clinical trials

This week I had the good fortune to be on the judging panel for the NIHR Clinical Research Networks/McPin Foundation/MQ 2018 award for service user and carer involvement in mental health research.  It was a brilliant field to choose from. The winners will be announced very shortly.

One of the reasons I readily take up invitations to judge such awards – apart from the fact that I enjoy it – is that it is an excellent way of keeping up with what’s going on, the challenges and opportunities. This week was no exception.

Retention in public involvement

I am sure that I am not breaking any confidences if I say our deliberations highlighted once again the issue of ‘retention’ in public involvement. Or to put it more simply: helping people to ‘stick with it.’  Supporting service users and carers to remain involved and feel they are making a difference. Supporting researchers and research teams to remain committed to involvement. Building and maintaining relationships against an often chaotic background requires investment of many sorts by all partners: energy, passion, emotional commitment, resources, training. The list goes on.  Flexibility, a sense of humanity and an underlying philosophy of mutuality, staying true to values and principles tend to mark out the best teams (and by teams I am including patients, carers and the public).

Much as we talk about public involvement being a relationship business, the actionable evidence on how such relationships can be supported and sustained is weak. I am glad that some are now ‘on the case’ so to speak – read this blog report on a recent event in Manchester by the excellent Bella Starling for instance. See also this by healthtalk.org.

As a tangent I would also encourage people to read this week’s BMJ editorial by Kristin Liabo, Nicky Britten and others on clarifying the roles of patients in research. It is a reminder that being clear about roles and setting expectations is fundamental to getting such relationships off to the right start.

Retention in clinical trials

Then there is the matter of retention of people in clinical trials as participants. I was interested to see this recent survey by Applied Clinical Trials and SCORR Marketing as reported in ‘pharmaphorum’ which pointed to retention in clinical trials being a key metric for ‘patient engagement’ by pharmaceutical companies. Yet the same survey shows that most companies are performing poorly in terms of investing in their relationship with patients.  The NIHR CRN have done annual surveys on patient experience in trials for several years now and the results consistently show that relationships with staff are one of the key factors in maintaining people’s motivation to stay in a trial.  My anecdotal ‘add’ to this would be that the role played by clinical research nurses in this respect continues to be underrecognised.

But enough of the anecdote. If you want to help highlight the factors that help people stay in clinical trials then you can do no better than complete the survey being run by the PRioRiTyII project here. #PRioRiTyII

Staff retention

Another dimension to ‘retention’ which we need to talk about is that of our staff. It is an issue I care about deeply as NIHR National Director because of the growing number of colleagues fulfilling ‘PPI’ roles across the NIHR.  Passionate, committed, skilled, experienced, creative and yet sometimes regarded as curiosities in their own organisations. It reminds me a bit of when I was a ‘communications person’ (that’s what we were referred to) way back in the early ’90s. Now of course it is a brave organisation that goes into the public arena without the support of their Director of Communications.  How times move on.

Being the interlocutor between organisations and patients, carers and the public, facilitating, building and maintaining relationships between partners is not an easy ask. The work is more often than not rewarding and the sense of job satisfaction very high. My neighbour who came round for a birthday drink (hers not mine) yesterday said she thought it sounded like the best sort of work in the world.

But for some the working environment is difficult. In other instances it is openly hostile. Email bounce-backs from organisations – and what they say – are an interesting indicator for me of an unhealthy churn in personnel.  Some staff are not easy to deal with. Some patients, carers and members of the public are not easy to deal with. It can feel exhausting, demoralising to feel you have to beg for small scraps of money in multi-million £ institutions.

Truth be told we do not do nearly enough to support the growing number of men and women working across many health research organisations now supporting public engagement and involvement.  I am very conscious of this. Recently I have been talking to PCORI and CIHR in the US and Canada – where the same issues are being faced – about whether there is something to be developed jointly.  INVOLVE has a critical role to play of course. There are links to be made with what the university community is doing through the National Co-ordinating Centre for Public Engagement. Perhaps ‘PPI leads’ could begin to form themselves into a professional grouping as science press officers have done very successfully.  See the work of Stempra.

Staying the course can be hard to do whatever our role in research.  A more open discussion about the issues is important. We need to recognise the factors that contribute to mutually supportive relationships. An honest appraisal of what it takes to sustain these and a readiness to resource this effort is needed by funders and organisations

But in the meantime I hope you’ll be sticking with it.

I am.

There is much post-Brexit talk of using our new-found political independence to liberalise clinical trials in the U.K.

We can cut ourselves free of all that terrible EU red-tape that has weighed us down. Or so the argument goes. We can be quicker and more efficient than other countries. We will be more attractive to research funders and the global pharmaceutical industry in particular.

I am not so sure it will be that easy to extract ourselves completely and utterly judging by the furrowed brows across Westminster and Whitehall.

Nor am I sure we can lay the blame for our trials and tribulations in clinical research totally at the door of the EU. That’s if you accept the picture of doom and gloom that has been painted. I don’t.

We have recovered our international position well in clinical research in the last 10 years. Just look at the number of trials that are first to recruit in the U.K. This is down to the NIHR and its willingness to take on a range of vested interests at home – interests that were far more of a barrier than any EU law.

What I do know is that if things go belly up in the future we won’t have the EU to use as a punch bag. We will only have ourselves to blame.

The yet to be published and ironically named Accelerated Access Review is just such an example of how we are quite capable of slowing things down on our own in the UK. Right down until all the voices are distorted. We really don’t need any help from others.

Not everyone will greet the idea of liberalising clinical research with unbridled enthusiasm. The consumer experience of deregulating markets and cutting red tapes is not always wholly positive. Choice can come with a price. I say this as a frequent passenger on a semi-rural bus service. Need i say more.

Frankly, I wonder whether liberalisation is really the best we can for a post-Brexit moonshot. Surely liberalisation is the means to an end not the end in itself?

I would much prefer us to use liberalisation as a platform for the UK to change the face of clinical trials globally. To be the one that everyone watches.

To become the most innovative nation when it comes to clinical trial design; to be the nation that understands and reflects the patient experience of research better than ever; to be the nation that involves patients and carers in designing all its trials because this way leads to greater effectiveness and efficiency. Total public involvement in the way that Barcelona FC play ‘total football.’

However we got here, we now have an opportunity to do something amazing with patients and the public.

You probably don’t need to hear another thing about the EU, do you?

(By the way what a terrible EU referendum campaign it is – have you ever heard such hyperb******s from our politicians?)

But this really is a good thing.

Following the passage of the new EU Clinical Trials Regulation, the European Commission has started to issue consultation papers on the implementation of its different parts.

One of these concerns the provision of clinical trial results in a format that is understandable by the lay person.  It was issued on 1st June and is out for consultation for three months.   The actual document can be found here. And the page that details the consulation process is here (you will need to scroll down as there are three different consultations).

An important aside is that the guidelines were developed by an expert group led by the UK’s Health Research Authority (HRA) and chaired by the former Chair of INVOLVE, Sir Nick Partridge. So, quite a feather in the cap for the UK.

Interestingly, the HRA points out to me that it was not possible to refer to reading age in the document because only the UK and the USA use this concept and it is not commonly used across the rest of Europe.

You learn something new everyday but only if you are working with others.

 

 

My tickets for the FA Cup Final arrived in the post yesterday. I am very excited indeed.  I have a feeling that my team will bring the trophy home to south London where it belongs.

It is that time of year when football fans are living on their nerves as their team battles to win promotion or stave of relegation.  Fortunes – in every sense of the word – can change in seconds: a goal, a penalty decision, a sending-off.  Who knows what it will be?  I don’t expect everyone to understand this but to paraphrase Maxine Peake in the long-running legal drama, Silk: ‘It’s not about the football, it’s all about the football.’

You could say that, ten years ago, UK was in a battle to stay in the big league of countries doing clinical research.  Now it is regularly in the Champions League and often carries off a trophy or two.   The National Institute for Health Research (NIHR) has been instrumental if not pivotal to this success story.

I am deeply proud of the fact that patients and the public have not just featured in the NIHR story but have become an integral part of the NIHR team up and down the country.  It will be good to see many of them at a conference on Wednesday to mark the ten-year milestone.  I am particularly looking forward to taking the stage with a few of them to talk about how patients have made a difference to NIHR and what more we can do together in the future.

My passion for clinical research – like football – is very much a heart thing.  In fact when people sit down to explain the science to me I sometimes have the same expression on my face as someone trying to understand the off-side rule in football for the first time.  Perhaps I shouldn’t admit to things like that.  Nor, sadly, that I have been known to punch the air with joy at a news story about the latest, greatest piece of research. Just as I might a goal.

The sense of union one feels as a football fan – standing with thousands of others like-minded supporters – is conveyed in the singing of course.  Sometimes ebullient, often funny, occasionally imbued with a rich vein of gallows humour.  One of those chants is where the seated crowd are implored to ‘Stand up if you love….’ [insert team name].  And so we do, with alarms aloft, bellowing for our lives.

This time next week, across NIHR and the NHS we will be imploring people to do the same in the name of clinical research for International Clinical Trials Day (ICTD).  As I like to say to people, the NIHR ‘OK to Ask’ campaign and ICTD is more than just another awareness event.  It’s a pop-up festival with a purpose.

To shout loudly and proudly to patients and families across the UK that there is NHS research happening on their doorstep from which they might benefit. To thank the millions who have participated in studies to find new treatments over the last decade.  To enable patients, researchers, clinicians and health professionals to come together as a team and show others what they have been doing together in the name of research. With exhibition stands, events, tweet chats and a whole lot more at hospitals and institutions around the country from 20 May until well into the early summer.

UK clinical research is the team to beat.

OKtoAsk poster 2016

 

 

 

 

 

I do not ascribe to the view that you have to be ‘scientific literate’ as a pre-requisite to taking part in science.  In the same way that I do not think you need to be fluent in French before you can enjoy a holiday or set up home there.  Nothing beats immersion in the way of life in my view.

But I do believe the opportunity to learn beforehand can go a long way. It can build confidence. It can help you navigate the unfamiliar.  Plus it’s fun and exciting to feel as though you are learning new things.

Late last year the National Institute for Health Research Clinical Research Network (NIHR CRN) pioneered a new, free online course – otherwise know as a Massive Open Online Course or MOOC for short – entitled ‘Improving Healthcare through Clinical Research.’  It is open to everyone – from patients and the public to health professionals.

The course looks at the detail of research and how we do it. Brought to life through case studies, it covers topics such as; how research is helping to find new ways of treating and providing care for some of the major diseases including cancer and dementia. It also focuses on important ethical questions raised by clinical research.

It appears to be taking the world by storm. Quite simply thousands of people from around the world have signed up to take part in its first showing and raving about it.  Everywhere I have been this week – from Manchester to London – I have met people giving it five star reviews. One patient said it was ‘fantastic.’  Another person described it as ‘brilliant.’

Here you can watch a new NIHR CRN video in which public contributors talk about the course and what they liked about it.

And the great thing is that if, like me, you missed it first time round you can now register for the next course beginning on 6th June.  Somehow it feels appropriate to be opening a new

I’m off to register and I hope you will to.

 

It’s one of the hardest things they will have to do.  It is physically and mentally draining.  For many it will feel a lonely place.  The atmosphere will be unlike anything they have ever experienced before. Some will feel as if they are in a state of suspended animation. Others will feel as if they have leapt off a cliff into the unknown. One thing is for sure: the world will never look the same again. And there is work to do, more often than not in the shadows.

Yes, today, tomorrow and for ever after, patients will be stepping into the unknown by contributing to research for the first time. As a volunteer on a clinical trial. By joining an advisory group to help researchers design their experiment.  By reading research proposals…

Each will be spacewalking in their own way.

This week we learnt a bit more from NIHR CRN about how cancer patients feel about taking part in research. They want to benefit from new treatments. But they would also like more information about what it is they are testing. They also think they should get to hear about the results.

We learnt from healthtalkonline that for researchers public involvement can also feel like stepping into the unknown.  Those who have done it, encourage their colleagues to learn from those who have, that they should not feel alone.  Many talk about the motivation gained from working with those who will ultimately benefit from their work.

We also heard how industry and patients – for such a long time on different planets – may be beginning to occupy the same orbit if not come together.  A EUPATI paper published in BMJ Open showed that lack of knowledge of one another is a barrier to closer collaboration and partnership.  For many companies, public involvement does not land well with them because it feels too nebulous a concept.

study of public involvement in primary care published in ‘Research Engagement and Involvement’ highlighted how the sustainability of public involvement was predicated on ‘organizational commitment and leadership, adequate resourcing and dedicated support infrastructure.’  Ground controllers to note.

Finally and fittingly, it seemed only right to mention this absorbing piece from Forbes magazine about David Bowie’s connections with science and medicine.

Well done Tim – you will have earned your rest this weekend.

To patients and the public everywhere who are stepping outside the capsule next week – and perhaps for the first time – good luck!