Less haste and more speed is better for research and better for patients

The Government has today announced an Innovative Medicines and MedTech Review, beginning in early 2015. The Minister for Life Sciences, George Freeman MP, has set out a bold vision for cutting drastically the time it takes to develop and give patients access to new medicines and innovation. This news release lays out the basic aims of the review.

The language of urgency and desperation is a common accompaniment to the way in which medical research is pitched to the public.

Charities make ‘urgent appeals’ to our generosity.  Drug companies strain at the leash, only held back, they say, by red tape and grey bureaucrats.  Researchers implore us to come forward and ‘make it happen.’  Patients warn us of the human costs unless there is ‘immediate action.’ So it goes on.

They are right – or at least have every right, to make such calls. But we should be aware of the dangers to research and to patients of creating a society that is so pro-science, it forgets to ask important questions of science and itself for the matter.

At the moment, medical research has a burgeoning ‘fast movement.’  ‘Empower: Access to Medicines’ is one such lobby group that exemplifies how this agenda has come to the fore. Last week at the World Orphan Drug Congress I was struck by the number of patient organisations who came to the stand or spoke from the floor about the need for faster development times for new treatments, and speedier access to them.

Few people would deny that it takes a bafflingly long time and mind-boggling amount of money to produce new medicine; that there are surely ways in which this process can be shorted and cheapened. So no wonder Governments, major funders and regulators alike are doing all they can to make this happen – from adaptive licensing to the Health Research Authority’s (HRA) plans to establish a single approval process for approving research to happen in the NHS. (At the moment it seems everyone gets involved even the hospital porter!).

The more dangerous element to this movement is that which puts the pressure of demand – desperate and legitimate though it may be – in the driving seat. So much so that it tips the scale back towards a day when people were treated no better than guinea pigs, when doctors acted in haste or pure self-interest.

This is what is so worrying about the Medical Innovation Bill. In spite of what some patient advocates say, I fundamentally believe its passage would do serious damage to all that has been achieved in putting patient rights at the heart of the research agenda. Not to mention what it means for the enduring respect we have paid to ensuring research quality. In that sense it is the veritable wolf in sheep’s clothing. Goodness knows how it has got this far.

Clearly, as patients and the public, we have an important role in advocating for research to take place more quickly and for the fruits of its success to be made widely available. But we also have a significant role to play as active participants in research, working with researchers to make things work better and more efficiently. From being study participants to shaping its design and delivery. As the success of our clinical research networks bears witness to.

Patients and the public should be part of the pit crew not goading from the stands. That’s how we get faster, better research.

An invitation from the Health Research Authority (HRA): #patientsasregulatorypartners

Invitation to contribute to workshops about the Health Research Authority’s  Public Involvement Strategy

The Health Research Authority is running two workshops to give people interested in our strategy an opportunity to discuss it and how we put it into action. We would like these to include researchers and research funders as well as patients and the public and those involved in developing and managing patient and public involvement
The first workshop will be on Monday November 25th 2013 at Friends House, Euston, London and the second on Tuesday November 26th 2013 in Birmingham at De Vere Venues Colmore Gate in the city centre near Snow Hill railway station.
Both workshops will be run from 11.00 to 14.00 (including lunch) and will be limited to around 40 participants.
The workshops will be mainly about how the HRA uses its influence to support public involvement in health research more widely but also include the opportunity to hear about and discuss other aspects of feedback received to date on the strategy.
If you are interested in attending please email us at hrapublicinvolvement@nhs.net.
We will cover travel and subsistence expenses for members of the public (as defined in Appendix A of our strategy) who attend the workshops. They may also be eligible for a payment for their contribution of £75. Anyone who is in receipt of state benefits should contact us in advance to discuss arrangements to cover both expenses and payment for time.

Ridding ourselves of the 'red tape' worm

If you believe the Government – any Government in fact – we are all entangled in webbing made of regulation red tape that makes us look like one of those mummies emerging from a tomb in a 60s Hanna Barbara cartoon. 

However, I can’t help but agree on this occasion.  

I don’t know about you, but returning home in the evenings can become a rather painful process of physically and psychologically shedding the red tape of the day.  Even my dogs check the public notices at entrances to parks these days, so sensitised have they become to life in Britain circa 2011. 

But it is not the known regulations I worry about; there are regulations we know we know.  And we also know there are regulations that are unknown to us; that is to say we know there are some regulations we do not know.  But there are also unknown unknown regulations – the ones we don’t know we don’t know.  Now, they are the ones that scare me.

And in my opinion, it is often the case that someone’s interpretation of a known regulation can make it become an unknown unknown regulation.  I even came up with a new metaphor for how it is affecting our lives – the ‘red tape worm’ – after reading this week’s excellent issue of Eureka about cyberwarfare and computer viruses.  I must put that in writing to the new Health Research Agency when it is established this year.

Do you follow?  Well, don’t worry if you don’t because you have a chance to cut red tape for yourself – just like pruning the spring shrubs – at the Department for Business Innovation and Skills new ‘Challenge Red Tape Website.’  Health and social care comes up on June 23rd.

On a more serious note, I would probably put the rules that have often stood in the way of patients and members of the public receiving some form of reimbursement to be involved in research, as an example of a known regulation that has, historically, become a baffling set of unknown unknown regulations.  First, because of the way the rules have been interpreted up and down the country.  Second, because of the way that the way that the Department for Work and Pensions (whose acronym of DWP sounds perversely like a socialist party) dragged its feet to find a way through the mess.  Yes, this is an issue which has ‘form’ (pun fully intended) as they say in the police.

However, I am pleased to say that we are now seem in a better place.  And the excellent INVOLVE have this week published a rather splendid guide entitled ‘What you need to know about payment: an introductory guide for members of the public who are considering active involvement in NHS, public health or social care research’ which you can find on their website.

I’m off to shed my regulations as they say.

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.

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.