Medical Research Council

First, the positive.
Why should this matter to you and I? Because this is the second occasion in less than six months when a senior research leader in the UK has been appointed by the public as well as fellow scientists.  The other appointment is Professor Bart Strooper of the new Dementia Research Institute which is to be based at UCL.  By all accounts the interviews with the public have been the most challenging part of the process for candidates.  World-class public involvement in action!
I am feeling less positive about the new Life Sciences Strategy which is due to be published as part of the Government’s industrial strategy (by all accounts, at the end of April).
I mean, who knows what’s happening with it? The stock response I get from most people when asked is ‘I wish I knew.’ Or similar.  Which suggests things are not as open, transparent and inclusive as when the previous Life Sciences Strategy was written in 2011. Either that or my memory of those days is failing me. Or, more likely, I’m simply outside the ‘circle of trust’ convened by the Government’s chosen author for the strategy, Sir John Bell.
By most accounts – and notwithstanding the occasional workshop – I hear that it’s a strategy being written by the life sciences industry for the life sciences industry. Which suggests a conclusion not unlike the Accelerated Access Review published before Christmas (and which has been subsumed within the Life Sciences Strategy process I believe). A review where the patient voice was swept aside from the main report in a rather nonchivalrous manner.
So, the first issue I have is with the way in which it is possibly being done. The second issue is whether we will see the link with patients strengthened as it should be.
What was good about the 2011 Strategy is the way that it was framed so that every patient had a role in making it happen.  David Cameron said, with reference to patient data, that he wanted ‘every willing patient to be a research patient.’  The UK Clinical Trials Gateway (UKCTG) was re-launched so that every citizen could have access to information about opportunities to take part in research.
It would be a counterproductive if not harmful if the 2017 Strategy took a step back from this view of the world where we are trying to make the best use of all our assets – citizens included, to break the connection between the life sciences and patients and the public which we have done so much in the UK to forge over the last decade. I thought the academic and commentator, Jonathan Grant, put it well in the Times Higher a few weeks ago when he said:
This is not to argue that we should not be supporting curiosity-driven discovery research, but rather to suggest that we should learn to listen to what society wants from research. If not, research and research funding could be caught up in the anti-establishment populism that has characterised the past few years. This may lead to a shift in research priorities and portfolios, but that should be welcomed as it will strengthen the implicit contract between researchers, taxpayers and donors. But to listen well will require a move from a model of supplying “ideas” generated by researchers to one where we are more actively listening to our supporters’ “demand” for solutions.
Taking Grant’s cue, this is my third issue: will the Life Sciences Strategy  reflect what the nation needs or the preoccupations of dominant voices who, with the best intentions, find it difficult to see beyond blue skies.
Indeed, my experience is that this is one of those episodes in science policy – others being the Cooksey report, the credit crunch etc. – when my basic science colleagues rise up like the knights in ‘The Weirdstone of Brisingamen: A Tale of Alderley’ to protect the nation at its time of crisis. Or rather ‘curiosity-driven discovery research.’  To suggest otherwise, to even hint that this might not be the whole answer to our troubles, is seen as treason. The Tower beckons. And I’m not talking about the one next to the Thames.It’s a shame. Just because we question does not mean we are not also its greatest supporters.
One day a few weeks ago I spent the afternoon talking with service users, local voluntary groups and researchers about partnership; partnerships to improve health and wellbeing for the most needy in our society. They are passionate about science in all its forms. But their everyday experience is of helping people who are beyond the help of anything that the cleverest person can do to a molecule.  It is a societal need that is desperate and growing. All this in a stuffy room in the shadows of some of our greatest research institutions and shiniest research facilities.  But then we are often most blind to that which lies in our shadow.
Perhaps we should put the draft Life Sciences Strategy to the test in front of a public panel.

Polonius:
[Aside] Though this be madness, yet there is method in’t.

Hamlet Act 2, scene 2, 193–206

If you are in some way connected to public involvement in health research then you get used to ‘the look.’

Sometimes it’s a vacant stare or a gaze falling slowly across the face like the sun going down.  In other instances it’s a look of panic or sheer terror.  ‘Are you mad?’ you can see them think.  Then, ‘No, they’re serious and my world is about to be turned upside down.’  This, as they shift their weight from foot to foot.

Demonstrating the logic and rationale behind our passion is key to influencing these panic-stricken colleagues who have stumbled across our world for the first time.  Identifying methods and methodology that will not just work for them but make research better and their lives easier is key.  Refinement of this thinking and in ways that can be easily assimilated is one of the three grand challenges for public involvement.

It is my personal opinion that we are not doing nearly enough across the NIHR to learn from current public involvement practices, develop appropriate methods and methodology and then serve these up in a way which can be used easily by our friends colleagues.  INVOLVE has done some fabulous work in this area not least through its invoNET programme of work and its evidence library.  But others need to begin to demonstrate that they will be taking this agenda seriously if we are not to build public involvement on foundations of sand. Across the water, in Canada

The Health Services and Delivery Research Programme is currently on the hunt for future research topics (deadline, 4th December) and this may well be one route to boost efforts.  In the meantime there are some studies underway which I hope people will support.

To this end, I am passing on this invitation to take part in the Medical Research Council (MRC) -funded METHODICAL study – initially, a two-round survey to help agree which methods, practices and procedures of patient and public involvement (PPI) in clinical trials should be prioritised for future research…

The notice I received says..

We are looking for people with at least 12 months experience of PPI in clinical trials within any of the following roles:

  • PPI Researchers (e.g. those who conduct research into PPI in clinical trials and authors of guidance documents)
  • Non-lay Reviewers of trials (e.g. professional members of clinical trial funding boards /Research ethics committees)
  • Lay Reviewers (e.g. members of the public sitting on clinical trial funding boards/ Research ethics committees)
  • PPI Advisors across trials (e.g. member of Research Design Service (RDS) advising others on PPI activity, PPI advisors from funding bodies)
  • PPI Contributors (e.g. patient representatives, research partners in clinical trials)
  • PPI Co-ordinators (e.g. working for a Clinical Trial Unit (CTU) or research network to coordinate PPI activity)
  • Chief Investigators, trial managers and other researchers/staff who plan/oversee PPI in trials

Each round of the online survey will take about 15-20 minutes. Round one involves scoring the importance of a list of research topics on a scale of 1-9. About two months later you will be invited to complete round two, where you will be asked to review a summary of the survey responses and given the option to change or keep your original scores.

This type of survey is called a Delphi, and is a way of finding agreement amongst a group of people. To ensure the results are accurate it is important that as many people as possible complete both rounds of the survey.

Round one will be available to complete until Friday 11th December.

Some people who complete the two-round survey will be invited to a meeting in Liverpool, at which the results will be presented and discussed to achieve a final agreement of the research priorities. You do not need to be willing to attend this in order to complete the online survey.

More detailed information about the study is available in the attached document.

The survey can be accessed from www.methodicalstudy.uk

We would appreciate your help with the study. Also, if you think there are any persons or networks that this might be relevant to we would appreciate your help with the dissemination of this email.

The Medical Research Council (MRC) has published a refreshed communications and engagement strategy.

There is a section on public involvement on P12 of the document which is the fullest narrative I have seen of their corporate intentions around this aspect of working in partnership with the public.

It is a good document and important to have in the public domain. But I wish the public involvement part had a bit more ‘oomph’ in making a stronger commitment to involving the public in strategic and operational decision-making by the MRC. Also that it appeared earlier in the document and as part of the main strategic aims.

That might help to counter the views some people hold that the MRC’s default way of working with the public is to broadcast high quality
information. For the fact is that there are many excellent examples from the root and branch parts of the organisation which demonstrate how its researchers increasingly see what they do as a joint venture with patients and the public.

The MRC Clinical Trials Unit at UCL has, for instance, produced a set of stunning new videos about all aspects of public involvement including this one.

The strategy does these activities a slight disservice by underselling their importance to the overall strategy of the MRC. However, it does mark a degree of progress.

[This post is on the ‘asides’ pages where I tend to post short pieces. My full posts are on the main pages as usual]

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.

Off to Liverpool today. I am chairing a session at the Pancreas Society’s first ever PPI forum. This is the opener to their annual scientific meeting which takes place the rest of the week.

Last Friday was another first. I spoke to, and took part in, the inaugural meeting of the MHRA’s ( Medicines and Health Products Regulatory Agency) patient group consultative forum.

Is that the sound of broken shards from a glass ceiling I can hear beneath my feet? Let’s not tempt fate eh?

What else connects Liverpool to our drug regulator?

Well, just a few days ago in Liverpool, the Medical Research Council (MRC) and Sense About Science launched a new public guide on drug safely entitled: ‘Making Sense of Drug Safety Science: Investigating the science of side effects.’ And an excellent publication it is too in talking about side effects and how we are doing more to learn about them. You can find a copy here: http://www.senseaboutscience.org/pages/health-and-medicine.html

But there is more to this issue than increasing public understanding and awareness.

In my experience, drug safety is one of those issues where doctors, researchers and patients are a long way from reaching a satisfactory working relationship.

At root is the clash between ‘scientific evidence’ and ‘patient experience’ with the validity of the latter often disparaged. Typically this is couched in terms of ‘the hierarchy of evidence.’ It is an argument intoned with the same sort of words and feeling that we used to hear from members’ clubs about why it was necessary to exclude women.

We had such a question about ‘evidence’ versus ‘opinion’ to the patient panel from the floor of the ABPI conference last week. I also heard those arguments played out at the MHRA meeting but thankfully with good grace and a willingness on both sides to listen. The resistance to listen and respond is the jagged edge of regulation on which patients often cut themselves.

I am not sure that any patient or patient group is seriously trying to unseat the place of science in regulation. But I do hear them urge that regulators use different instruments according to the environment and context – as pilots do when flying in good weather or bad – to allow the patient voice to be heard more clearly. The same goes with doctors.

If seems foolhardy to me if regulators and the professions do not embrace the ‘informal’ yet undoubted richness of conversations that patients have about their medicines. And we have already seen with some drugs such as statins how the patient voice has been critical in changing practice and attitudes. Or in devising new tools like the medication passport developed by the North West London CLAHRC. If only the system might turn to such creative minds to develop a more patient-friendly yellow card system for reporting adverse events. We might get rid of forms for a start.

With vision we might see patients as an integral part of the regulatory system for improving drug safety. Not the inert mass to be protected.

Yes, regulation might just be the thing for them to cut their teeth on.

At least we are now at the table.

Yes, we are positively swimming in data these days.  And I don’t about you, but I’m looking forward to doing some data-linkage with family and friends over Christmas and the New Year.

From a Government point of view, making best use of the data which is routinely collected by departments, public agencies and others, linking it up and enabling researchers to interrogate it in a way which does not impinge on a citizen’s privacy, has been a big topic of conversation this year. What to do?

Well, the Economic and Social Research Council (ESRC), together with the Medical Research Council (MRC) and Wellcome Trust, established a taskforce in 2011 to look more deeply into the subject and has just produced its report and recommendations.  They propose the setting up of Administrative Data Research Centres (ADRCs) in each of the four nations of the UK, a single governance framework for them, a common approach to data storage plus some ground rules for publicly funded researchers to access the data held.

They recognise the importance of public engagement and say the overall Governance Board must have at least one lay representative and that each Centre should have a public engagement plan and resource to support it.  The report is here.

Meanwhile – and I mention it because I was on the review panel – NIHR has recently announced the successful bids to set up Healthcare Technology Co-operatives (HTCs) which will work collaboratively with industry to develop new medical devices, healthcare technologies and technology-dependent interventions in clinical areas of high morbidity or unmet need.  The areas covered include: chronic gastrointestinal disease, brain injury, cardiovascular disease, Devices for Dignity, wound prevention, colorectal therapies, mental health and trauma management.  Full details on the NIHR website here.

You might also wish to visit the NIHR home page right now where they have also just listed the year’s achievements – an impressive list.