medicines

Patients and carers will tell you that all that is good or bad about health research can usually be traced to its source. That place where the idea is first formed by scientists. Eureka moment it might be, they will say, but having patients and carers involved from the beginning can save embarrassment for all concerned by ensuring the scientist does not go running into the street without their clothes on.

The story of involvement in research is not dissimilar in many sense to the account of an explorer – a tale of pioneers battling their way upstream through the rapids and rocks to find the source of the river and affect the flow.  But the journey can be markedly different depending on who owns the land where the source lies.

Let’s take industry – pharmaceutical companies and others – for instance. Their upstream research – the source of their drug development work – has been conducted behind closed doors for many years. In recent years those doors have been pushed ajar and now the opening seems to get every wider with each passing day.

Reports like today’s published by the BioIndustry Association and Medicines Discovery Catapult called ‘State of the Discovery Nation’ – which call for a radical change in the pharma model of doing things by ‘humanising’ research and put the needs and priorities of patients first (among other things) – are significant for coming from within the room rather than those outside knocking on the door to get in.

In the same vein you may be interested in this report of a discussion hosted by the Academy of Medical Sciences Forum (which brings together industry with academics, patients, charities and others) on the subject of outcomes in clinical trials. It notes:

‘Using meaningful endpoints which are relevant to regulators, payers, clinicians
and patients requires measurement of factors beyond overall survival. Overall
survival is not the only meaningful outcome and other reliable endpoints are required to
assess the impact of treatment from clinical and patient perspectives. Examples include
impact on pain relief, symptom control and other aspects relating to quality of life.
Treatments may deliver patient benefits in addition to, or instead of, increasing overall
survival. From a patient’s perspective, benefits need to be weighed against the risks and
drawbacks of treatments including impact on quality of life and daily living; quality of life may be at least as important, and potentially more so, than longevity. Impact on quality of life may be harder to capture than ‘objective’ measures of treatment responses, and there is a need for new standardised and validated tools to capture patient-reported outcomes.

And this is quite an interesting article from Pharma Times about the different ways companies such as Merck and Sanofi are involving patients and carers in their upstream work in the drive to patient-centricity (an absolutely horrendous term which feels like one step away from eccentricity or a stop on the Northern Line but I shall forgive them for it on this occasion).  As is this press release that I found on one of the business wire services which suggest patients are affecting the bottom-line for companies in different ways than ever imagined.

So, patients continue to make their way upstream against all the odds. But at least the task does not seem as hopeless as before. At least we now seem to have a paddle in our hands.

 

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.

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.

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.

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