Less haste and more speed is better for research and better for patients

The Government has today announced an Innovative Medicines and MedTech Review, beginning in early 2015. The Minister for Life Sciences, George Freeman MP, has set out a bold vision for cutting drastically the time it takes to develop and give patients access to new medicines and innovation. This news release lays out the basic aims of the review.

The language of urgency and desperation is a common accompaniment to the way in which medical research is pitched to the public.

Charities make ‘urgent appeals’ to our generosity.  Drug companies strain at the leash, only held back, they say, by red tape and grey bureaucrats.  Researchers implore us to come forward and ‘make it happen.’  Patients warn us of the human costs unless there is ‘immediate action.’ So it goes on.

They are right – or at least have every right, to make such calls. But we should be aware of the dangers to research and to patients of creating a society that is so pro-science, it forgets to ask important questions of science and itself for the matter.

At the moment, medical research has a burgeoning ‘fast movement.’  ‘Empower: Access to Medicines’ is one such lobby group that exemplifies how this agenda has come to the fore. Last week at the World Orphan Drug Congress I was struck by the number of patient organisations who came to the stand or spoke from the floor about the need for faster development times for new treatments, and speedier access to them.

Few people would deny that it takes a bafflingly long time and mind-boggling amount of money to produce new medicine; that there are surely ways in which this process can be shorted and cheapened. So no wonder Governments, major funders and regulators alike are doing all they can to make this happen – from adaptive licensing to the Health Research Authority’s (HRA) plans to establish a single approval process for approving research to happen in the NHS. (At the moment it seems everyone gets involved even the hospital porter!).

The more dangerous element to this movement is that which puts the pressure of demand – desperate and legitimate though it may be – in the driving seat. So much so that it tips the scale back towards a day when people were treated no better than guinea pigs, when doctors acted in haste or pure self-interest.

This is what is so worrying about the Medical Innovation Bill. In spite of what some patient advocates say, I fundamentally believe its passage would do serious damage to all that has been achieved in putting patient rights at the heart of the research agenda. Not to mention what it means for the enduring respect we have paid to ensuring research quality. In that sense it is the veritable wolf in sheep’s clothing. Goodness knows how it has got this far.

Clearly, as patients and the public, we have an important role in advocating for research to take place more quickly and for the fruits of its success to be made widely available. But we also have a significant role to play as active participants in research, working with researchers to make things work better and more efficiently. From being study participants to shaping its design and delivery. As the success of our clinical research networks bears witness to.

Patients and the public should be part of the pit crew not goading from the stands. That’s how we get faster, better research.

Public involvement in research to be turned into drama in groundbreaking new play

On my travels so a cut and paste of a news release about an exciting new project.

Those who know Y Touring will also be pleased to hear that it has found a loving home at last.

New theatre company: Theatre of Debate Ltd. announces inaugural project

Press Release: 13 November 2014

The creation of a new theatre company, Theatre of Debate Ltd., was announced yesterday by Nigel Townsend, former Director of Y Touring Theatre Company.

Theatre of Debate Ltd. will develop the considerable legacy of Y Touring, continuing to tour nationally with new writing that explores complex science-based issues.

Y Touring was an operation of Central YMCA, which toured schools, theatres and community centres nationally, exploring social and ethical dilemmas through its unique Theatre of Debate format. After 25 years Central YCMA closed Y Touring in September 2014.

Artistic Director Nigel Townsend said: “Now more than ever, as we move towards a population of more than 10 million and we face among many other challenges, the challenges of climate change and the food crisis, and the threat of disease, we need to engage our audiences in informed debate about our futures and the world we want to live in and the role science, the arts and digital technology will have in achieving that future. That is why we are excited at having the opportunity to keep the offer of theatre of debate open to young people through live theatre, digital technology and cinema.”

Theatre of Debate Ltd.’s inaugural production will focus on patient and public involvement (PPI) in medical research, with support from the Wellcome Trust, as well as a new partnership with the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC), a partnership of OUH NHS Trust and the University of Oxford. Theatre of Debate will develop this work, which will tour schools nationally, while working towards a sustainable future with new partners in the years ahead.

Dr Sophie Petit-Zeman, Director of Patient Involvement at the NIHR Oxford BRC, who was also Y Touring’s Scientific Adviser, said “This is a hugely exciting step for Nigel and his team and for us in Oxford. We were keen to work with Y Touring as part of engaging and involving patients in research, but with the creation of Theatre of Debate we can now build an enduring partnership capitalising on enthusiasms and skills across the BRC and beyond.”

Lisa Jamieson, Head of Engaging Science at the Wellcome Trust, said: “For 19 years, Y Touring has been one of the most successful and high quality projects in the Wellcome Trust’s Engaging Science portfolio, and is extremely popular with students and teachers, as well as researchers, charities and the wider public engagement community. We look forward to seeing how Nigel and his team grow, bringing their inimitable approach to tackling tricky issues to new and varied audiences.”

Who’s making way for who in public involvement?

This morning I listened with interest to the news item about today’s Court of Appeal proceedings on whether wheelchairs users have precedence over parents with pushchairs on buses.

I know where my sympathies lie. With the wheelchair user. On balance, the consequences of denying them access are likely to be more serious and difficult to manage.

There also would seem to be a difference between applying hard fought for rights in a world that largely manifest itself as inaccessible, and widening choice for those for whom it already exists. But maybe not as much as they would like in a perfect world.

I can’t help also observing the self-righteousness with which some parents now push buggies before them (often the size and colour of small armoured cars) through crowded restaurants and streets sending the innocent into disarray. As a parent you wonder what it is they possibly fear so much to behave in such an antisocial way.

Of course the fault does not lie with any poor bus user. Rather it is at the door of the bus company, how it manages its buses and trains its staff.

But is that totally true? Does the episode that has reached the Court of Appeal tell us as much about how it is no longer the social norm to make room and accommodate others. If it was ever thus of course.

Put a hoard of carefree children, tired workers and hassled parents on a bus together and things can soon become incendiary. Even in the short 11 minute journey to our local rail station as I can testify.

Public involvement can have the manner of a bus at times. An increasingly crowded one. In September 106,000 people visited INVOLVE’s website. Two years ago it was less than one fifth of that.

Yesterday the Kings Fund put out a report about public involvement written by device users and carers among others. They note that, in their view, little progress has been made in public involvement. A glass ceiling does indeed exist and the Kings Fund is one of those organisations that – admirable though it is – has found it difficult to find room for service users in how it is governed. Go figure.

Yet it is not just about organisations making space and enabling choice. It is also how we behave towards one another.

I find it faintly dispiriting to see people collect all sorts of public involvement positions as medals on a lapel rather than offer these openings up to colleagues; especially to those who are at the beginning of their journey in public involvement. In fact this is much more troublesome to me than the curse that is more often cited – that of people staying around too long.

Listen to boardroom leaders and they will often comment on how the secret of their success and what they are most proud about is nurturing the talent around them.

We all have a responsibility to do the same, to nurture the talented and interested and make room for others.

Ireland gets to grips with public involvement in research

There are two ways to get to Dublin City Centre from the airport by taxi. You can either join the traffic that wends its way slowly overground. Or you can take the Dublin Port Tunnel which gets you there in no time at all. On behalf of all harried travellers, can I thank the person who had the vision of a tunnel.

I was in Dublin on Tuesday to attend the Irish Health Research Forum’s conference on public involvement. The Forum was set up earlier this year following a study of the research landscape in Ireland conducted by Professor Bernie Hannigan and commissioned by the Medical Research Charities Group (MRCG) of Ireland. It is worth mentioning that Professor Hannigan has recently been appointed the Director of R&D at Public Health England.

The Hannigan report entitled: ‘Health Research Landscape in Ireland: What Researchers Say’ recommended that MRCG bring together a wide coalition of partners to promote and advance health research (the aforementioned Forum). But also that there needed to be more focus on the development of public involvement. Hence yesterday’s event, a first I believe.

It was flattering to say the least that the Forum had turned to some familiar names from the UK to provoke thought and discussion: Angela Coulter from Oxford, Jennie Poppay from the University of Lancaster and Liam O’Toole from Arthritis Research UK. We are undoubtedly further ahead of them in many ways in putting public involvement on the agenda. As are other countries such as Denmark represented there by Mogens Horder.

But as we were quick to stress, it is too easy to let the shine of our successes blind us from seeing our failures over the last twenty years. They may well learn from these but we can and should also learn from the fresh approaches they will take. And with emails in my inbox from Sweden, Norway, Canada and France, we can be sure of new and innovative ways forward. A fact that is both inspiring and exciting.

Thinking about the Forum and its future role, I believe that one important and highly strategic failure has been our inability thus far to develop a shared vision among charities, Government funders, HEIs, industry, NHS England and academia about the future role of the public in health research. There have been attempts, not least through the United Kingdom Clinical Research Collaboration (UKCRC). The problem isn’t so much that people are doing their own thing. It is that these ‘things’ aren’t pushing in more or less the same direction.

Another – and I should credit Jennie Poppay for saying this at the meeting but you will here me say a great deal more about it in the coming weeks – is that lots of reasons (good reasons I should add) are given for doing public involvement. From making it more accountable to increasing the numbers of people in a study. However, focus on these reasons and the activities that might support them has perhaps led to us astray from our original purpose.

This mission is for the health research system to treat the knowledge that patients and the public gain through experience, as currency of equal value to other forms of expertise in the knowledge economy that’s going to be necessary to create to improve health and wellbeing.

I also enjoyed the comments by Eibhlin Mulroe, CEO of the Irish Platform for Patients’ Organisations, Science and Industry and Task Force Leader, EUPATI Consortium. As someone who has just entered the sector she reflected on how amazed she was that in medical research we don’t do what’s second nature and talk to the market first about the products that are needed and desired.

Hear, hear. That’s just tunnel vision. And to be avoided at all costs.

Lit runways and other language pitfalls – or should we say ‘crash landings’ – in science.

I went to a listening event hosted by the new Life Sciences Minister, George Freeman, yesterday. It was rather good. One of the better ones I have attended over the years. So well done him. And well done those who ran it.

During the course of the event, I came across a new term – ‘lit runways.’ Well, new to me. It was being used in the context of trying to speed up access to medicines for patients by shortening the development time. The idea being that if you can see the runway lights you can land safely and soundly without delay.

Now I’m not one to knock a good metaphor. After all I seem to remember once being lambasted by a Daily Telegraph reader for the number of metaphors I used in a letter to which he was responding in print.

And all Governments have new ways they wish to articulate their policy ideas. David Willetts had ‘clusters’ for breakfast. I seem to remember Lord Drayson ‘catapulting’ faster than one of his racing cars.

But yesterday afternoon I did begin to wonder.

For as soon as I heard the words ‘lit runway’ I recalled a story in which an airline pilot was severely reprimanded by his airline (he may, in fact, have been sacked) for mistaking the M4 as Runway 27R at London Heathrow Airport.

Luckily he realised the error of his ways before his wheels struck the roof of the Queen’s car taking her back to Windsor (I made that bit up). Perhaps he knew something we don’t about runway expansion in the South East of England.

The point is that it’s all very well landing on a lit runway…as long as it’s the right runway.

So, listening to the absorbing debate among colleagues I was encouraged by the number of times people talked about ‘empowered’ patients being fundamental to the future success of UK research and success.

I couldn’t have put it better. But if they really mean it then it means accepting that patients and the public must be part of the construction crew that builds the runway.

If not, we will simply building runways to destinations not of patients’ choosing. And no one wants to land there.

Night night.

A research active NHS is Impt to patients, NIHR survey shows. Minister for Life Sciences quoted

The following is the news release put out today by the National Institute for Health Research (NIHR) Clinical Research Network with new survey data about public opinion on clinical research and the role of the NHS.

Starts here:

A new survey conducted on behalf of the National Institute for Health Research Clinical Research Network (NIHR CRN) shows that 89% of people would be willing to take part in clinical research if they were diagnosed with a medical condition or disease – with an all-time-low figure of just 3% saying they would not consider it at all.

The survey also revealed that 95% of people said it was important to them that the NHS carries out clinical research.Last year over 600,000 people took part in research which aims to improve diagnosis, treatment and care of patients in the NHS. The growing importance of clinical research to the general public and their increased willingness to take part suggests that this number is set to rise.

Commenting on the findings of the survey, the NIHR Clinical Research Network’s chief executive, Jonathan Sheffield, said:

“It is important that we make information about clinical research opportunities widely available to NHS patients, through as many routes as we can. This survey shows that people want to participate and we need to ensure they are made aware of the research opportunities available to them. Through our local Clinical Research Networks, we will continue to actively work withal parts of the NHS to promote research opportunities for patients.

“The survey also shows that although 77% of people are awarethat clinical research happens in hospitals, they are less informed about opportunities to take part at their local GPs – even though our data shows that one in three GP practices is research active.

“Clinical research happens in the majority of healthcare settings from hospitals to Ambulance Trusts and from Mental Health Trusts to Community Hospitals. I would urge people interested in research to examine all opportunities as anywhere there’s an NHS patient, there should be an opportunity to get involved in research. Part of our role is guiding healthcare professionals to ensure that they are promoting research and we have produced materials to help them do that.”

When asked about motivating factors for taking part in clinical research, nearly half of the people surveyed said that receiving a diagnosis for a medical condition or disease would be a factor most likely to motivate them. One in five said that they would be motivated if a friend or family member was seriously ill and an appropriate treatment had not yet been developed. On this Jonathan Sheffield said:

“It is important to know that many research studies also involve healthy volunteers. We see a lot of carers, friends and family members of patients who are diagnosed with a condition or disease come forward to take part in research. It can be reassuring for them to be able to contribute something which could help a loved one.Research gives people the opportunity to affect future care, whether they are affected themselves or not and patients can find that very empowering.”

Simon Denegri, NIHR National Director for Patients and the public and Chair, INVOLVE said:

“Patients, carers and their families want to see their local NHS carrying out research to improve care and they want to help to make this happen. That is clear from this survey as well as the hundreds of thousands of people who volunteer every year to take part in clinical research.

“Our hospitals and GP surgeries need to be makinginformation readily available to patients so that they know it’s ‘OK to ask’ about research. The research we do with patients today is the quality care that our NHS will deliver tomorrow.”

Minister for Life Sciences George Freeman said:

“The NHS provides a unique setting for the development of new treatments that can bring real benefits to patients. We have world class research facilities and it is clear that patients want the opportunity to take part in clinical trials. Ensuring that the NHS continues to embrace research will help us realise our ambition of making the NHS is the best health service in the world."

Patients interested in research can visit: http://www.crn.nihr.ac.uk to find out more about taking part and see what research is happening in their local area.

- Ends -

NOTES TO EDITORS:

About the NIHR Clinical Research Network

The NIHR Clinical Research Network is part of the National Institute for Health Research. We provide researchers with the practical support they need to make clinical studies happen in the NHS, so that more research takes place across England, and more patients can take part. This practical support includes:

• reducing the “red-tape” around setting up a study
• enhancing NHS resources, by funding the people and facilities needed to carry out research “on the ground”
• helping researchers to identify suitable NHS sites, and recruit patients to take part in research studies
• and advising researchers on how to make their study “work” in the NHS environment.


Patient case study

Lucy Norman was diagnosed with Parkinson’s aged 38 when she began to struggle with her job as a former NHS PA in London. After taking part in research Lucy’s quality of life has greatly improved. Lucy now volunteers with charity Parkinson’s UK and is involved in village life, from being co-chairwoman of the village hall management committee to helping run the monthly market.

Angus, Lucy’s husband, aged 64, also took part in the five-year study alongside his wife Lucy as a healthy volunteer, at Oxford’s John Radcliffe Hospital. The study is looking at a test to speed up early diagnosis for Parkinson’s sufferers.

Angus said:

“Taking part in the study was so beneficial because it was something that I could do personally to help Lucy,because sometimes you can feel helpless in situations like that. The opportunity to take part and give something back really illuminated the whole concept of clinical research for me.

“I understand how important and valuable it is now. And it wasn’t hard at all; I simply took the same tests that Lucy did. It’s something we can do together for Parkinson’ssufferers. It may seem like a small contribution in the world of clinical research, but personally, it’s a big contribution for me, to help my wife and others like her with medical conditions – and that’s a fantastic achievement.”

Associated links

http://www.crn.nihr.ac.uk – Website for the Clinical Research Network (CRN)
http://www.crn.nihr.ac.uk/can-help/patients-carers-public/ – The CRN’s general patient and public information pages
http://www.nihr.ac.uk/get-involved/ok-to-ask.htm – About the NIHR’s OK to ask campaign
http://www.crn.nihr.ac.uk/patientstories – About the CRN’s Patient stories campaign

Contacts

For interviews, images and more information:

Part II of ‘How to be a lay reviewer of health research:’ Being on a scientific review panel

Last week I posted my top ten tips for patients and the public (‘lay reviewers’) who have been asked to review applications for health research funding.

Today I thought I would share my thoughts on what to expect when asked to be on a review panel; how to best contribute to the panel’s work in general and; what to consider when raising issues around public involvement in such a setting.

Funders establish review panels or committees to help them reach a decision about what research to fund. The panel can be asked to look at anything from projects lasting a few years and amounting to a few tens of thousands of £s, to larger programmes running over 5 years or more. Or to approve what is often called infrastructure (a
collaboration, new venture or perhaps organisation) amounting to many £millions. Some are ‘standing’ committees that run for years. Others are convened for a particular grant round or task.

The important point about review panels is that they are there to reach an independent viewpoint on whether an application is worth funding. These recommendations are then made to the funder who takes the final decision (perhaps it’s Board or a committee with delegated authority to do this).

As a lay member you have been asked by the funder to work with the other experts around the table to reach a consensus on whether the application should be funded. Likely considerations in reaching this view include whether it is a good idea, based on sound science, fits with the criteria set down by the funder, will be well run and led, involves the public and represents a good investment.

Probably the one thing that will strike you if you ever sit on such a panel is the amount of effort put into making these things work fairly, transparently and efficiently.

There can be as many as 30 people on larger panels but around 10-12 is more typical. As well as assembled experts like yourself there will likely be a number of representatives from the funder present. They are sometimes known collectively as the ‘Secretariat’ and have a number of roles. They are there to make sure an accurate note is taken of the decisions taken and the reasons behind them (people do challenge them!). And to advise the panel Chair and its members on things like funding criteria.

There’s also usually a lot of paper! However, it does seem that more and more people come to the meetings and work off their computer or laptop. You might wish to do so if you have one and feel comfortable working like this. Some people continue to prefer paper.

Anyway, here are my top tips this time:

1. ‘Preparation is all you need.’ Yes, as ever, the key to feeling confident as a lay reviewer on a panel lies in good preparation. Sounds obvious but when it goes wrong for me it’s often because I have short-changed myself on prep time. Leaving enough time to read the documents, get to the venue and sort out your papers on arrival, is very important.

Otherwise you will appear at the meeting – late! – like a living approximation of Boris Johnson’s hair after he has woken up: endearing perhaps, but lacking in gravitas most certainly. And you want to be taken seriously. Sorry, but first impressions do matter.

However, your preparation really begins from the moment you become a member of the panel. So, before agreeing to be on it, clarify how you are going to be supported. Can you get hard copies of the papers if you want? Can they arrange travel and accommodation if necessary? Will there be any training or induction provided? Will they be using accessible venues and review formats?

2. ‘Knowing me, knowing you.’ It is worth taking some time to get to know the members of the Secretariat – particularly the panel administrator or secretary – and, if possible, the Chair, before the meeting.

A good funder should make time for this to happen in advance of the first meeting. If not in-person then by phone. It’s the opportunity for you to ask questions about the process, how they run things and clarify practical arrangements.

Getting to know the Chair will also give you an idea of the
‘personality of the panel.’ His or her style of Chairing will have a strong bearing on whether the panel feels formal, informal or simply chaotic.

If a pre-meet or similar does not happen, you should take the initiative on arrival and introduce yourself. And ask to meet with them some time in the future if you will be on the panel for some years. It’s important to have a good relationship with those running the shop. Don’t forget they need you as much as you need them – it really is an enormous headache for administrators to find panel members and they won’t want to lose you.

One last point on this is that I would expect a good Chair to always give the lay member(s) an opportunity to say something if they want to (see below for further guidance!) as each application is looked at.

3. It’s ok not knowing everything.’
No one else on the panel knows everything (although they might like you to think that they do) so why should you? Ask questions where you think it might be important to clarify something. In fact asking questions is one of the most valuable things any reviewer can do. I have seen the most innocent of questions completely blow open an application. What do they say: ‘The only stupid question is the one you don’t ask.’ However…..

4. ‘Less is more.’ I think this is where people generally go wrong in all sorts of meetings, not just review panels. They don’t just take the floor, they hog it. Until we are all so bored and frustrated that it can infect the whole proceedings.

It’s important to bear in mind that the panel may be looking at 10-15 applications in a day with 15/20 minutes to look at each. So, have your main points ready to share. Two, perhaps three at most. But maybe it’s really not worth mentioning the spelling mistake or poor grammar. You must focus on those things that you think either make the research excellent or unviable from a public involvement standpoint.

5. You don’t have to find something to say about every application.

6. ‘It’s not just about public involvement.’
Often when reviewing you are asked to focus on public involvement in particular or even score only that part of the application. I don’t have a big problem with that. But you have every right to comment on things outside of this. For instance, it’s not uncommon for panels to interview the applicants these days. You can tell a lot by body language and how they interact with one another. And unless I’ve missed something, patients and the public have eyes and ears as well. Use them.

6. ‘Be prepared to meet yourself.’
Talking of researchers being interviewed…

One day, as a teenager, I was standing at the bar in a pub. A man kept looking at me from the other side of the counter. I became
increasingly disconcerted as this wasn’t a pub to be conspicuous in. And then I realised it was my reflection in the mirror behind the bar.

At some point, a team will appear before the panel with a patient, carer or member of the public alongside them. They might be a co-applicant. They might not be. The point is, if they are there, then I think you should ask them a question. Particularly if no one else has. What you want to know is: how much part of the team do they feel? Why are they there?

7. ‘It’s ok to lose 5:1.’
Most review panels use some sort of scoring system to help them reach a decision. Typically you are asked to give your score as part of your initial assessment (sometimes in writing before the meeting, sometimes at it) and then there’s a period of moderation in the panel to reach an agreed score. This happens once everyone’s opinion has been heard.

The first time you are informed you have to do this I guarantee you will panic. In the same way that you would if asked to turn up with the same colour underwear as your other panel members. How will I know? Will I look stupid? How do they know? Is there a secret code or initiation ceremony?

The important point is, you must give scores that reflect your opinion based on the criteria given. No one else’s. If you can support it with a cogent argument, people will respect you. Nor should you play safe by putting everything in the mid-range. That would be like living with a Liberal Democrat.

8. ‘Good manners go a long way.’ However much you dislike an application or are irritated by the applicants, keep your cool. The best demolitions of ideas and arguments I have heard have been those that are softly spoken and measured in tone.
You can always kick and scream in your hotel room afterwards like the rock star you always wanted to be.

9. ‘Your responsibility doesn’t finish at the door.’
My experience is that whatever we might think of our colleagues running these panels, they are actually trying to do the right thing. It’s hard work. Complicated. Inflated egos surround you. The wheels of the institution you work for often turn slowly.

So your feedback can be enormously helpful to them. If it’s positive don’t hold onto it. If it’s negative, share it but do so
constructively with one or two suggested solutions.

If your experience is a bad one, then ask the Secretariat how you raise this with them and the Chair. Get it dealt with but don’t let it fester.

10. ‘Safety in numbers.’
If there’s a.n.other lay member on the panel – and there should be – work together. You should not collude in how you reach an opinion or score but you can share thoughts about the things you look for, any trends in the applications and more. You will also have respective strengths that might complement each other when the panel meets.

Suggest to the organisation that all the lay reviewers are supported to get together to review how things are going. This could be helpful to improving the scheme in the future.

And finally…

The only other thing I would say is that when I started doing this I found being on a panel one of the most intimidating experiences of my life. But now it is one of the most enjoyable. It’s interesting. I love meeting and working with old and new colleagues. And I feel privileged to get to see so many good ideas in gestation.

Enjoy.

The only other thing I would say is that when I started doing this I found being on a panel one of the most intimidating experiences of my life. But now it is one of the most enjoyable. It’s interesting. I love meeting and working with old and new colleagues. I feel privileged to get to see so many good ideas in gestation. /

Simon Denegri
Chair, INVOLVE
NIHR National Director for Public Participation and Engagement in Research Twitter: @SDenegri
Please visit my blog at;
http://simondenegri.com/