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‘Scroll down’ for clinical trials

To begin with, here’s more on that Pfizer story about use of mobile phone technology etc in clinical trials. It seems to have piqued an interest among many of you anyway.

Also on the subject of clinical trials, I was rather perplexed by this story running out of the NHS Confederation this morning. I’m delighted that the NHS Confederation are at last exercising their PR might in the name of research – it must have something to do with Mike Farrer’s move there as CEO. As you may know, he was previously the chief executive at the North West Strategic Health Authority which led the hallowed ‘NW Exemplar work on clinical trials.

The overall message of the piece about regulation standing in the way of clinical trials is also good. But I am sure the data/evidence they have put forward to support it, passed its sell-by-date a long time ago. If you look at the latest metrics for trials put out by the NIHR Clinical Research Network (CRN) Co-ordinating Centre, one gets an alternative and more up-to-date picture of an improving situation.

Much work is still to be done though.

The really striking bit in yesterday’s MORI survey by the Association of Medical Research Charities (AMRC) was that showing the degree to which patients would be willing to assist in research by participating in trials (72%) or letting researchers access their confidential records (80%). But you have to scroll down the page to see these results.

A bit like we expect patients to ask their GPs to do if they want to turn their willingness to take part in research into action. I am sure I saw an academic paper a few weeks ago which heralded the 39% or equivalent GP practices that were active in recruiting patients for trials in Eastern England. All I could think of was…what about those people living in the catchment areas of the other 61%. Perhaps their GPs still use scrolls instead of prescriptions.

So grist to our mill in making sure the Health and Social Care Bill supports the things that are already being done by NIHR and others to change this.

mICRA, PROSPERO, Beddington and Bell

Announcements are like buses.  There are none for what seem like days and then several come all at once.  My job is to make sure you get on the right one…

NIHR has several announcements out today which AMRC and its members have had some involvement or interest in.  The first is the launch of the new model Industry Collaborative Research Agreement (mICRA).  It will enable research studies to start much more quickly by enabling people to work through the contractual issues more efficiently, particularly issues around Intellectual Property (IP).   AMRC was on the working group that developed it.

I see no reason why the document should not be as reliable, solid, or user-friendly as its automobile namesake, the Nissan Micra, but a lot faster!  And if you can tell me what the link is between that car and a well-known UK charity that is an AMRC member charity you can have a free invite to our Science Communication Award ceremony in March.  

The second announcement of note is the launch of PROSPERO.  Developed by the NIHR’s Centre for Reviews and Dissemination, PROSPERO is the first online facility to register systematic reviewes for research about health and social care from all around the world.  And access is free and open to the public.  An excellent tool in the drive towards greater transparency and the curtailment of duplication.

And if you’re up for a good debate in this half-term week then my favourite blog of the moment is Alice Bell’s on the recent remarks by the Chief Scientist, John Beddington, calling for science and scientists to be more intolerant of those that spin pseudo-science etc.  It has prompted a rather good discussion in my view.

UKCMRI Task Gets Bigger

So the UKCMRI partners were in front of the House of Commons Science and Technology Committee yesterday as were representatives of the local community.  Meanwhile the Science Minister, David Willetts, announced that the Government had agreed the business plan for the new centre as put forward by the Medical Research Council (MRC).   A good day all in all for the Centre and its supporters.

Interestingly UKCMRI is mentioned in two diagnostic articles looking back at last week’s announcement by Pfizer.  The first is by Andrew Jack in the Financial Times.  The second is by Colin Macilwein in NatureNews.   Each piece has a different accent with the latter taking a slightly more critical stance as regards the relationship between Government and pharma.  But there are also themes common to both around the need to reduce regulation and for better data sharing by companies.

I suppose Pfizer’s Sandwich plant  and UKCMRI are both of their time and I thought David Cooksey’s (Chair, UKCMRI) take on how UKCMRI will differ from what has gone before in the way it will cluster capabilities and knowledge was quite helpful to understanding why UKCMRI is so important to UK science.  

There was a lot of talk about the science ‘ecosystem’ at the time of the Spending Review and the need for the Government to avoid breaking it by not thinking through the consequences of its actions.  That’s the real issue about Pfizer and Sandwich, that together with other pharma cuts over the last few years, the UK has lost a significant amount of its pharma R&D capacity and capability with major knock-on effects for all including medical research charities. 

Against that background, initiatives such as UKCMRI take on even greater importance but the Government needs to think more strategically if we are to better manage the ecosystem going forward.  A TaskForce in Sandwich is important to managing the impact on the local community but we could do with a national Task Force as well.  One can only load so much onto UKCMRI.

And..finally from the sector…my congratulations to Alzheimer’s Research Trust who changed their name to Alzheimer’s Research UK yesterday and have a new website to boot.

Second Reading of the Health and Social Care Bill: An open letter to MPs

Dear Member of Parliament,

This afternoon the Health and Social Care Bill will recieve its Second Reading in the House of Commons.  The legislation sets out a far-reaching programme for reforming the NHS and the provision of patient care. 

The Association of Medical Research Charities (AMRC) and its 127 member charities believe that high quality research is one of the markers of a modern health service and crucial to improving outcomes for patients.  Last year medical research charities, working collaboratively with the National Institute for Health Research (NIHR), other funders, academics and patients, funded 37% of all clinical trials and other studies on the NIHR portfolio.  The NHS is crucial to the delivery of this research and is one of the reasons why the UK is an international leader in science.

At AMRC’s AGM in November 2010 the Parliamentary Under Secretary-of-State for Quality, Earl Howe, said:

‘We are committed to a future in which research continues as a core function of the NHS. This commitment is written down in the White Paper, where everyone can see it.’

We welcome the fact that the Health and Social Care Bill places a duty on the new NHS Commissioning Board to promote research and innovation and its focus on quality outcomes for patients.  But as the legislation begins its passage through parliament further clarity is needed on how research and innovation will be supported and incentivised in a radically changed NHS.

We ask that you support AMRC and its members in raising the following issues (see also our response to the NHS White Paper) with Ministers as the debate on the Bill opens:

The legislation and the changes it presages are an excellent opportunity to engender a research active culture within the NHS.  We call on the Government to implement the recommendations of the Academy of Medical Sciences’ report ‘A new pathway for the regulation and governance of health research’ aimed at embedding research as a core function of the NHS.  These include developing research activity metrics for research as part of the NHS Operating Framework, and ensuring every Trust Board has an executive director as a member who is responsible for promoting research within the organisation.

AMRC believes there are inherent risks to future research activity such as clinical trials with the advent of GP Commissioning Consortia.  Currently, many patients who wish to find out about those clinical trials in which they can participate and whose GP practice is not research active, have to rely on charities and other sources of help.  Unless GPs are supported appropriately, and incentivised through the new tarriff system, time and cost pressures will act as a further disincentive to their involvement; this despite the evidence that trial participation can lead to better outcomes for their patients. 

Finally, it is important that the Government moves swiftly to implement the aforementioned Academy’s other recommendations for reforming the regulation of health research for the benefit of patients and researchers.   These include the establishment of a single regulator, the Health Research Agency (HRA), and embedded National Research and Governance Service (NRGS) to ensure timely and streamlined approval of clinical trials and other studies.  The Health and Social Care Bill will have important implications for how the HRA might operate in practice not least in setting out the roles and functions of other regulators.

As you may be aware, the Coalition Government committed to a strong and sustained budget for health research in the Spending Review.  We welcomed that decision.  We hope that you will now support AMRC and its members in urging Ministers to ensure that the potential of this funding is  realised for patients by ensuring that the NHS is fit for research now and in the future

Yours faithfully,

Simon Denegri, Chief Executive

Getting touchy over the information revolution

Over the holidays I caught a BBC Radio 4 item about the days of the touch typist.  It was one of those gems of broadcasting which looked through a narrow lens to tell the listener much about how the world has changed.  It also brought back many memories of my time as a messenger at the old Department of Education delivering brown envelopes – many of them with a red flag meaning it was from the Minister’s office – to the typing pool.  About the same time my Dad (who was a schools inspector) got one of the first computers which sat in the corner of his office at the DofE in Arthur C Clarke fashion.  Indeed, I am not too sure who was more afraid of it – him or me.

Since then there has been an ‘information revolution’ of course,  And it just so happens that this is the title of the Department of Health consultation about information use and access in the health service to which AMRC has responded today .  We have made the following key points:

  • Research is central to the information revolution’s aspiration of delivering broad benefits to patients and society through improving access to information.
  • We welcome the government’s ambition that by 2015 “The quality and scope of information available for analysis and research will be considerably higher, more comprehensive and based on accurate recording.” and urge the government to work with us to ensure the information revolution can deliver this
  • Confidentiality and security must be central to the revolution to underpin patient support for the use of their data
  • Issues around the use of identifiable patient information in research must be addressed.
  • We urge that the recommendations of the Data Sharing Review and the ongoing work of the Research Capability Programme and Health Research Support Service be included in this strategy.
  • More focus is needed on informing patients to understand how their data will be used and supporting them to find out about research opportunities open to them.

The truth of the matteris that good information useage and good communication rely on sound leadership from the top – in this case Ministers. 

As we finalised our response this week, the irony was not lost on me that the Department should be seeking views on this issue shortly after a Christmas period in which it was roundly criticised for not pursuing a public information campaign on flu vaccination.  Why is it that, in this information age, all Governments wantonly cut back on communications, marketing and information activities?  Ultimatelyit can only short-change patients. 

I sometimes think that when politicians become Ministers they forget that they have become heads of ‘corporate’ beings.  Good communications is vital to whatever service their Department is delivering.  They neglect it at their peril  – a lesson learnt by most businesses long ago. 

For those wanting to get a grasp of some of the issues around the NHS White Paper ‘Equity and Excellence: Liberating the NHS’ of which the ‘Information Revolution’ is just one aspect, I encourage you to read yesterday’s House of Lords debate.  What would we do without the Upper House I ask myself?

It being the end of the week I should perhaps mention several other interesting bits of news from the last five days…

First, the data sharing agreement announced by the Wellcome Trust and other research funders.

Second, a union of national importance on the scale of William and Kate it may not be, but this week the Association of British Healthcare Industries (ABHI), Association of British Pharmaceutical Industries (ABPI), BioIndustry Association and British In Vitro Diagnostics Association (BIVDA) announced the formation of LifeSciences UK to facilitate joint-working between different parts of the healthcare industry and strengthen their voice with Government.  

And, third, this item about Cancer Research UK setting up a c-team of experts composed of four world-class research groups to launch a new blitz on cancer by targeting rogue stem cells that cause tumours to spread and become untreatable.

That’s it this week from the A-team.

Rawlins Review: Academy lays down law on health research regulation

Over the weekend Professor Colin Blakemore said he hoped the Academy of Medical Sciences would come up with radical proposals to end the regulatory mess that holds up UK health research such as clinical trials.

I am not sure whether he will feel today’s report by the Academy lives up to that aspiration, but I do believe it is a good and important document and I suspect so will my members. Why?

For a number of reasons.  It prefers careful surgery to the slapdash ‘slash and burn’ approach beloved of short-sighted politicians when talking about regulation or quangos.  Its prescription for the future is measured and precise – there are no sledgehammers to crack nuts here.  It takes a wide-lens view of the issues, not least the extent to which the NHS has largely been allowed to brush-aside its role in research.  And lastly, for an Academy report, there is a refreshing recognition of the importance of public and patient involvement.  A glint it may only be, but I will take it for starters.

For AMRC member charities who pulled no punches in their commentary on the current system of research regulation and governance, there will be much support for the recommendations to establish a Health Research Agency (HRA) and to house a National Research Governance Service (NRGS) within it which will focus on speeding up NHS R&D permissions.  The fact is that current delays mean it takes far longer than it should to get donor money working for research.  Also, some relief that the review panel resisted calls to collapse the myriad functions of many others regulators into the HRA.  The more one looked at this idea the more it promised a whole lotta pain with little gain.

Its many proposals for improving the culture around health research are not necessarily new – indeed a number of them have long been muted.  But to see them packaged as part of a report which is essentially about better and more efficient delivery of research is extremely important.  It moves us away from considering them as soft components of reform.  They are just as important as cutting red tape and always have been; ministers must now galvanise this culture change with their own backing.

On patient data issues the Academy nudges rather than propels us towards reform. It focuses on specific  levers and measures such as ‘safe havens’ that might get us out of the current fix, while supporting ongoing initiatives such as the Research Capability Programme (RCP) pilots and the North West Exemplar.  Its proposal to make researchers part of the clinical care team would likely have benefits beyond just improving recruitment to clinical trials; it would complement the Academy’s overall call to get the front-end of this debate right by improving NHS staff and public awareness of the importance of patient data to research.  And it almost goes without saying that I am delighted the Academy strongly endorses AMRC’s public awareness work in this field on behalf of, and with, other UKCRC partners.

The fact that the report cites a considerable number of voices from the patient workshop that AMRC and INVOLVE held in November 2010 is helpful to its overall tone and style and it includes the headlines from our independent report of this event without amendment.  It also makes a number of references to the importance of patient and public involvement to the conduct of health research.  But it doesn’t quite give the weight or billing to the need to facilitate greater involvement in the way that I and many others see as integral to improving the UK’s performance in clinical research.

And if there is one further criticism I would make, it is that the Academy keeps a respectable distance from prescribing the leadership make-up and governance systems for the new regulator HRA. It would have been good to have seen it float a few ideas and proposals that further demonstrated that it had taken on board the importance of regulation in ensuring public trust and confidence.

I see that Andrew Lansley has been quick off the mark in welcoming the report.  Watch this space as they say.

Of the coverage I have seen so far I rather liked this one most.

Regulating research – Blakemore/Deer comment pieces + AMRC background

Ahead of next week’s Academy of Medical Sciences (AMS) much anticipated report on medical research regulation I see  The Times and Sunday Times (both paywall) have published pieces this weekend by scientist Professor Colin Blakemore and journalist Brian Deer respectively, offering different perspectives on the issue of regulation.

If you are looking for further background on this issue, a reminder that you can read more about patient views on research regulation in the independent report published by AMRC/INVOLVE on 20th December 2010.  And AMRC’s two written submissions to the Academy’s review can be found on our website.

The Academy’s pages on the review are available here.

More NHS patients participating in UK clinical trials than ever before

A piece of good news with which to begin the New Year.  PharmaTimes is reporting that the number of patients participating in clinical trials jumped by 67% last year to over half a million (compared to over 300,000 in 2009).

The new CEO of the National Institute for Health Research Clinical Research Network Co-ordinating Centre (NIHR CRN CC) – which provides the machinery for how clinical trials are delivered in the UK, Jonathan Sheffield is quoted as pointing to the involvement of the wider NHS (not just teaching hospitals) and increased public awareness as key factors behing the increase. 

A rather interesting piece of news I thought given a) today’s news about the ‘polypill’ trial going ahead, b) the impending Academy of Medical Sciences report on medical research regulation and, on a more personal note, c)  that these first few months of the year shall see me busy working with patients and colleagues in NIHR CRN CC to ensure an even better plan for the implementation of patient and public involvement across the UK’s clinical research networks. 

Jonathan alludes to this work in his interview and it is an area where medical research charities have had, and will continue to play, an important role  – assisting in patient recruitment to trials, raising awareness among patient constituencies of the importance of research, as well as funding such trials themselves of course.  As NIHR figures showed last year, 37% of all clinical studies on their portfolio are  funded by charities. 

Hopefully the Academy’s forthcoming report will show the way to how we might build on this success.

An evening of industry – how the pharma business model is changing

So it’s 10pm and I’m busy here putting the final touches to the AMRC/INVOLVE report of the workshop we held in November which drew together patient views on health research regulation. 

This was at the invitation of the Academy of Medical Sciences as part of their review of regulation and governance but – and all credit to them – we agreed that AMRC/INVOLVE will produce its own independent report of the event and I hope this will be out before Christmas.

Anyway, that’s just a bit of context for you.  While writing, I listened to an excellent edition of ‘In Business’ entitled ‘Bitter Pills’ looking at changes in the pharmaceutical industry with a focus on GSK.  Its worth a listen if you are interested in how the business model for pharma is changing fast.

Nudge nudge, wink wink

‘Medics’ will be gathering in Scotland this week for a 5-day meeting at the Royal College of Physicians of Edinburgh to discuss the medical breakthroughs that have done most to shape and indeed saved lives over the past fifty years. 

Scotland on Sunday have a report today previewing the meeting.  The article includes a list of the top 20 advances as voted by over 600 ‘docs.’  Antibiotics came top and Scotland has a link to 8 of the top 20; interesting also to see things appear in the list such as randmized clinical trials.

But Office for National Statistics data published earlier in the weekend shows that Scotland still has mountains to climb in combatting the biggest killers in society – cancer, heart disease and stroke. (Note the very important health warning on the stats though given by the British Health Foundation).

The challenge is that it will require not just new medical breakthroughs such as stem cell treatments or stratified medicine but also changes in people’s behaviour as well if we are to truly win the battle against them,  And that is what will probably mark the next 50 years out from the previous 50 in many respects.

So, I have been following with interest the House of Lords Science and Technology Sub-Committee Inquiry into behaviour change that is underway. The committe have already taken evidence from members of No 10’s so-called ‘nudge unit’ and Government departments and I think witnesses from MRC and other science organisations are up before the committee on 30th November.

This committee may be going quietlyand efficently about its business outside of the glare of media attention but sometimes a ‘nudge nudge, wink wink’ can speak volumes.

When good medicine is the casualty of hype and ignorance

I have just returned from the Financial Times’ offices, where I was the guest for their regular science podcast hosted by Clive Cookson and Andrew Jack (it will appear here later today).  The theme of the discussion was ‘Selling Sickness.’  Andrew was reporting on a recent conference of the same name that took place last month in Holland.  The programme and presentations from the conference can be found here and they made interesting reading as I was prepping last night.

For those who don’t know, ‘Selling Sickness’ is a term used to describe the way in which the pharmaceutical industry and other companies are said to collude with medicine and science to create markets for new and existing products.  The claim is that they do this either by exaggerating the existence of a condition, fashioning a disease out of what one might call the ‘unbearable ordinariness of being,’ or playing on the anxieties of both the worried well and unwell.  Sometimes all three of course, as I am sure many of us have witnessed.

It is a contentious issue and the discussion this morning was interesting.  That companies should be able to hop, skip and jump through the established routes of defining disease in order to market and sell products should be a concern to us all.

From a patient and medical research charity perspective the worry is more specific.  It is that such antics lead the genuinely-ill down the wrong road with regard to treatment, while encouraging the genuinely-well to believe the worst and follow a path that means taking unnecessary risks with their health.  Only through a combination of greater openness, better regulation and also patient champions working with and within companies can we perhaps avoid the worst vestiges of this.

But it also says something about deep trends and changes in our culture and society.  One in which the expectation is set that we must all carry some vestige of ill-health or impending sickness if we are to be ‘complete,’ to be able to exercise choice in its fullest sense in a world increasingly run on fear and neurosis.

The irony of course is that, as individuals, we are not good at taking medicine which is right for us.  Also, that people are generally lacking in the support needed to alter their treatment regime if and when their condition changes.  The challenge is not so much medicines wastage but how to ensure more effective use of existing medicines.  That certainly seems to be the evidence published toay by the York Health Economics Consortium and The School of Pharmacy, UCL.  

This study shows that waste from primary care prescriptions amounts to about £300 million a year.  As the authors point out, in the context of an £8 billion drugs bill in the UK, that’s not bad. Indeed, the report is at pains to say that the NHS is quite robust at tackling waste i.e the stuff that is thrown away.  The real issue, it says, is ensuring more effective use of medicine:

‘The new research finds that up to £500 million of extra value could be generated in just five therapeutic areas (asthma, diabetes, raised blood pressure, vascular disease and the care of people with schizophrenia) if medicines were used in an optimal manner,’ it says.

Pharma Times is reporting today that Earl Howe (who is speaking at our AGM tomorrow) last week backed the idea of a new medicines service attached to pharmacies to help improve medicines adherence when he spoke at the Pharmaceutical Services Negotiating Committee annual dinner (I miss all the best gigs in town).

Moving swiftly on, the research by the York and London teams could not be more timely.  For the last six months I have been involved in a fascinating piece of work stemming from the Royal College of Physicians report last year: ‘Innovating for health: Patients, physicians, the pharmaceutical industry and the NHS.’   Following its report, the College established a ‘Medicines Forum’ which was charged with looking at how the report’s recommendations could be taken forward.  This was to be done with the help of some sub-groups focusing on specific streams of work.

I am on what is called the patient sub-group – chaired by Harry Cayton and composed of patient representatives, pharmacists, GPs, regulators and others including Professor David Taylor from the School of Pharmacy at UCL.  We have chosen to focus on two issues: medicines concordance and; public involvement in research.  We are nearing the end of a series of enrgossing evidence sessions with a wide variety of people and organisations – from Boots the Chemist to the Royal College of Pharmacists, from the Science Media Centre to some of my members such as the Motor Neurone Disease (MND) Association – and will report to the College shortly ahead of a conference it is doing in February.

I feel that we are arriving at a good diagnosis of why people don’t take their medicines (it is as much to do with the quality of interaction with a health professional as with the quality of information).  We are now turning our minds to some solutions and recommendations.  I am sure that the need for more investigation and research into this issue will be one of them, and I hope that my members will take up the challenge as I know some already have.

But it has also highlighted for me that,  in the endless discussions about translational gaps in getting science from the bench to the bedside, we have spent far too little energy in the UK exploring how to ensure that it gets from the bedside to the, well, patient’s inside?  A simple process one would have thought.  But many influences can determine whether it happens fully, partially or not at all; I have already mentioned just two.  In the drive to create and develop medicines that meet real need, we must not forget the need to pay greater attention to this final, translational gap. 

That’s a long way from selling sickness I know.  But much more in the public interest, wouldn’t you say?

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