HRA

There is much post-Brexit talk of using our new-found political independence to liberalise clinical trials in the U.K.

We can cut ourselves free of all that terrible EU red-tape that has weighed us down. Or so the argument goes. We can be quicker and more efficient than other countries. We will be more attractive to research funders and the global pharmaceutical industry in particular.

I am not so sure it will be that easy to extract ourselves completely and utterly judging by the furrowed brows across Westminster and Whitehall.

Nor am I sure we can lay the blame for our trials and tribulations in clinical research totally at the door of the EU. That’s if you accept the picture of doom and gloom that has been painted. I don’t.

We have recovered our international position well in clinical research in the last 10 years. Just look at the number of trials that are first to recruit in the U.K. This is down to the NIHR and its willingness to take on a range of vested interests at home – interests that were far more of a barrier than any EU law.

What I do know is that if things go belly up in the future we won’t have the EU to use as a punch bag. We will only have ourselves to blame.

The yet to be published and ironically named Accelerated Access Review is just such an example of how we are quite capable of slowing things down on our own in the UK. Right down until all the voices are distorted. We really don’t need any help from others.

Not everyone will greet the idea of liberalising clinical research with unbridled enthusiasm. The consumer experience of deregulating markets and cutting red tapes is not always wholly positive. Choice can come with a price. I say this as a frequent passenger on a semi-rural bus service. Need i say more.

Frankly, I wonder whether liberalisation is really the best we can for a post-Brexit moonshot. Surely liberalisation is the means to an end not the end in itself?

I would much prefer us to use liberalisation as a platform for the UK to change the face of clinical trials globally. To be the one that everyone watches.

To become the most innovative nation when it comes to clinical trial design; to be the nation that understands and reflects the patient experience of research better than ever; to be the nation that involves patients and carers in designing all its trials because this way leads to greater effectiveness and efficiency. Total public involvement in the way that Barcelona FC play ‘total football.’

However we got here, we now have an opportunity to do something amazing with patients and the public.

When I was growing up I used to help my Dad do DIY around the house.  Our perennial companion was a thick, hard-bound manual with step-by-step guides on how to do anything and everything.  No job was too big or too small for it.  From replacing a chimney stack to changing a plug.

Dad passed the manual on to me.  But years of use took their toll on the trusty tome,  the spine gave way and pages were lost.  Now we have Google, YouTube and all sorts. But there is still something I miss about that manual.  The sense that when you opened it, years of experience oozed through its clear instructions and helpful pictures.

We don’t have a manual for public involvement. Perhaps we should (Discuss?). But we do have a manual for doing research.  It’s called the UK Policy Framework for Health and Social Care Research and the Health Research Authority (HRA) – together with the Governments of Scotland, Wales and Northern Ireland – are consulting on a new version which you can find here.

To quote the official record, the Framework sets out ‘principles of good practice in the management and conduct of health and social care research in the UK…..It will replace the four separate Research Governance Frameworks previously issued by each UK Health Department.’  This isn’t some bit of guidance that is left on the shelf to gather dust.  It’s the foundation stone for ensuring that research is promulgated in the public interest.

HRA’s grown-up attitude to public involvement is reflected in the fact that references to  public involvement – and the need to protect and promote the public interest – are peppered throughout the document.  Attention to getting the detail right will be important.  In the  ‘literal’ world of research, requirements need to be spelled out precisely if they are to be acted upon. As patients we know that things will often not happen unless they are set out in this way – the devil is in the manual!

For instance, it will be important that the Framework is more assertive about the responsibility of researchers to acknowledge the contribution of research participants; to make the results of their work readily available to these partners.  Also, what this looks like in practice: how does a researcher go about achieving this goal?

Should there also be a section setting out the responsibilities of patients and the public in ensuring good research practice?  The document sets out the principles that apply to organisations and their staff doing the work. But not the citizens involved in making it happen. Should we – you and me – be allowed to go scot-free? What are our responsibilities and duties? 

Finally, I wonder whether we could do with a bit more oomph in the document.  A preamble that will be passed down through the ages.  You might recognise the origins of the following that I wrote this afternoon?

“We the research community of the UK – including patients and the public , in order to do better research to improve health and wellbeing, ensure that it is done safely, in the public interest, and in such a way as to promote and advance the greater contribution of the public to this endeavour, do ordain and establish this Framework for the UK research system.’

Well, you can have your say by taking part in the HRA’s online survey here. Or by attending one of the workshops including two being held for patients and service users in Birmingham (Feb 24th) or London (9th March).  More details here.

Have a good evening.

 

 

Now, how does the famous saying go? Some are born regulators, some become regulators, and some have regulation thrust upon them.

Yesterday our medical research regulator – the Health Research Authority (HRA) – set out its strategy for public involvement: http://www.hra.nhs.uk/patients-and-the-public-2/how-the-hra-works-with-patients-and-the-public/our-strategy-for-public-involvement/

Regulators are the modern tool by which Governments operationalise law. Years ago it used to be knights if you were lucky or mercenaries if you were very unlucky. I prefer regulators myself.

When regulators fail the consequences can be disastrous at best and end in human tragedy at worst. If you ever meet someone who argues for an unfettered market point them in the direction of India where clinical trials have been turned into slave labour.

In the UK we now have regulators of markets (such as Ofwat), of people (the General Medical Council), and of systems (the HRA). All purportedly in the public interest. But only recently have regulators actively involved and engaged the public (and even then I am being a little kind to them).

As a document that sets out its core philosophy and future approach to public involvement, HRA’s strategy is excellent. I know from my own involvement with it that it has the political will behind it to make it work. I hope you will read it and respond, perhaps even attend it’s forthcoming workshops.

My own vision is for a system of regulation in which regulators see patients and the public as regulatory partners. Applying proportionality and common sense solutions to regulation that both promotes and protects the public interest.

What roles could patients and the public play? Well, my experience is that they can help identify and eradicate unnecessary rules. They can sniff out the myths about regulation a mile off. They can help counter the assumptions that people have held unchecked – and based regulation on – for too long. For. Instance about how patients and carers view risk. They can improve the way we communicate information. They can bring others on board.

My point is that this is the new way to do regulation and run a regulator – with the public.

And I think the HRA and the people in it are born regulators.

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……

I am sure the new Health Research Authority (HRA) can take care of itself.  But the expectations being heaped on it by others show no signs of abating. I wouldn’t be surprised if tomorrow someone calls on it to cure cancer. If it had been created by a Blair Government it would surely have been dubbed ‘The People’s Health Research Authority.’ Come to think of it…..

Why do I say this?  Well, the committee of MPs and Peers looking at the draft Care and Support Bill establishing the HRA has just published its report; the Association of Medical Research Charities (AMRC) has provided an excellent overview of their conclusions here .

The key message from the committee is that the HRA should be ‘promoting’ research.  I am sure this is right. But the very real problem for the HRA is how do you define this in practice?  For the answer is potentially as long as a piece of string.  There is certainly a real danger for mission drift if it’s not careful. There is also some irony in the fact that it was onlya few short weeks ago that three eminent Peers wrote to The Times criticising the HRA and other regulators for the amount of money spent on media and communications. Damned if you do, damned if you don’t (see my blog on this from just a few weeks ago).

Did anyone else also raise an eyebrow at the conclusion parliamentarians drew that there is ‘no single body promoting health and social care research?’ Er, the National Institute for Health Research (NIHR) perhaps? For one.  It feels that the Committee has assumed the body language of funders and researchers when it comes to this thing called ‘promotion:’  quite simply they are good at promoting their own science but when it comes to promoting science in general it is rapidly becomes someone else’s responsibility. And often the responsibility of organisations that are already running on vapour in terms of resources.

Yet it is evident from the conversations I have had with colleagues thus far that generally they have been encouraged by the quietly efficient and logical way that the HRA is going about its business.  It’s approach to public involvement seems sensible given the lack of precedence for where it wants to head.  Its stakeholder event a few weeks ago was, by all accounts, excellent.  It is steaming ahead with its pilot of speeding up approvals.  These are all good things and it is important that we support their endeavour in the coming weeks and months if it is to become the fair but robust regulator we all wish to see.

Across the Committee corridor the House of Commons Science and Technology Select Committee has just  published all the written submissions it has received as part of its inquiry into clinical trials.  Some of these submissions are filtering into the press.  And this evening I noticed this piece from Outsourcing Pharma.Com about the evidence of the Clinical Contract Research Association (CCRA).  It again puts the onus on the HRA pulling things together. (By the way, I was just as interested in CCRA’s call  to simplify consent and other complex processes which stand in the way of patients taking part  in trials).

As it takes oral evidence, Committee  members will focus in even greater forensic detail on the role of the HRA in promoting transparency in the registering and reporting of clinical trials.  The Care and Support Bill Committee took a strong line on this and says HRA must lead the way.  I would agree 100% with them.  But HRA can only do this if it has strong political backing from the beginning and when it is having to face down the recalcitrant funder or researcher who won’t play ball.  All on the basis that it is just ‘red tape’ preventing them from doing their life-saving work.  For it is at those moments that the wind is often taken out of the regulator’s sails by a lack of courage of the part of our politicians.

So how the Committee chooses to deal with this particular issue is going to have an important bearing on the future workload of the HRA and how it is monitored in parliament.  In the meantime, the Care and Support Bill will establish its formal role.

Yep. There’s no doubt about it. All eyes are on the HRA and this is just the beginning….