Researched changed my life (and apparently a lot of other people’s too!)

Image Ever cry at work?  I don’t mean with the sheer stress and frustration of it all (stress?  in the NHS? NO I hear you cry!), but because something just gets you.  Well, the guy in the picture is Marc de Block, and he made me shed a few tears.  Before you accuse him of being an utter rotter, it’s in a good way! 

Marc (and a massive thank you to him, and all the other patients that I don’t have enough room to mention) is one of the 630,00 or so NHS patients who are participating in clinical research, and he shared his experience of doing so as part of our “Research Changed My Life” campaign to raise awareness of clinical trials, the different motivations for taking part, and what difference it can make when you do.   Marc was diagnosed with multiple sclerosis seven years ago, and started on a study four years ago.  Before he was on the trial he suffered periods when he couldn’t see, couldn’t walk.  That doesn’t happen any more.  But the bit that got me was when he talked about his four-year-old daughter, who, he said, doesn’t know that there is anything wrong with Daddy.  He said clinical research gave him “normal” back, when his life had been significantly far from normal because of his condition.  

I guess the reason Marc’s story struck a chord, is because I knew someone with MS.  Like Marc, he had periods when his sight and mobility failed, but he was not a person who wasted time feeling sorry for himself.  For the campaign Marc was filmed playing golf – a hobby he started to put one finger up to his illness – and the person I knew was just the same.  No matter what the MS threw at him (and despite the fact that he was never offered the chance to go on a clinical research study that might have helped) he refused to let it get in the way of what he wanted to do in his life.  He resolutely stayed himself.

The more patient stories I hear, the more I’m struck by the relationship between clinical research and self-identity.  When we’re ill, it’s very easy to feel powerless.  To feel at the mercy of our illness – a victim even.  So for some patients, taking part in a clinical research study isn’t about “getting cured” (although that would be nice, obviously, doctor!).  It’s about doing something positive.  Something that helps you to understand your condition better.  Something that gives you some control over what’s happening, and that puts you on a different – more equal – footing with your medical advisers.  One patient who took part in a video about his research journey said that being in a clinical trial “gave me myself back”.  I don’t think you can say it better than that.

Anyway, check out the stories on Research Changed My Life.  If they don’t make you cry, they’ll make you think.  Hopefully about the brave, hopeful, bloody-minded, scared, curious, tenacious and selfless people who take part in clinical trials.  They might do it to be normal, but there’s nothing normal about what they do.  

Does anybody care.data?

data security Pending a cure for cancer, it isn’t often that clinical research gets on the front page of our national newspapers.  But – by association – it has done so this week, in the form of great big 80 point headlines about care.data and the dire threat it poses to patient-kind.

In case you missed it (could you miss it?) care.data is an attempt to join-up all the sources of patient data in the NHS so that it can be used to inform decisions about healthcare and – potentially – be used for the purposes of clinical research.  The data itself is anonymized.  Well, actually it is “pseudonomised”, which is a distinction that only a hardened technie could care about.  To the rest of us it means our identity is protected.  The core objections to care.data in the media coverage seem to be around the threat to privacy and confidentiality if anonymous data is shared (it’s ANONYMOUS, come again?) and the fact that people have been kept in the dark about care.data’s development and it seems to have sprung out of nowhere to be foisted on an unsuspecting  public against their knowledge.

Just to be clear, care.data is not an intiative that the National Institute for Health Research Clinical Research Network has anything to do with.  But of course, because this stitching together of data-sources could be used for clinical research, we are keeping an eye.  And we ARE involved in a different but similar thing called Clinical Practice Research Datalink, so I have been watching the furore in the press about patient confidentiality and security with a kind of horrified fascination.  If the general public is turned against care.data, this attitude could transfer to any “big data” system that uses anonymous patient information for clinical research purposes.  That would be a pitiful waste, when the UK is on the brink of being right at the forefront of developments in this area.  Developments, let’s remember, that could lead to new and better treatments for you and me.

There are a few things that strike me about the whole care.data shock-horror response. 

One thing is why it has taken until now for the media to get the plot.  When the NHS Constitution was last renewed in March 2013, one of the alterations included the insertion of a new pledge to “anonymise the information collected during the course of your treatment and use it to support research and improve care for others.”   Phew I thought.  That’s a short statement with big ramifications.  Wait for the debate about privacy etc. and the mass wagging of fingers from Caldicott Guardians across the nation.  Never came.  In fact, I remember speaking to a national journalist  and asking him (in a vague, just-kinda-interested sort of way)  if he was picking up anything around the new Constitution.  Not a jot was the answer.  Yet here we are, nearly a year on from that moment, and the press have suddenly decided this is BIG and NEW.  Not really guys, you just missed it the first time.

 

Some of the journalism on the debate has been pretty shoddy.  I listened to a Radio 4 programme (yes, the channel that likes to think of itself as responsible and intelligent) where the interviewer somehow failed to mention that the data care.data will provide is actually anonomous.  Maybe just me, but I thought that was a bit of a crucial point?  They were in good company.  The Daily Telegraph’s coverage quoted someone from an organisation called Big Brother Watch.  Hmmm.  No particular agenda going on there then.

Another thing that strikes me about all this, is that the fear factor isn’t really about data – it’s more about technology.  If we go into hospital we’re perfectly happy to have paper medical notes passed around from person to person without question, the assumption being that it is fine.  But put the sharing of data into the domain of technology, and all of a sudden it’s a scary proposition.  Apparently.  I say apparently because increasing numbers of people are choosing to share their health data – attributable and unanonymized – on various health-related websites.  So obviously not everyone is that panicked.

This is not to say that the whole care.data thing has been handled well.  It hasn’t.  The concern that people have been kept in the dark is, I think, fully justified.  I say that as a citizen who didn’t get “the leaflet” through my door, telling me that my data was going to be used to maybe help save my life sometime.   As a communications professional, I feel a bit of sang froid about this.  My experience of the health sector has – all too often – been that everyone says communication is ultra important, but then doesn’t devote any attention to actually doing it properly.  Did NHS England REALLY think that a paltry leaflet, delivered alongside the mailers to transfer my credit card balance and get a pizza margherita couriered straight to the door, would be enough to convince the nation that “the man” is working in their best interests?  Considering NHS England’s National Director for Patients and Information is a former journalist, we might have expected a bit more focus on the public’s right to know.  Or perhaps the enthusiasm for new technology (and people do get VERY excited about it in the health sector) overcame common sense.  Maybe there are a few movers and shakers who need to be reminded that as well as the people who can’t wait to volunteer their entire medical history online (yes, they are out there) there’s a big chunk of the general public whose experience of the technosphere is more “computer says no” than “big data saves the world”.  They need to be informed and reassured.   Not just once (with a leaflet that maybe never came, from an organisation they still neither know nor understand) but lots of times, in lots of ways, by people they trust.

I think what care.data showed in the end, is that there is plenty of interest nowadays in what data can be provided BY the public (to help businesses, public institutions, charities etc to do their job or make a buck), but not enough care about what data should be given TO the public (about the things that are done using their taxes, in their name).  I don’t agree with most of the journalists covering the care.data story that use of anonymous (just want to say that again:  an-on-y-mous) details to improve health services is per se a bad thing.  But I do agree that from a public information perspective, this was a distinctly UNhealthy project.

Is clinical research worth the effort?

Maybe it’s just me, but sometimes you wake up in the morning, look at the long list of the things you have to do, and the meetings you have to go to, and you think, “does it all really matter?”  All these studies, all this information, all this effort to make clinical research count;  is it worth it?

Well, today I have an answer to these questions.

This morning the NIHR Clinical Research Network published researchedchangedmylife.com a website of stories by patients, sharing their experiences of taking part in clinical research and what it has meant to them.

For some it has meant a chance to understand (and cope with) their health condition better.  For others it has meant regaining a sense of who they are – feeling like a person, with choices and with some control, instead of a “patient” – perhaps even a ‘victim’ of circumstance.  And for a few, it has meant the difference between life – a life worth living – and death.

So next time you’re having a “down” moment, have a read of these stories.  Then pick yourself up and get on with it, in the knowledge that everything we do to bring clinical research opportunities within reach of patients is worth it.  Every  single bit.

Often – and especially in research – it is the clinician’s voice that we are used to hearing.  But in reading http://www.researchchangedmylife.com I was struck by how powerful it is to hear patients tell their own stories, and just how amazing people can be.  So “thank you” to all the patients and carers – those hundreds of thousands of people who take a difficult time in their own lives and turn it into something positive for everyone.

The bloke in the wig? Yeah, it’s James Lind…

lind_jamesYou can find yourself doing funny things sometimes in this job.  

True, there are days when it is all serious “big girls” meetings to do with improving the time it takes to start up a life-sciences industry clinical trial in the UK (a refreshingly swift 55 days on average now, since you ask).

Then there are the other days, when you’re tracking down a frock coat and a wig for an actor who will play Dr James Lind (the chap who invented clinical trials back in the 1700s) as part of your slot at the British Science Festival, designing a “wheel of scurvey” prop (please, don’t ask about THAT one, you’ll have to see it for yourself) or judging the competition for a public online clinical trial to be run during the Festival event to help people understand a bit about trials and the concept of randomization.

Yep, it is the NIHR’s very first appearance at British Science Festival, so please come and support us.  Tickets are FREE, it’s open to the general public as well as researchy types and it’s on Thursday 12 September between 4-5.30pm on Stage 2 at Northern Stage in Newcastle on Tyne.  The link is here.

http://www.britishscienceassociation.org/british-science-festival/bench-bedside-how-clinical-research-making-waves-patient-care

If you’re wondering what our show will be like, it’s kind of top boffin meets the Edinburgh Festival, with a healthy dose of Bang Goes the Theory and a slight smattering of Theatre of the Absurd (quite possibly).  The Profs and Docs really know their stuff and are definitely worth seeing, but it’s a tiny bit scary as we only get one rehearsal before we’re live.  But hey.  It’s in Newcastle and Geordies have a sense of humour.  (I can say that, I am one). 

One thing we are doing is running a live clinical trial in the audience (and online during the Festival itself).  It’s called the COMET trial (Conversation OR Music and Effect on reaction Time) and should be great fun.  Come and join us or have a go at home with your kids.  The trial is on the website link above.

It’s OK to ask…

OKtoASK blueOK, so you’re all hard-hitting, high-flying go-getters out there reading this blog. But faced with illness, and a doctor in a white coat, you probably do what most of us do – which is, what you’re told by your clinician. Of course that’s right (it is what we have experts for), but is it enough?

When it comes to clinical research, the answer is “yes and no”. On the “yes” side it is true that the number of people going into clinical studies in the NHS has massively increased in recent years. (Pat yourselves on the back NIHR Clinical Research Network research nurses for helping to bring clinical research opportunities to more than 630,000 NHS patients last year). That means you stand more of a chance of being asked if you’d like to take part in a trial that could give you earlier access to potentially life-saving new treatments than ever before. Of course, that still depends on what condition you have to some extent, as some therapy areas (cancer for instance) have better developed routes into clinical research, and more studies going on across the country.

On the “no” side, there is the question about, “what happens if my doctor isn’t that interested in clinical research, and DOESN’T decide to tell me what trials are happening that might be relevant to me?” This is – unfortunately – still sometimes the case. And because we’re conditioned to rely on our experts, and do what they tell us, we patients miss out on opportunities that could help us, and could help others.

It was with all this in mind that we launched “It’s OK to Ask” this year – a campaign to encourage patients to take the initiative, and ask their doctors whether research is right for them. Personally, I hate the word “empowerment” because it’s HR twoddle. But I don’t hate the idea. I’d like to think that good doctors and nurses would be happy for me to take an interest in my own care, and would want me, as a patient, to ask about all the options available to me.

This is where I show my sad TV habits, but I remember watching an episode of ER ages ago (yeah, what happened to THAT?) where Dr Mark Green got terminally ill and was told there was nothing could be done. In the story, his wife found out about a clinical trial, which actually helped him to rally. I didn’t work in clinical trials back then, but I remember thinking at the time, “Why the hell hadn’t anyone told him about the trial? How come his wife had to do the research and set it up? Surely this is just fiction – it can’t happen in real life?”

The pity is, it can and it does. And if by running a campaign we can encourage one (or ten, or ten thousand) patients to ask their doctor about clinical research and get a more effective treatment more quickly, I think that’s worthwhile. Yes, it will rattle the cages of those (mercifully few) clinicians who want to keep the old paternalistic attitude to care in place, but so what? Maybe those cages need some rattling.

If you’re interested in OK to Ask, read about it here: http://www.crncc.nihr.ac.uk/oktoask

NHS mystery shopper campaign is no longer a mystery

Teeside University HospitalThis week, we published the results of our “mystery shopper” initiative, which involved sending patients into 40 NHS Trusts, to see how easy it was to find out about local clinical research activity, and opportunities to participate in studies.

Considering 99% of all NHS Trusts are doing some level of clinical research  (our clinical research nurses deserve a hearty pat on the back for that!), AND the fact that promoting clinical research is one of the principles of the NHS Constitution, you’d be forgiven for thinking the results wouldn’t be that bad, right?

Wrong. 

91% of the hospitals we visited had nothing about clinical research available to patients, in all the obvious places you’d expect a patient to look.  I’m talking about leaflet stands, noticeboards, waiting room areas, receptions, patient info screens and the like.  Worse still, the “front line” of receptionists and Patient Advice and Liaison Service staff mostly didn’t know where to signpost our persistent mystery shoppers.  You can’t really blame them for that – how do you keep tabs on everything that happens in an NHS Trust? – but it does need to be addressed.

The irksome thing is that there are materials out there that Trusts could use, to help patients to gain a better understanding of clinical research, so that a patient feels well enough informed to be able to ask their doctor about research participation.  At the moment, most patients have no other option but to wait for their doctor to initiate the conversation – if indeed they ever do – which can’t be great for patient choice.  

(For the record, for anyone who just wants a general primer, I’d point them towards Understanding Clinical Trials, Clinical Trials: what they are, and what they’re not, and Your health records save lives.   If you want a bit more, then visit the NIHR Clinical Research Network website patient page.)

In a few weeks we’re going to produce a pack for NHS Trusts, which lists the resources we know about that could help them to raise awareness about clinical research.  Meanwhile, if you are a patient, or a clinician, I challenge you to our mystery shopper test.  Take our survey into your own hospital or surgery, and see clinical research accessibility through a patient’s eyes.  If you do, I’d love you to Tweet @NIHRCRN to let me know how you got on, or add a comment here. 

NHS Trusts have done a fantastic job in doubling the number of patients that take part in clinical research over the past five years (more than 595,000 last year alone).  It’s time we moved it on to the next stage, and made research activity visible in our hospitals and doctor’s surgeries, so patients are aware that research happens, and can talk to their clinicians about it, if they want to do so.   Clinical research opportunities for NHS patients – now there’s a mystery worth solving…

A tragic exception that proves the rule

Much of what you’ll read in my blog is – understandably, given I work for the research delivery arm of the NHS – very “pro” clinical research, because it is the best way we can gather the evidence to improve patient care.  But in this post I wanted to acknowledge there can be another side to the story.

In 2006, a cancer patient tragically died as a result of side effects from a clinical trial.  His family has now received a six-figure settlement, which in no way will compensate for their loss.

Any death is poignant, but somehow it is significantly more so when it occurs as a result of an intervention that was supposed to alleviate suffering, and that will no doubt have carried the hopes of the patient with it.   The report I read about this particular case said that trial protocols had not been followed, and that important check-ups had not been conducted as they should have been.  If these had occurred, the patient might have survived.

Talking about such things is difficult, because no-one wants to minimize such a tragedy, or dismiss the pain caused to this patient’s family.  But it did give me cause to reflect on the issue of risk in connection with clinical research participation.

What struck me about this incident was that it is so rare.  We very seldom read about clinical trials that go awry, for the simple reason that it so very rarely does.   Last year I did some research into the number of clinical research claims that the NHS Litigation Authority had dealt over the past five years.   I found that of the 57,065 clinical claims that had passed through the Authority between 1995 to 2010, only six had been related to clinical trials.  Of these six claims, three were rejected, one was ongoing, and two had received payment (a total of £160,000 plus costs between them).  When you consider that the total amount paid in damages for NON-research clinical claims amounted to more than £8,660,644,000, it is an astonishingly low proportion.

Causing harm to a patient is absolutely unacceptable, and no right-minded person would say otherwise, but I am arguing for a sense of perspective and balance.  There will be those who read the same article as I did in the BMJ, and call for more regulation, or perhaps even fewer clinical trials.  In my view, this would be a mistake.  All medical interventions carry a level of risk – including clinical research studies.  However, the fact that the BMJ carried this story at all was because it was an exception.  A terrible exception, certainly, and one we should definitely learn from.  But not one that should make us question our commitment to delivering clinical research in the NHS.

Don’t tell the patients we do trials – they’ll all want one…

You get to hear lots of uplifting stories about clinical research, and meet some very inspiring people, but just occasionally you come across something that just puts a downer on your day.

One such experience I had recently was talking to some communications leaders from NHS land.  All highly competent professionals, working in complex organisations, often witihin considerable budget constraints.  Nonetheless, given the milieu in which they work, one could be forgiven for thinking that they would be pretty “on board” with things that impact positively on patient choice, improvements to treatments, and responding to what patients say they value – clinical research opportunities, in other words.

So it did surprise me to hear that these communications people don’t see it as their job to make patients aware of the clinical research agenda.  In fact, they actively don’t want to draw attention to research in case it actually might stimulate demand, and cause more patients to ask for opportunities to participate in clinical trials.  And if THAT happens, NHS Trusts might have to respond by making sure they do actually engage in clinical research across all therapy areas, and not just the “biggies” like cancer.  

I had rather assumed that was exactly the point, but clearly that is not a view that is universally shared.  Of course I understand there is reputation risk in creating a demand you really can’t service, but is that an excuse to do absolutely nothing?  Makes me even more determined to publish the results of our “mystery shopper” campaign in the New Year, where we expose exactly who is promoting research opportunities to patients (as the NHS Constitution says all Trusts should do) and – perhaps more importantly – who isn’t.   A national newspaper has already indicated it is interested in the results of this exercise, so perhaps that will convince the doubters that they should think again about making research opportunities actually visible to patients.

Research results – public property?

There’s been an interesting debate brewing in the pages of the British Medical Journal over recent weeks about the need for commercial life-sciences companies to make their research data publicly available, so that others can learn from their findings.

The position of the BMJ (or certainly its editor Fiona Godlee) is that research data should be open for independent scrutiny once a regulatory decision has been made, and she is not alone.  The doctor and blogger Ben Goldacre  has written a whole book on the subject, which also features on TED.

Here at the National Institute for Health Research Clinical Research Network (I know, long name;  just think what it’s like having to type it in everything you do!)  we are also joining the debate.  Our CEO, Dr Jonathan Sheffield has just written a piece for Public Service: Health and Medicine, calling for all researchers (commercial and academic) to be more transparent in publishing their results.  His reasoning is that NHS patients volunteer to take part in clinical trials – for altrustic reasons – because they want to contribute to our understanding of disease, help doctors to tackle health issues and improve treatments for others like themselves.  There is an expectation that people are contributing their time and data  for the public good – which carries a responsibility for public accessibility of results.  If we don’t publish, how are we going to avoid needless duplication of effort or, worse, wasting scarce time and resources on clinical “dead-ends”?

This issue becomes even more resonant as government looks to “open up” NHS databases for interrogation by researchers (albeit in anonymised form), which is why we have made it the topic of our next online Q&A on The Guardian. 

If you want to take part, go to the Q&A link above between 12 and 2pm on 6 December 2012.  You can read what people are saying, or add comments yourself if you’d like to join the debate.  To take part you do need to register on The Guardian site first, but this is quick (and free).

And the winner is…. Southampton!

Not often that you get to go to swish hotels on Park Lane in these stringent times, but that’s exactly what we did in November to celebrate the Health Service Journal awards – and cheer the winner of the award we sponsor for Clinical Research Culture in the NHS.

Given that conducting clinical research is supposed to be part of the day job for NHS Trusts, it might seem strange to be sponsoring an award in this area, but the truth is that research is still not fully embedded across every therapy area in the NHS – despite the fact that it features in the NHS Constitution.  The award we sponsor is to try to recognise those Trusts that are trying to address this issue.

So the burning question is:  who got to take the trophy?   I’m delighted to say it was Southampton University Hospitals Trust – and very worthy winners they are too.  What’s impressive is the way that they’ve made research core business, byputting it on the “to do” list of all their consultants.  In practice this means that when they make a senior medical appointment, that appointee is charged with coming up with a development plan for their section that includes clinical research.  They do lots of other good things too of course, particularly in relation to the training and development of research nurses, who are the “engine room” for research delivery in the NHS, and sometimes criminally under-valued.

Some cynics might say, well it isn’t that surprising that a University Hospital should win this award, and it is true that university hospitals start a little further down the line.   But what was striking about Southampton was that many of the initiatives could in fact be adopted by district general hospitals and others.  With that in mind we’re going to try to capture some of their good ideas through a video interview and “top tips” sheet, which we’ll share on The Guardian Clinical Research Zone when they’re ready.  Meanwhile you can see the photo of the winners, as they fly the flag for research in the NHS.