs are clearly in the search for those with specialist expertise and skills, as opposed to finding those who can reflect and articulate the patient voice.  Others, on the other hand, are doing their best to get it right.  But it is difficult to get a cohesive picture of what is happening because the signals are intermittent and often broken-up.

So I would say this.  It is important that we respond to the consultation on the Mandate to support and strengthen its statements about patient choice and research.  But equally important is to hear people’s experiences about what is happening with public involvement locally, good and bad.  For we must make the case that, in order to meet its objectives, the NHS Commissioning Board has to ensure a better foundation for public involvement than it has thus far.

Only if we provide space for patients to challenge the system will we see improvements in the way that care and treatment is provided and people’s choices honoured.

New science networks herald more fertile ground for health innovation

If contemplating NHS change rest assured, and this from one who once visited Mt Etna, that the lava does solidify, some old structures do survive, and it is possible for new ones to be built with solid foundations.

Herewith some new and some not so new ‘kids’ on the block in the world of research.

First, great to see that my good colleague and patient advocate, Derek Stewart, has started his own blog and has got off to a predictably brilliant and incisive start with a piece entitled: ‘What I want from research.’   I’ve also listed his site on my blog roll (see below).

The British Heart Foundation (BHF) has a new report out today entitled ‘Clear and Present Data.’   It examines how use of patient data is integral to medical research.  There’s a youtube video available through the above link and BHF have also published the results of a YouGov survey of public opinion on patient data issues.  Suffice to say that this is all part of a significant push by the medical research charity sector on patient data issues – it is, for instance the theme of AMRC’s parliamentary summer reception on 12th July.

The BHF report makes six recommendations including introducing an opt-out system for use of anonymised data in research (already a Government proposal subject to the outcome of a public consultation later this year), and changing the remit of Caldicott Guardians.  Not sure about the last one – I would need to think it through from a patient perspective in the context of a ‘localised’ NHS.   But good to open the debate.  For the results of the survey and an overview it might be easiest to read the guest spot on the Association of Medical Research Charities (AMRC) blog by Joe Clift from BHF. 

A number of BHF’s recommendations are focused on the HRA, so a brief ‘congratulations’ to the excellent Janet Wisely who was recently appointed Chief Executive there and has really taken up the public involvement challenge.

Finally, the entirely new kids on the block are AHSN’s or Academic Health Science Networks.

The Department of Health published a guidance document about their formation on Friday, and potential networks have been asked to submit ‘expressions of interest.’  AHSNs really do represent a significant and positive enhancement in terms of where research meets the NHS.  It is not so much what they are as an entity as what they will bring together in terms of local NHS organisations, academia, industry, providers etc behind a common purpose.  It is also the comprehensiveness of their remit given that they will not just be responsible for the diffusion of innovation but also the promotion of research including trials and public participation.  I suspect more change will ripple outwards.  The Governance arrangements will, however, need to be strengthened with strong public involvement mechanisms.

Perhaps AHSN’s represent new lava flows in research bringing more fertile grounds for growth with them.

 

 

DH and charities reach acoRD over medical research costs

Divvying up the costs of conducting research in the NHS funded by medical research charities is an intricate business.   Who pays for that research nurse, their time in administering the extra treatment required in a clinical trial, the procedures and equipment needed as part of its conduct, the oversight and governance needed to ensure that things are done properly and with patient care uppermost in mind? When do these costs begin and end?

For both the NHS and charities the concern is to be able to demonstrate appropriate use of respective taxpayer or donor funds, for the purpose for which it has been intended; to have a system for the apportionment of costs which recognises the value and contribution of both partners to making trials happen and does not inadvertently disincentivise either because of perceived unfairness.

It is an issue which has been tussled over for a considerable period of time with the latest discussions dating back to well before I left the Association of Medical Research Charities (AMRC).

Happily the Department of Health and AMRC have now reached agreement and the final document – entitled AcoRD for short – can be found on the Department’s website.  The document – which came out late on Friday – takes a principle-based approach and includes case studies to guide decision-makers.

It is an important document.  Consistent and coherent implementation overseen by both will be crucial.  The linkage of the application of the rules so firmly to those charities who have AMRC membership, is an important amplification of the status AMRC now holds in ensuring quality and excellence in the sector.

Have charities really put the brakes on public involvement in research?

I was pulled-over by the police on the M25 on Sunday night.  Unbeknown to me, my car brake lights had failed so that they were permanently on.  Quite apart from blinding any traffic on my tail, an unwitting driver could easily have mis-read my intentions with who knows what consequences.  Thankfully that didn’t happen.  And by the way, thanks to the AA man who repaired them.

A few weeks ago, the Association of Medical Research Charities (AMRC) published an excellent report of the five-year audit they have done of the Association’s 125 members and their peer review practices.  You can download it from their website here. It shows that UK medical research charities are as committed as ever to independent external review of their science.  And it is this sector-wide commitment to peer review – to almost the exclusion of all other factors – which locks them into the prevailing consensus on the pursuit of science in the UK.  For better of for worse.

But there is a statistic in the report that troubles.  This shows that the number of charities that use lay people in peer review (49%) is very similar in 2011/12 to that (53%) of the previous previous audit completed in 2006/7.  Have charities really become static on public involvement or am I just not seeing through the static?

Now, we have to be a bit careful here because I know from colleagues that the story behind the numbers today is quite different to what it was then.  Five years ago charities tended to simply stick lay people on panels, count this as involvement and forget about them.  Nowadays – as AMRC’s report and other documents it has produced shows – the role and contribution of lay people is better facilitated and richer as a result, from separate panels feeding into peer review, to developing research strategy not to mention contributing to research dissemination.  AMRC’s science communication awards also bear witness to this.

But I am not going to let my beloved sector off the hook completely: there are other indicators that paint charities in a disappointing light when it comes to public involvement.  For, even with the silver lining portrayed above, the figures in successive AMRC peer review audits indicate that around half of medical research charities do not involve the public in the way they decide how to apportion donor or supporter money to research.  Go figure.

The recent INVOLVE/National Research Ethics Service (NRES) report on public involvement in grant applications also showed that, of those funded by charities, about one third included no public involvement and about another third had ‘ticked’ various public involvement activities as part of their study but were unable to confirm what this was in free text.  In my view charities should be at the top of the leader board, way ahead of the current front-runner in the INVOLVE/NRES study which is the National Institute for Health Research (NIHR).

I also know from my work with NIHR’s clinical research networks – and local research networks in particular – that charities are certainly ready and eager to fund clinical trials or studies.  But they can be less engaged in the equally vital task of securing patient and public involvement in trials, and in recruiting patients when trials open.

This whole area deserves deeper inquiry to find out what the true story is.  But my hunch is that a core of  charities, enlightened about their relationship with their public, have simply got even better at the task of involvement.  Too many, however, continue to tiptoe nervously around the subject.  Others just refuse to play ball for one uncharitable reason or another.  This does science and the public a disservice.

With ever greater scrutiny of their role in society, charities must constantly demonstrate and not just advertise their unique ‘copyright’ over public support for research in this country.  By involving their beneficiaries they can perform an important pseudo-regulatory role in ensuring that the way in which science is conducted – as well as what it chooses to focus on – ‘protects and promotes the public interest.’  Their supporters prove time and time again to be the best at getting the message across to fellow patients, clinicans and researchers.  But most of all public involvement is a fundamental part of the charity genome: it is the impulse that urges us forward to question, to innovate, to never accept the consensus.

Don’t get me wrong, I think the charity sector is one of our greatest strengths in UK health research.  That doesn’t mean though that on some things I don’t think we can do better, much better.

But perhaps I just can’t see past those faulty brake lights.

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