Clinical trial

The Chief Medical Officer, Professor Dame Sally Davies, published her annual report today.

Actually, it’s two reports. The first is the usual state of the nation summary of the population’s coughs and splutters. The second, uniquely this year, looks in depth at the worrying lack of attention we have paid to young people’s health. It’s entitled ‘Children Deserve Better.’

You have probably caught some of the news reports about this already. These have focused on things like the re-emergence of ricketts, and the high mortality rate among children in our country when compared to places such as Sweden.

One of the benefits of the nation’s doctor also holding the role of being the nation’s chief clinical researcher (Director of R&D at the Department of Health) is that in her deed and word, the bedside is never too far from the bench, and vice versa. We must make the most of it while it lasts.

So, in the report on children and young people’s health I am delighted to see that Dame Sally has followed up on her comments and highly vocal commitment at the recent Generation R event in September (see previous blogs) by including the following recommendation:

Recommendation 23:
The National Institute for Health Research (NIHR) Clinical Research Network, including the NIHR Medicines for Children Network, should work with children and young people to input to the design of clinical studies in order to facilitate increased participation of children and young people in drug and other trials.

That’s a clear steer to me and others across NIHR and elsewhere to make this happen. I know personally how much Dame Sally is interested in this area, simply by her frequent nudges to me to make sure young people are part of NIHR’s strategy and plans for public involvement and their wider access to research.

Speaking as a pseudo policy-maker the key now is not for us to receive a myriad questions by email but solutions and ideas on how we can achieve this on a larger scale than we have already managed.

For we start from a good base in the UK when it comes to involving young people in research. The model we have adopted in the Medicines for Children Research Network is feted and being copied by many abroad (Canada for one). But there is much more we can and should be doing.

Children deserve better.

Not for the first time I was awake at 3am this morning. Cup of tea in hand, watching American football.  It’s amazing how those players keep the ball when so many other players are piling on top of them.  Rarely do you see the thing break free.  They must practice for hours….

The House of Commons Science and Technology Select Committee has this morning published the report of its inquiry into clinical trials .

The overall thrust of the report and its recommendations has been welcomed by those who have been calling for greater transparency in this area.  Not least the ‘AllTrials’ coalition who have spearheaded this campaign and whose public petition is approaching 60,000 signatures (see link at foot of this page if you wish to sign).

Those on the other side of the debate have been somewhat quieter.  I wonder whether this reflects their sense that they have got off more lightly than might have been expected when the inquiry was launched in 2012.  It could mean the reverse of course.  But, from my perspective, I would make three observations.

  • It is a shame that this inquiry – which is at the end of the day about research largely involving patients and aimed at improving people’s health  – was not steered by the Health Select Committee or had some involvement from them perhaps in a joint session.  It means we have a report that is fundamentally about the scientific process.  Debate about such processes and their complexities are a safe haven for funders who like to say: ‘You wouldn’t understand’ just a bit too often for my liking. It is true that the report clearly references the importance of transparency to patient safety.  But I would like to have seen more exploration of the first principles for why we do this sort of research in the first place.
  • Also, despite receiving written and oral evidence on the subject, the Committee did not  acknowledge or recognise the importance of involving the public in trial design and delivery.  This partnership can help to address some of the issues around ethics and process that  professional colleagues struggle with.  It does not even recommend a wider dialogue with patients and the public about how some of these challenges might be overcome.  Which is odd given the increasing numbers of people going into trails and the importance of the public confidence factor in sustaining the clinical research sector going forwards.
  • So, as a result, the report does not address the transparency issue sufficiently from a patient perspective in my view.  I am disappointed that the Committee does not recommend all research participants should be informed about the results of a trial they have taken part in.  Or embrace some of the questions Ben Goldacre encourages patients to ask in his book ‘Bad Pharma.’ Nor does it consider how access to clinical trial data might actually be a powerful tool for patients in the future in understanding and making decisions about their own individual care and treatment.  We really do need to pull the debate away from the limitations and faults of the current system to a consideration of future possibilities.
  • Lastly, I am fascinated that the Committee aims the vast majority of its recommendations and some of its heaviest criticism at Government.  Funny how the health research ecosystem that funders love to champion going into a spending review, breaks down when there might be a suggestion of them taking on greater liabilities and responsibilities.  Yes, Government sets the regulatory framework.  But funders should be doing this because it is the right thing to do.  The Committee, in my personal opinion, should have said this more strongly; after all Andrew Witty from GSK was happy to say so many months ago. Fundamentally, the Committee could and should have placed greater responsibility at the door of industry and charities for both a) laying down requirements around transparency with those they fund and have funded for the last umpteen decades and b) monitoring compliance.  Neither sector in the whole is short of money to do this.

Yes, for these reasons, the ball skidded away on the wet grass for me.

And sorry, I think it laughable that any company or science establishment is still in business who has bothered to give evidence to a Committee but claims not to have heard of the Health Research Authority (HRA).  They are clearly not paying their public affairs consultancy nearly enough.

On the positive side, I am delighted that the Committee signals its strong support for efforts to encourage more people to participate in clinical research including ‘Ok to Ask,’ and to strengthen and improve the UK Clinical Trials Gateway (UKCTG).  It also comes up with some helpful and challenging critique for how both might be done.  The committee discusses these aspects on pages 23-29 of its report.  Somewhere in the appendix you can find a transcript of my oral evidence.

And a reminder that the writings on this blog, are as always, a personal view……

You didn’t think I’d forget NIHR Friday did you?

So the National Institute for Health Research Clinical Research Networks Co-ordinating Centre (NIHR CRN CC), together with The Guardian online, has this week published its annual performance tables for research activity in each NHS Trust in England for 2012/13.

You can find the figures for your local NHS Trust here. For each Trust data is provided on the number of clinical research studies recruiting during the year, along with the overall number of patients recruited into all studies.  Comparative figures are provided for 2011/12 so you can see whether activity has increased or not where you live.

Overall the news is very good indeed.  More than 630,000 people were recruited into clinical research studies.  That’s a 7% increase on the year before.  During the year NIHR CRN supported more than 4,200 studies and that’s a 12% increase on 2011/12.  There are some nice, simple summary reports available through the NIHR CRN CC website here (look for the pdfs at the end of the page).

A good year then.  But it can get better.  Hence the importance of the ‘Ok to ask’ International Clinical Trials Day (ICTD) campaign this year.

This week I was fortunate to see the early feedback and results from the campaign (in fact some of them are in my Leeds presentation which I posted yesterday).  There is much to celebrate.  You can be sure we will be continuing with the theme and perhaps we need to join-up the performance stats and the ‘Ok to ask’ activity in some way?  How about a ‘Rapid Reaction Ok to Ask’ taskforce to focus on the areas where we need to do most work?

Have a good weekend.

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There was a story in The Times (pay wall) yesterday about the successful campaign being run through Facebook in the US to get people to become organ donors. Thousands of people have responded to the message passed from friend to friend. Similar success has been had in the UK. My Citizens I can tell you that, quite literally, many of us are giving it passing thought and saying ‘yes.’

I was drawn to this story because, at the conferences I have attended over the last week, there has been an active discussion about how patients are asked to give consent to take part in clinical research. It has left me wondering not just ‘what it is for’ but ‘who is it for?’

We seem to have developed the most cumbersome process for codifying a very human, perhaps one could even argue humane, act. An act that many of us are more than willing to make I should add.

Listening to patients and clinicians these past few days has strengthened my view that they both feel the hand of others on their shoulders at the point of giving/taking consent. And I’m not talking about history or a higher being. No, it’s lawyers, managers and others they sense breathing down their necks (actually one of the above categories does think its God come to think of it).

The main ‘instrument of perversion’ – as I like to now call it – is the consent form. Often long and just as often convoluted it flies in the face of all the evidence about how people best absorb Information and build understanding. Nor does it mirror our changing life experience for how we give consent in other contexts. For many patients and their relatives I am sure it must feel like an out-of-body experience but without the light at the end of the tunnel – no wonder it is cited by people as a barrier to participation.  Yes, it is a blunt instrument indeed.

As important as the dreaded or should I say dastardly form, is who is involved in the conversation on the professional side. Often the rules do not allow it to be the person with whom a patient has – or will have – a close relationship with during the research. I know this is a common gripe of clinical research nurses whose role in partnering patients in research seems completely underplayed and under-valued.  That just doesn’t seem right or even practical and stands as another barrier in itself to recruiting people to research.

Then there is the fact that we seem to approach consent as a one-off moment of decision-making into which we try to cram as much as possible. To put it another way, we are trying to do too much in one go. It can not – in fact I know it does not – lead to a good understanding in many patients about what is going to happen, the risks and benefits. (See the work cited elsewhere on this blog about people’s understanding around placebo for instance).

So what to do?

When I asked my wife what would help her to give her consent to take part in a trial she said: ‘I would like to know what I want to know’ and talked about having a framework which helped her to prioritise information according to her needs and questions and interrogate it in her own way and under her own steam.

Thankfully this participant-led approach is something others are beginning to develop. From the use of online consent in bedside tablets (as I heard in Oxford), to DVDs and videos (PATH Biobank in Germany) or the redesign of forms and accompanying literature to include flow-charts and visuals etc. Others are trying a more deliberative approach with patients which occurs over a longer period of time.

As an aside, in India – where the conduct of clinical trials is being reformed to stop the continued abuse of participants by pharma and their contract organisations – they plan to cope with low literacy levels in the population by taking consent on video. Well, why not here?

A job for the Health Research Authority (HRA)? Actually, there’s no reason why we as patients could not or indeed should not come together in an innovatorium to radically redesign the consent process, develop models and campaign for national adoption.

All I know is that the current system is creaking and needs to change before it croaks it.

What do you think?

It was so humid when I stepped onto the sidewalk it felt like I was treading water. A threat of storms hung in the air, battleship colour clouds steaming slowly across the horizon. Far from here but menacing nonetheless.  An occasional spot of rain found its way on to the floor; a steady hum of a/c units was never far away- contented hives.

Taxis cleared their throats like Uncle Sam on his porch as they lumbered away from the side-walk. An occasional police car whooped its siren to move along a throng of other waiting cars. Porters hovered – there is always someone ready to help you in the US.

I had forgotten what it was like to arrive in an American city in the summer. How every sense is conquered.

Looking up I saw the signs asking us to join American Airlines in supporting the American Cancer Society in its 100th anniversary year. I remembered the interview in the in-flight magazine – between the CEOs of the two organisations.  It had a strong message of hope for cancer patients; particularly the graphic showing the percentage of people surfing cancer compared to 30 years ago. Research was key they said. But at the same time I couldn’t help ruminate how like business major charities and foundations have become in their ‘speak.’

As I sat in the back of the cab, Prince’s 1999 gave way to adverts on the radio. The first called for young male volunteers for a clinical trial being run at the hospital; reimbursement was possible it said. But, in reality, in tone and style it sounded no different to the next which was announcing a bargain sale if sofas. Or the next, advertising places at the local school. The cabbie himself had a small sign on his back seat asking us to support diabetes research? I saw a girl playing in the street and wondered if he had a daughter with diabetes and that’s why he was asking. I should have mentioned it.

Billboards and advertising hoardings buffeted and stretched for mile upon mile like one of their great freight trains. On each Freephone numbers spell out what they will say to you say on the phone. So an injury claims company’s number to call is: 1-800-HURT. I love that.

As the freeway rose on stilts heading into downtown, it curved around the new university hospital complex. ‘Health Sciences Centre’ said the sign on one of the tallest buildings and in letters the size of a small house.

Here’s a country not shy of talking about its science I thought.

The Cystic Fibrosis (CF) Trust launched its new five-year research strategy in London yesterday.  I have to say I am highly impressed.  In terms of content and dissemination they seem to have single-handedly shown the rest of the medical research charity sector how to embrace the future as a funder and a patient group.

Why is it so good?  Well, the research strategy is clear and visionary.  It seems to strike the right balance between basic research and clinical research.  But it’s more than that for me.  Most important is the firm commitment to ‘Enhancing the involvement of people with cystic fibrosis in shaping research’  as one of its three enabling piorities.  I also like their very simple but effective ‘SCORE’  approach to evaluating potential research ideas to fund. It’s about time more charities came out with similar focus and simple creativity.

I’m also pleased that CF Trust’s new approach to research is available to a wider audience using Cystic Fibrosis Unite among other devices. As I found out after I did the first (perhaps exciteable!) version of this blog CFUnite is independent of the CF Trust and funded by a Wellcome Trust People Award. But my excitement is not totally unfounded.

I love the fact that CF Unite embraces and pulls in all possible partners in making research happen – you really do want to be part of the enterprise.  On the CFUnite site you can register your interest to help design and take part in clinical studies.  And you can email them if you want to find out the results of relevant trials.  This is just the sort of thing we should be doing in the name of transparency and in the public interest.  You can find all these features here.

CF Trust complements this with its own cross-referencing and linking to CF Unite but also by giving people information on clinical trials taking place in the UK.  This is a facility that it has made available for some time and shows its long-term commitment to making sure this sort of information is in the public domain.

Its a worthy package that has made my day.