clinical trials

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.

 

We are the only country which runs a public awareness campaign across our national health system to encourage people to participate in clinical research – NIHR ‘OK to ask’.  We’ve been doing it for three years on the trot to coincide with International Clinical Trials Day (ICTD) in May.  Now we want your views on how this year’s campaign went and what we should do next.

It doesn’t matter if you are a local organiser for the ‘OK to ask’ campaign, a patient or carer who took part in an event, a researcher or clinician who helped out.  We want to hear from you. And if you need a little reminder of what happened here’s a ‘storify’ of the year’s events.

But even if you have never heard of the National Institute for Health Research (NIHR) (let alone ‘OK to ask’) before, we’d still like to get your views.  For what you tell us will be used to:

  • produce a report about the ‘OK to ask’ campaign in 2015 this year which will be made publicly available on NIHR’s website and through our networks.
  • think about and plan our public awareness work about research for the future.

You can complete the online survey by clicking on the link here.

And there’re plenty of time to also send on to your friends and colleagues because the survey is open until Friday 11th September 2015 to respond.

Thanks in advance for your help.

Best wishes as ever,

Simon Denegri
NIHR National Director for Patients and the Public in Research
Simon.Denegri@nihr.ac.uk

Happy International Clinical Trials Day (ICTD) 2015 everyone!

Today over 100 NHS Trusts will be taking part in NIHR’s ‘OK to ask’ campaign aimed at raising public awareness of clinical research and encouraging patients to take part in clinical studies.  There will be displays in hospital receptions and staff canteens, mock trials with chocolate (yummy!), Open Days and talks.

But this year the #NIHRoktoask campaign has also taken to the streets.  There’s a ‘Research Bus’ touring town centres in Gloucestershire, a ‘Research Trail’ for young people at Great Ormond Street, town halls being taken over, ‘flash mobs’ in city centres, and information stalls outside  supermarkets (with even more chocolate I hope).

Social media has been particularly active this year.  If you have a spare moment this lunchtime (Wednesday 20 May) I hope you will take part in or listen to the Medical Research Council Clinical Trials Unit (MRC CTU) ‘tweetchat:’ ‘Why do clinical trials matter?’, with #trialsmatter as the hashtag.  They have four panellists who will be answering questions, and the Q&A will take place from 1-1.45 BST on Wednesday 20th May.  More details here.

You may also like to read the transcripts of the other twitter conversations NIHR has hosted on (just click on the relevant disease): cancer, diabetes, dementia, mental health, and stroke.

A quiet revolution is taking place.  Now in its third year the #NIHRoktoask campaign is a movement from the ground up.  It is driven by the passion and commitment of patients, researchers, nurses, doctors and managers working together to share the message that clinical research is vital, that it needs patients and healthy volunteers to come forward if we are to find new and better treatments and therapies. And they should be encouraged by what other patients tell us.

Our UK Clinical Research Facilities (UKCRF) Network will today be displaying a poster in their unit which shows the results of a survey they have done with over 700 patients about their experiences of research.  99% said that information was explained clearly to them on their visit – often with the help of patient and public volunteers, 97% said they would recommend taking part in research to their friends and family.   You can find the survey results here.

A few mornings ago I was walking down a London Street and passed one of those electric cars having its battery charged.  With its plug and long, dangly wire it seemed rather incongruous.  The scene would have been inconceivable ten years ago.  But not now. In fact, we might all be fighting over ‘car chargers’ rather than parking spaces before not too long.

In a similar vein, even five years ago this sort of activism about clinical research would have seemed impossible – desirable but impossible. But now it’s here.  And it’s where it should be – with and alongside the communities it seeks to serve.

Have a great day.

Today sees the annual Cancer Patient Experience Survey published.

For the third year running it looks at the extent to which people with cancer are being told about the opportunity to take part in research. Also, how many take up that opportunity. National data is published and then statistics are provided by NHS Trust and tumour type.

The results are not that encouraging. Since the survey started including questions about research, the dial has been stuck at less than 1 in 3 people having that possibly life-saving conversation with their doctor. If anything there is a slight trend downwards  In 2012 it was 33%, inn 2013 it was 32% and 2014, 31% (see pages 61 onwards of the report).  If you have brain or haematological cancer the figure is 37%. If you have skin or urological cancer it’s 17% and 14% respectively.

I am sure some people would say the drift downward is a statistically insignificant drop. But consider this.

For arguments sake, say cancer research is a business. And say patients with cancer are its customers. Then in business terminology we would be informing the stock market that sales are flat, the growth forecast is poor, and there may be a case for issuing a profits warning. And we all know what has happened to even our biggest companies like Tesco when this happens.

What are the causes for this lack of ‘growth’ in the numbers of people with cancer being offered the opportunity to be part of a clinical trial? Why is this happening in a clinical area which had had the longest run-up at promoting research to patients?

I don’t know for sure, is the answer. But I hope that it is an agenda item at the next board meeting of the National Cancer Research Institute (NCRI). Finding out why and putting in measures for improvement will be important.
Arguably, for instance, the cancer patient experience survey should be one of its performance measures. Personally I would like to see us aim for results nearer 50% and 80% by 2016 and 2019 respectively. Arbitrary perhaps but we need to be aiming for something.

I do have an opinion as to what’s not happening. It may be wrong. Nor is it likely to be the whole picture. But it’s based on conversations with public involvement colleagues in cancer and others around the country over recent months.

I think our consumer groups in cancer are not being listened to as much as they should be. I think ‘change’ may be drawing them away from the business at hand. I think that they are not being given the funding and support necessary to be what they can be – an important part of the ‘sales force’ that delivers on the NHS Constitution pledge that every patient has a right to information about research. Finally, I think we are failing to engage their colleagues in the NHS workforce sufficiently in this agenda. But that goes for all conditions.

If I were invited to that next NCRI Board Meeting I would be encouraging them to look at NIHR’s strategic framework for increasing participation in research ‘Promoting a research active nation.’ It doesn’t hold all the answers. However, I would be suggesting they look at how to translate its clear and considered approach – from the research ambassadors programme to the ‘OK to ask’ campaign – to cancer. And then to back it strongly.

There are some reasons to be optimistic. The members of the NCRI Consumer Liaison Group are a formidable force and well-led. Our cancer researchers and clinicians are committed. Cancer Research UK now has a public engagement strategy, budget and team in place and will be putting more weight behind this agenda in the next 12 months. Let’s hope other cancer charities follow suit.

For this results is not good enough for people with cancer and their families.