Category Archives: clinical research

Political spotlight on Health Research Authority (HRA) intensifies Reply

clinical research, clinical trial costs, clinical trials, clinical trials data, Health Research Authority (HRA), HRA • Tags: , , , , , , , , ,

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….

New websites launched for people looking to join a clinical trial; but will patients want a ‘coming together’ at some point? Reply

clinical research, clinical trial costs, clinical trials, clinical trials data, PatientLikeMe, UK Clinical Trials Gateway, UKCTG • Tags: , , , , , , , , , , , , , , ,

This week, patients got a couple more options for finding out about clinical trials they can take part in.

Patientslikeme (which was launched in the United States a few years ago) has unveiled its new new clinical trials site which you can find here.   Patientslikeme is capturing a lot of attention here in the UK and one can see why.  Although this is still very much a first generation clinical trials site for so-called ‘willing patients,’ I like how it presents options and choices. Its interoperability with other parts of the Patientslikeme site (including the option to join other patients online) is also to be commended.  It is well worth a look.

Meanwhile in the States a new site called Reg4All has been launched by the non-profit Genetic Alliance (not to be confused with the UK’s own Genetic Alliance).  This one’s a register, inviting you to join others online and share as much as your personal health information as you so wish, to ‘help spark health innovation for all.’  It’s interesting how heavily they plug patient confidentiality with the privacy controls reported as being ‘unprecedented.’  Other than not signing-up at all of course.

Don’t forget there is also the Government’s very own UK Clinical Trials Gateway (UKCTG) whose future development I am very involved in, as well as ClinicalResearch.com,  TrialReach, HealthUnlocked, YourTreatmentChoices .  Funny how almost all of these sites miss out the spaces between the words in their titles isn’t it?  I wonder what that is all about.

 

Anyway, the market of organisations competing for the attention of patients entering clinical trials gets busier by the day.  This seems a healthy thing to me on the one hand.  On the other, I feel patients will want to see a ‘coming together’ at some point.  Although not necessarily in the way that you might assume; it might take many forms in fact.

Agreement on some common principles and standards for how to operate as in the manner of a learning health system (there are some interesting precedents in the US for this with respect to data use)? Partnership, merger or co-operation?  Perhaps formal regulation (by the Health Research Authority)?  But, most of all, integration with their care and treatment in the NHS and how this is provided.  There will also be a growing demand public involvement in how they work; more than any of the above providers can currently demonstrate.  Also,demands for reassurances over the ‘patient experience,’ with the AllTrials agenda just the tip of the iceberg in how I predict people will increasingly set higher expectations with clinical trial providers, and those who recruit on their behalf, before signing the consent form.

Finally, here is a brief interview with Scotland’s Chief Scientist, Dr Andrew Morris.  He talks about the importance of research being integrated into NHS care and treatment if we are to grow cohorts of patients who are active in research and the building of systems that enables that.  He references the well-known DART initiative in Scotland involving 7000+ people with diabetes.

I’m off to watch the rugby now.

OECD wades into clinical trials debate, but statement on public involvement goes awol 2

clinical research, clinical trials, clinical trials data • Tags: , , , , , , , , ,

The Organisation for Economic Co-operation and Development (OECD) yesterday waded into the increasingly feverish debate about the regulation of clinical trials with a strongly worded recommendation calling on its members to harmonise approval processes.  The recommendation which is worded with the minimum of fuss, is backed by a more detailed explanatory memorandum.

But I am disappointed that the specific recommendation on public involvement from the OECD Global Forum on clinical trials  in October 2011 has not been carried through to inclusion in the documents issued yesterday.  As far as I can see anyway. The Forum had stated the following:

C.3 Increase patient involvement in clinical-trial processes
More direct involvement of patients in the design and monitoring of clinical trials – as well as
their contribution to improve the quality, safety and relevance of clinical research – is of
critical significance for the success and impact of clinical science as a whole.
The roles of patients in clinical trials should be strengthened by means of:
 Mandatory participation of a representative of patients’ opinion in ethics committees
(as such, they would be involved in the decision regarding future risk categories of
clinical trials).
 Consultative and participative role in the planning, design, conduct, dissemination
and implementation of results from clinical science, in part mediated through the
activities of the global networks as well as their regional and local network members
and through other relevant channels.
 Simplified informed-consent documents, containing the vital information for decision
making, using shorter and pedagogically sound explanations.
 Accessible information, for patients, families and the general public. This should
include educational websites, ad hoc documents and open dialogue sessions with
clinical staff at the hospital/clinical unit level, and transparent access to clinical
registers and information databases about planned, ongoing and completed clinical
trials by regulatory authorities.

I’ll do a bit of follow-up and report back!

A bit of a public involvement mash-up including that idea for an NHS Civil Society Assembly Reply

clinical research, clinical trials, Health and Social Care Act 2012, Health Research Authority (HRA), health research regulation, Healthwatch, medical research, NHS Commissioning Board, NHS Constitution, NHS research, NHS White Paper, NIHR, patient and public involvement, research regulation, user controlled research, user involvement • Tags: , , , , , , , , , , , , , , , , , , , , , , , ,

So here’s my unsubstantiated personal theory.

It is that one of the root causes of the problems besetting today’s NHS’ is our failure to pay proper heed to the growing crisis in accountability and responsibility that has been a feature of our increasingly complex health system over the last seventy years.  From almost the day that the NHS was born in the arms of a post-war nation, we have shown a lack of courage towards involving the public appropriately in the maturation of the service.  In this vacuum, the evolution of the health service has been driven as much by unchecked romanticism (think of the Olympics ceremony) as anything else.  Ideology has stymied the pragmatism that was needed to meet successive challenges.  These challenges only get more daunting and difficult the more we delay.  In my view, we can only resolve them by reforming its corporate governance so that patients and the public are involved in the running of the NHS from top to bottom.

With that in mind, that’s why I tweeted yesterday in support of the idea going before the NHS Commissioning Board to explore the idea of a citizen and community assembly (NHS Civil Society Assembly).  You can find out more details about the proposal being considered at the Board’s meeting on Thursday 28th February in Manchester (you can register to attend) here (see Item 4).  It’s a start.

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The Guardian has posted its round-up of the on-line chat that I and others took part in regarding patient feedback in the NHS.  The conversation ranged far and wide with little focus but it was interesting nonetheless. The ‘Francis report’ was published the day after and I seem to recall someone somewhere tweeting that patient feedback would be the source of trust in the NHS.  Seemed a faintly overblown and risky claim to make.  Ensuring that people can give their feedback and know that their concerns will be taken up is critical.  But it will take more than this to restore people’s faith in the service.

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Rare Disease Day is coming up later this week on 28th February (see Rare Disease UK website), so it seems worth pointing to several recent news items that have focused on efforts to bring about greater flexibility in how we do clinical trials.  All with the intent of getting new treatments to people faster.  First, this from the USA where the Food and Drug Administration’s (FDA) is talking about approving so-called  ’Breakthrough’ therapies after only a limited number of research studies.

Closer to home you may have picked up on the Empower: Access to Medicines campaign including e-petition to the UK Government which, as of today, has 711 signatures.  Les Halpin, who has MND and is one of the founder’s of ‘Empower’ was interviewed on the ‘Today’ programme in a curious piece which seemed to mash-up several issues: the right of people to choose to receive treatment with untried medicines (see also Lord Saatchi’s Bill in the House of Lords right now); how regulation is slowing up medicines development and; the problems with the EU Clinical Trials Directive.  The discussion is important but so is clarity of purpose, motivation not to mention the solution.

Talking of regulation, if you check out the Health Research Authority (HRA) website and the presentations from its recent ‘stakeholder forum’  you’ll see there is an update on its public involvement activities including the Sciencewise project looking at public attitudes to health research regulation.  I imagine we will see the results in late Spring and they should be fascinating.   Plaudits to the HRA for taking up the challenge to improve the evidence on what the public think in this area.

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And in other news, the NIHR School for Social Care Research has published the scoping review of ‘User Controlled Research’ by Peter Beresford and Suzy Croft.  A must read.  And finally, this looks wonderful, a new charity devoted to improving mental health research through the involvement of service users – ‘The McPin Foundation.’  Hopefully I will have cause to write at greater length about them in the near future.

‘Best left alone’ is not the motto we want for our health regulators 1

clinical research, clinical trials, Health Research Authority (HRA), health research regulation, public involvement • Tags: , , , , , , , , , , , , , , , , , , , , , ,

It being half-term you can never have enough travel games on hand.

Current favourites for me are: a) guessing who will be the new Director of the Wellcome Trust and; b) thinking of  a name for the body  created if you merged all the current Research Councils into one.

I did apply for the former post since you are asking.  I am very hopeful that my double-whammy pitch of making 75% of the Wellcome Trust Governors members of the public or patients (all of whom will be paid a very reasonable INVOLVE rate of £150 a day), and of building a ‘Crick’ in every town in the UK so that everybody has a ‘Crick in their neck of the woods,’ will get me the job.  In the meantime Ted Bianco (no relation to Matt as far as I know) will be Acting Director from March.

As for that merged body, the leading name is ‘Best Left Alone,’ on the basis that all future Science Ministers with not a clue, will find this a reassuringly named out-tray in which to put offending papers for ‘those experts to deal with.’  Not only that but, given the organisation will be based in Swindon, to most Ministers that’s as good as putting it at the end of an unmarked exit on the M4.  And, at the very worst they can quite quite truthfully report to parliament that all Government funding for the science councils has gone down a BLACK hole.

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If I don’t get to see any of these visions come true then I shall turn my attention again to saving the Royal Institution (RI)  as I did just a few weeks ago.  I see the Chair of the RI Board of Trustees, Sir Richard Sykes, wrote a blog in The Guardian on 8th February with this rather curious paragraph in it:

Those present at the meeting agreed to join a Future Direction Committee, tasked by the trustees of the RI to put forward their recommendations for this new vision. Chaired by Robert Winston, this committee is determined to come up with a vision that is shaped in consultation with the wider community, including the RI membership. In my opinion, this is our opportunity to create a national strategy for science communication, advocacy and public engagement if we want Britain to be the best place in the world to do science.

Note the rather telling reference to ‘wider community’ in terms of the RI membership and begrudgingly at that don’t you think?  Sort of counts you and me out then doesn’t it?  This is all very odd given the RI campaign message is, and I paraphrase, ‘save it for the nation.’  Er, would that be the same nation, that falls outside of the wider community?  Fingers crossed they show enough trust in the nation on whose behalf they act to ask us for some ideas on what could be done with Albermarle Street.  No, no, I promise to be constructive in a concreting-over sort of way (that’s a joke, promise).

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Deep down, you see – and I feel this ties all the above  together – is that I think many people in science would prefer a ‘best left alone’ way of working, it’s a sort of undercurrent behind lots of the things they say or do even when they are imploring people to help them out of monumental cock-ups from the past. This is only human nature I suppose.  But pity the poor underpaid communications teams in these organisations who have to manage such tensions on a daily basis.  Talking of which….

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There was a ‘best left alone’ essence to the broadside that Lords Willis, Patel and Winston fired at medical regulators in yesterday’s The Sunday Times (behind the pay-wall).   Lord Winston also did an interview on ‘The Today’ programme this morning which you may have heard.  The three highly-respected peers wrote that: medical regulation is slowing down science; there ought to be one regulator rather than the four we currently have and; we are wasting lots of money on multiple CEOs and communications people in these organisations, money which could be better spent on medical research.

What was weird about the letter – aside from the fact that it didn’t have any other backers even from organisations that the Peers are closely allied too – was that it read like a long-forgotten missive that had then been rediscovered and mistakenly posted without review.  The fact is, we are in the midst of significant regulatory reform in health research, the merger argument is not seriously on anyone’s agenda right now (even if, like me,you are sympathetic to it), and the line that burning quangos saves money just isn’t supported by the evidence.  It was all a bit of a surprise to me and others who thought we were beginning to reach a new regulatory settlement that was in everyone’s interests.

Then there was that stuff in the letter about salaries.  The easiest and cheapest shot to take at bureaucracy is always the one about overpaid staff.  It’s also the most difficult one to fend off.  But I can’t let it pass.  For while sometimes the criticism is justified and the question should always be asked about how our taxes are spent.  On the other hand, I could just as well be asking our research funders: can you prove beyond all reasonable doubt that every pound of the money you receive from taxpayers or donors is spent on medical research that meets patients needs and is not being wasted?  I’ve yet to see any funder be able do that I’m afraid.  And until they can, the wastage argument cuts both ways.  So, stones and glass houses and all that.

You know,  every story this last week – from the NHS to our food chain – points to the difficulties of regulating increasingly complex systems against a backdrop of constant change and with inherent challenges in terms of leadership, accountability and equity.

Medical research is no different.  Indeed, we have mountains to climb before we can say, hand-on-heart, that we have the sort of regulatory system for health research that patients and the public will expect in the future.  That’s where our efforts should be spent and we should leave no stone unturned in trying to achieve it, however much it might rile researchers and funders.  One day they might actually count their blessings that we didn’t leave them alone.

Charity right on Target with patient insights on clinical trials: where are the others? Reply

clinical research, clinical trial costs, clinical trials, clinical trials data, medical research charities, ovarian cancer • Tags: , , , , , , ,

This evening I have been reading a fascinating report about women with ovarian cancer and their access to clinical trials.

Last week, Target Ovarian Cancer published the results of their 2012 Pathfinder Study.  It is an excellent piece of work.  What I like about it is that it digs around issues to do with choice and access; both from a woman’s perspective and that of a clinician.  It’s not just about whether they want to take part in a trial or not. Thank goodness.

So, yes, we learn that 9 out of 10 women would go on a clinical trial if asked.  But, interestingly, only 3 out of 10 have been asked to take part in one compared to 4 out of 10 when the Pathfinder Study was last published in 2009.   Two thirds of those women who were offered the chance to take part in a trial did so, compared to just over half three years ago; a sign of increasing willingness among patients to take part in research.

We also learn that many would be happy to go to another hospital to take part in a trial and that most felt they received the right information to help them make a decision about taking part.

I am not surprised that personal motivation and altruism feature above possible treatment benefits in people’s reasons for taking part.  Nor that some women were put off by the possible extra strain on their lives.  However, I wonder if this might be a good focus for researchers to consider in terms of whether the design and methodology works in the interests of people’s participation – something that obviously public involvement can help with.

The story from the clinicians who were surveyed is that most seem to work in centres where clinical trials happen and the majority are involved in some way.  However, there is a general view that bureaucracy (45%), lack of time to recruit patients (38%) and a lack of trials (35%) is hindering progress.  Look further behind these results and there seems to be a strong, overall message around capability and capacity (the need for more research nurses, administrators) but perhaps a hint that people are not switching onto existing sources of help.  For instance, about a quarter say it is not easy to keep up-to-date with trials but only 9% are aware of Target’s ovarian cancer trial database.

Here’s what I hope having read the study:

- The study gives some really valuable insights into a range of choice and access issues so I hope that Target is now going to work with clinicians and others to think about how these can be improved.

- The Government recently launched local pilots of the ovarian cancer ‘Be Clear on Cancer’  awareness campaign.  Since the study found that women in the late stages of ovarian cancer are more likely to be offered the chance to take part in a trial, I wonder if some thought needs to be given to how to make women aware of clinical trials much sooner after diagnosis?

When you read studies such as this you can’t help but ask: where are the others?  If many charities were to do the same, we would be better able to build up an overall picture on choice and access, not to mention more condition-specific information.  And this, in turn, would help us change clinical practice so that more people had the chance to take part in research.

On the other hand you could continue to award thousands of pounds to researchers to keep hammering away at that molecule for a further three years.  Your choice.  I’m just not convinced it’s always the right choice for patients.

Public have their say on clinical trials gateway 1

clinical research, clinical trials, clinical trials data, medical research, UK Clinical Trials Gateway, UKCTG • Tags: , , , , , , , , ,

This is already doing the rounds on twitter but I thought I would share the email/letter that I have sent out to those who took part in the survey….

I am pleased to let you know that the results of the UK Clinical Trials Gateway (UKCTG) Patient and Public Survey conducted last summer have been published today by the National Institute for Health Research (NIHR). You can read the full report on the NIHR home page here:
http://www.nihr.ac.uk/Pages/default.aspx
 .

Over 600 people took part in the on-line survey and it is clear from their response that UKCTG is seen as a welcome and important initiative. The challenge is to ensure that UKCTG meets its full potential from a patient perspective in the coming months and years. The main findings from the survey are as follows:

• 83% of respondents identified themselves as a patient or carer.
• 80% had not heard of the UK Clinical Trials Gateway (UKCTG) before receiving the survey.
• Only 28% had taken part in a clinical trial.
• 38% said they knew little or nothing about clinical trials and would like a clear and
reliable source of information to learn more; 56% said it would help them or someone
they care for explore opportunities to take part in a clinical trial now or in the future.
• 64% said they would like to find out about trials recruiting in their local area.
• 66% said they found UKCTG ‘easy’ or ‘very easy’ to find their way around the site, 28% rated it as only ‘satisfactory’.
• 67% said they found the information provided on the site ‘very clear’ or ‘fairly clear’. • 72% said that UKCTG should help them make direct contact with a clinical trial without going through their doctor.
• 88% of patients said the site should provide people with relevant links to patient
groups, medical researchers and funders, which are relevant to a clinical trial study. • 88% said they would recommend the site to others.

The report of the survey includes recommendations to UKCTG on how it should be developed to better reflect the priorities of people interested in finding out about, and taking part in, clinical trials. Recommendations are made in the following areas: Vision and Strategy; Awareness and Promotion; Facilitation and Recruitment; Content and Ease-of-use; Access and Marketing and; Public Involvement/User Panel. In my introduction to these I talk about the need for UKCTG to adopt an operating philosophy which is much closer to the growing appetite and expectations of patients when it comes to research:

“Inherent in the survey findings is a challenge to the UKCTG to align itself ever more closely with the priorities and needs of patients looking for research opportunities. At the core of this is a desire to see the UKCTG evolve its current model as a simple ‘information provider’ to that of a more interactive patient partner, which helps supports their choice to participate in a trial or not.”

This opens up many exciting possibilities and I am looking forward to working with you in supporting UKCTG to develop a a bold vision and direction for the future. A key element in this process will be the new ‘User Panel’ and your thoughts on the most effective way to establish this which captures and maintains people’s enthusiasm are most welcome. In the meantime I would urge you to continue to promote the site and the downloadable ‘app’ through your networks and in your conversations with patients, members of the public and research colleagues.

My thanks again for taking part in the survey. I shall be writing again in due course to those of you who expressed an interest in joining the UKCTG User Panel.

….more on this tomorrow.

Research in the NHS: I couldn’t put it better than Cumbria Partnership NHS Trust Reply

clinical research, clinical trials, medical research, NHS, NHS research, NIHR CRN CC • Tags: , , , , ,

Recently I decided to ‘Follow’ as many of the NHS organisations (Trusts, CCGs etc) as I could find on Twitter.

The main reason was that as we ratchet up what we do around the patient access to research agenda in the New Year, I thought it would be good to begin to make connections on social media. What I hadn’t quite expected was that being able to see their twitter feeds has provided a fascinating insight into NHS activity. Better still that some would contact me with some brilliant examples of what they are doing in research.

Cumbria Partnership NHS Foundation Trust is one such example. They have a great research page. They also have an excellent YouTube video about the importance of research to the Trust with some excellent messages for patients and NHS staff.

Always happy to post similar examples. And I know Cumbria Partnership are interested to hear how other Trusts are using social media in an NHS context.

Don’t forget that NIHR CRN CC has a project up and running to support NHS Trust link-up and share good practice on partnering patients in improving access to NHS research. The web pages are being constructed as we speak. And yes, I shot this video at home. The occasional wisp of smoke outside the window is from my neighbour’s boiler flue (in case you were wondering).

Testing, testing: please put Testing Treatments interactive through its paces Reply

clinical research, clinical trial costs, clinical trials • Tags: , , , , , , , , , , , ,

With the sort of timing which makes me wonder whether I missed my vocation as a TV scheduler it only seems right that, on the day the House of Commons Science and Technology Select Committee has announced its inquiry into access to clinical trial data, I should ask you to road-test ‘TestingTreatments interactive.’

‘Testing Treatments interactive’ is the website version of the book of the same name first published in 2006.  A second edition appeared in 2011 written by Imogen Evans, Sir Iain Chalmers, Hazel Thornton and Paul Glasziou.  I would say it is essential reading for patients, the public, health professionals and others.  It explains why it is important to test treatments fairly. But also how to recognise reliable research and what you can do to improve it.  A pretty good primer for the current debate.

The point about the site is that not only can you read the book but it also contains many extras - podcasts, papers, games etc.

At the moment visitors to ‘Testing Treatments interactive‘ are being asked to help improve it by completing a survey .  They particularly looking for feedback from patients and the public.  And you might win a signed copy of the book if you do.

 

Help us make sense of the placebo effect… Reply

clinical research, clinical trials, patient and public involvement, patient information • Tags: , , , , , ,

I am involved in this follow-up study to one published a few months ago (and covered on this blog) about the poor information given to patients about the placebo in clinical trials.  In the first instance the researchers are looking for people to input into the design of a leaflet.  Details and contact email follows:

Have you ever taken part in research before?  Would you like to help improve the way research is communicated to patients?  Researchers at the University of Southampton are writing a new leaflet to explain placebo-controlled trials to patients and would like some volunteers to help.
We are looking for 10-20 people who have taken part in a clinical trial or other medical research.  We will send you a copy of our leaflet and you can either write to us with your comments, email us, or talk to us over the phone.  The leaflet is only one-page long, so we do not anticipate it will take you too long to tell us what you think about it.  For more information or to volunteer, contact Dr Felicity Bishop on F.L.Bishop@southampton.ac.uk

Patients need apply – European Medicines Agency (EMA) next steps on clinical trial data Reply

clinical research, clinical trials, clinical trials data • Tags: , , , , , , , , , , ,

The European Medicines Agency (EMA) has published the note of the conference held in London a few weeks ago, about its plans for proactive publication of clinical trial data.

It is now setting up five advisory groups and inviting self-nominations from people to join these.  You will find the following listing of the advisory groups, plus a form to fill out if you wish to put yourself forward, by going to this link.  But I thought it would be helpful to cut-and-paste the descriptions of the groups as on the website.

Advisory group Topics
Protecting patient confidentiality How can the Agency ensure through its policy that patient and other personal information will be adequately protected, i.e. that patients cannot be retroactively identified when clinical-trial data are released, and that applicable legislation, standards, and rules regarding personal data protection will be respected?
Clinical-trial-data formats How can the Agency ensure through its policy that clinical-trial data can be shared, in the interests of public health, in a clear and understandable format that enables appropriate analyses and a swift implementation without undue burden to stakeholders?
Rules of engagement Are there rules or conditions that should be in place before an external stakeholder can download clinical-trial data (e.g. formal acceptance of the need to respect personal data rules, uploading of analysis plans etc.)?
Good analysis practice Are there good-analysis-practice guidelines that the Agency could ask external requestors of data to consider or be aware of, and that the Agency can apply when confronted with additional analyses from external parties?
Legal aspects Are there any legal aspects other than personal data protection that need to be addressed when drafting the Agency’s policy? Are there exceptional circumstances under which data can be claimed to be commercially confidential?

At last! A patient-centred statement on the proposed EU Clinical Trials Regulation 1

ABPI, clinical research, clinical trials, EPHA, European Commission, European Public Health Association • Tags: , , , , , , , , , , , , , , , , ,

First, a brief history of time in the Europe Union (EU).

It goes slowly.

That’s it!

For the last two years or so the European Commission has been consulting on plans to revise the European Clinical Trials Directive.  The Directive has been in force since 2001.  Researchers hate it.  To be fair so do many patient organisations.   The main complaint is that it slows down research into new drugs particularly in swotty Britain where we tend to do everything by the book and then bind it in gold leaf.  That’s probably because of a) our schooling, b) we are brought up as subjects and, c) because of the same tendencies that make us enjoy queuing (select  from the above as you see fit).

Over the summer the Commission published a draft proposal for new legislation or ‘Regulation’  for consultation and it is being considered by the European Parliament.  Cue the usual confetti of responses from organisations and alliances of organisations stating what they do and don’t like.  My basic summation of these responses thus far is that they think it’s much better because they won’t need any more gold leaf.

Last Thursday, the European Public Health Alliance (EPHA) – an association of non-governmental organisations from across Europe – issued its own revised policy position.  It is to be applauded for being the only one I have seen this far which pushes the Commission hard to consider certain aspects of growing importance to patients in trials:  the right to clear information; openness and transparency, and public involvement in all aspects of clinical trials.  The following para taken from their website gives you a taster:

‘From this perspective it is also vital that clinical trials reflect the populations that are meant to benefit from them – for example women, older people and ethnic minorities – and that access to clinical trial data and reports is as open and transparent as possible, which implies full public disclosure in a central database to protect public health interests. Moreover, patients’ involvement in the process is essential; while this is foreseen in the present proposal, the extent to which patients will be able to influence the process still requires clarification.’

By contrast, this statement issued by UK commercial and non-commercial organisations could, and should, have taken a much stronger line on public involvement than it does.  Particularly given many of the signatories, a number of  whom I admire greatly and are highly supportive of the agenda.  But public involvement is only really mentioned in reference to the Regulation’s proposed panel for reviewing trials.  Such documents – jointly written and needing to be agreed by many – are often a difficult compromise.  But this one does leave the impression that research is the dominant force, spinning a golden thread of ‘we know best.’

The UK has often set the international standard for public involvement in health research.  So I hope this is not one of those examples of our country going to sleep on the job only to wake up and find that our European neighbours are way ahead of us.  As I say, time passes slowly in Europe but not when you are asleep.

Current Controlled Trials (CCT) appoints new advisory board Reply

clinical research, clinical trial costs, clinical trials, UK Clinical Trials Gateway • Tags: , , , , , , , , , ,

Current Controlled Trials (CCT), which aims ‘to increase the availability, and promote the exchange, of information
about ongoing randomised controlled trials worldwide,’ has appointed a new advisory board to help it in its work.  Other than yours truly, the Board includes Ben Goldacre and Paul Wicks (PatientsLikeMe) among its members, and is drawing on international expertise as well.

This is a really impressive operation with real ambitions to innovate and improve the information on trials that is available to professionals and the public.  So you might want to bookmark their blog or become a follower to stay up-to-date with new developments.

I feel rather honoured to have been asked to join and am very excited about getting down to work.

Australia launches new clinical trials website for consumers and it’s not as good as the UK’s (UKCTG) Reply

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We do beat ourselves up on a regular basis in this country.  Sometimes appropriately.  But often the punches fly a little too freely.

Australia have launched a new clinical trials website today to boost patient recruitment.  It has strengths.  But it is not as good as our own UK Clinical Trials Gateway (UKCTG).  For one main reason.  While on UKCTG you can search for the trials that are open with just one click.  Australia points you to a number of sites which you then have to choose from to begin your search.  Which makes it one, two, or possibly three (Skippy) clicks away from being useful.  Seems to also want to meet the needs of all audiences whereas UKCTG is focused on the patient.  And does anyone else think it looks uncannily like ours  in terms of format and style, or is that just me?

If you want to know what’s happening with the UKCTG Patient and Public Survey, I am getting there!  I’m just in the process of re-drafting the report of the results and thinking about the recommendations.  In the meantime, UKCTG is now getting 7000+ hits a month.  Not bad with no real marketing behind it.  I’ve said enough for one day.

Cancer patient experience survey results show variations in access to clinical trials and research 1

clinical research, clinical trials, NIHR, NIHR CRN CC, patient and public involvement, Cancer Research UK, cancer, patient experience, clinical trial costs, NHS Commissioning Board, patient recruitment into trials, NHS Constitution • Tags: , , , , , , , , , , , ,

The results of the annual cancer patient experience survey are out today.

For those of us committed to improving patient access to clinical trials and other research, this year’s report is particularly interesting.  As far as I know, this is the first year that the survey asked patients whether taking part in research had been discussed with them.  You can find the results of these particular questions on p57 of the report linked-to above.

The overall finding is that 33% of cancer patients said that taking part in research had been discussed with them but 67% of patients said it had not.  There are considerable variations according to tumour type with urological cancer coming out worst.  By Trusts the percentage of patients who were asked about research ranges from 14% to 62%.  Whatever way you cut it – by tumour type or geographical area – the majority of people who were asked were glad that the subject had been broached.

In a field which has built a significant reputation for improving patient access to research – thanks to the National Cancer Research Institute (NCRI) and the National Cancer Research Network (NCRN) - these figures show the work still to be done to bring research to the fore of the conversation that cancer patients have with their doctor. I would suspect that other conditions have a steeper hill to climb in comparison.

There is no magic bullet to improving access.  The survey highlights the future importance of things like the NHS Choice Framework and the strengthening of patient rights through the NHS constitution in empowering patients to ask the question. But a lot will also rest on ensuring NHS Trusts prioritise the access agend; that they make it their job to raise awareness of their research activity and the importance of patient participation in it.

This week, through NIHR CRN CC, we kicked off a piece of work – Involvement4Access - to bring together patients and support them as leaders within Trusts environment to improve patient access to research.  On Wednesday I had the opportunity to attend a Royal College of Paediatrics and Child Health (RCPCH) workshop about research where parents and young people reported very real differences in the willingness of hospitals to advertise research openly on wards, receptions areas etc.  The reasons put forward by hospitals for not being more open about research are often misconceived if not plain bunkum.

But improving access will also require patient groups and charities to do more to support the patient voice in lobbying Trusts, health professionals and others to change their approach.  There is much in this report and in the recent NIHR league tables of research activity to aid this work.  Yet patients need the right tools and information that they and their families can use confidently in order to broker the conversation with their GP or consultant. They also need to hear more from their representative bodies about how they should consider taking part in research as part of their overall treatment.

At the same time, the survey findings about people who were not asked about research on whether they would like to have been, highlights the fact that to participate or not is a  ’personal choice’ which must be respected.  53% of people said they would like to have been, 47% said they would not have liked a discussion.  Insight into the patient experience from a research perspective – at what point in their care and treatment should the conversation take place, with whom and how – will increasingly be important.  That’s why today’s survey must be repeated but also used as a prompt for further inquiry.  It should also be repeated in other disease and conditions areas as well.

At the end of the day, providing better patient access to research is about improving patient choice, leadership, insight and voice.

PM’s Global Health Policy Summit Speech signals the personal as well as phenomenal Reply

clinical research, clinical trials, medical records, medical research, NHS Constitution, patient data, Phenome Centre • Tags: , , , , , , , , , , , ,

You can find the full text of the Prime Minister’s speech at the Global Health Policy Summit in London today here.

David Cameron’s remarks have caught the headlines because of his announcement about the new Phenome Centre.

But, as important, are a number of other areas of his speech. These deal with the importance of the NHS to making research happen, the Government’s commitment to enabling the use of patient data for research including the forthcoming consultation on the NHS Constitution, and his ‘Dementia Challenge.’  If ever we had an insight into his personal priorities for his administration across health research then this speech is a pretty strong synopsis.

In other news today, the Department for Business, Innovation and Skills, announced that Donald Brydon, current Chair of the Royal Mail Group, will be the new Chair of the Medical Research Council (MRC) succeeding Sir John Chisholm in nine months time.

Clinical trials and children: impact on outcomes Reply

clinical research, clinical trial costs, clinical trials, Medicines for Children Research Network (MCRN), RCPCH, Turnign the Tide • Tags: , , , , , , , , , , ,

Interesting paper from the Annals of Oncology and covered in PharmaTimes on how access to clinical trials has led to better outcomes for children with cancer.  The data relates to clinical trial activity promoted by the Children’s Cancer and Leukaemia Group.  A direct quote from the article says:

“Between 1966 and 1970 just 28% of young patients diagnosed with cancer survived for five years, but jumping forward to those diagnosed during 1996-2000, and this figure has rocketed to 77%. Looking at data from more than 25,000 children in the first analysis of population-based survival in relation to open clinical trials, the authors found that the annual reduction in risk of death ranged from 2.7% for rhabdomyosarcoma to 12.0% for gonadal germ cell tumours.”

This also gives me an excuse to mention the Royal College of Paediatrics and Child Health (RCPCH) ‘Turning the Tide’ initiative which is aimed at strengthening child health research activity.  It is launching a report on 20th November 2012 and I’m off to learn more about where this important work has got too, later next month.

Clinical trials activity report for England highlights progress but much work still to be done Reply

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The National Institute for Health Research (NIHR) CRN CC has today published its clinical research activity report for the final quarter of 2011/12.  Some of the data and a good summary of what they mean is also available on The Guardian website.

Last year was the first that this sort of information was made widely available.  So importantly, from a public perspective, people can now look at how their NHS Trust has improved upon what it did the previous year.

The overall picture is positive.  In addition, there are some very good stories within the report about the progress being made in specific parts of the system.  I am particularly pleased to see the increase in research activity across primary care – a significant foothold that we must make sure is built upon as the NHS changes take effect.

Patient recruitment to research was above the NIHR CRN CC target, if a little lower than last year.  It simply emphasises the fact that we have much to do to ensure patients are given the opportunity to take part in an appropriate trial.  More importantly, that they know they have the right to ask.  I shall say more about this next week.  The fact that the NIHR CRN CC report slices up the data by NHR Trust and type of Trust also means we can be quite strategic in our thinking about where this push is needed most.

Yesterday I chaired the second meeting of a working group – hosted by NIHR CRN CC – that will be bringing together a cluster of public involvement colleagues in NHS Trusts across the country to develop tools and information for Trusts to improve access to research for trials.  You heard it here first.

We are on the right path.

There is no point to the javelin Reply

clinical research, clinical trial costs, clinical trials, European Commission, European Patients Forum, Health Research Authority (HRA), medical research, patient and public involvement, patient recruitment into trials • Tags: , , , , , , , , , , , , ,

It has come to this.  The world’s top tennis players rush their shots to beat an 11pm curfew.  Bruce and Sir Paul are turned-off mid-performance.  And they don’t use real javelins in schools.

Looking across the the athletics field at my sons’ school sports day, I spied a clutch of children competing in the javelin.  Except this is not a javelin as I remember it.  It’s more like one of those foam beach toys.  But nowehere near as good.  In fact it’s probably more like throwing a giant, over-ripe banana.  I admire the optimism of a small boy as he lets fly.  I imagine his disappointment as it is carried sideways by the wind and belly-flops to the ground.  There is no point to the javelin I mused.

UK scientists who have long complained about the blunt and risk-averse nature of the current EU Clinical Trials Directive, will no doubt be pleased by the Commission’s announcement today to bring in a sharper legislative instrument.  The new ‘Regulation’ will mean lighter touch regulation for ‘low-risk’ clinical trials and a streamlining of the regulatory process across the EU.  This, married with the EU’s recent enthusiasm for making trial data publicly available, also looks like good news from a patient perspective. Nature coverage here.

Whether it stacks-up against the five ‘wishes’ that the European Patients Forum (EPF) expressed during the consultation about the existing Directive remains to be seen.  The Forum hoped that any revision of EU law would result in:

1. Ensuring meaningful patients’ involvement across all aspects of clinical trials;

2. Giving patients access to quality information regarding clinical trials;

3. Meaningful informed consent;

4. Transparency concerning the results of clinical trials;

5. Access to treatments after the end of clinical trials.

Faster, quicker, leaner trials, yes.  Rules that reflect patient choice, voice and experience, I fear not.

The Commission’s own web pages have a stack of information available about the new Regulation including a ‘Citizen Summary.’ That all other documents constantly refer to research ‘subjects’ betrays the fact that the full extent of the patient agenda is not quite part of their core philosophy.  Indeed. the summary is just that, it doesn’t really convince in explaining how citizen rights and interests have been reflected in the proposals.

When is science, or more particularly medical research, going to wake-up to the fact that the effectiveness of modern regulation and modern regulators hinges on a partnership between those being regulated and their consumers?  Perhaps closer to home we might have greater cause for optimism.  The new Health Research Authority (HRA) has just had its second public involvement workshop and is working through the options of what might be tangible outcomes of this work as part of its business plan.

Back in Brussels, I hate to say it, but it still feels like we are being given foam arrows.  And with none of the fun of the beach.

Enjoy your summer holidays.