‘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.