We are looking for feedback on the #NIHRoktoask campaign from patients, researchers, everyone…. Please help and RT.

We are the only country which runs a public awareness campaign across our national health system to encourage people to participate in clinical research – NIHR ‘OK to ask’.  We’ve been doing it for three years on the trot to coincide with International Clinical Trials Day (ICTD) in May.  Now we want your views on how this year’s campaign went and what we should do next.

It doesn’t matter if you are a local organiser for the ‘OK to ask’ campaign, a patient or carer who took part in an event, a researcher or clinician who helped out.  We want to hear from you. And if you need a little reminder of what happened here’s a ‘storify’ of the year’s events.

But even if you have never heard of the National Institute for Health Research (NIHR) (let alone ‘OK to ask’) before, we’d still like to get your views.  For what you tell us will be used to:

  • produce a report about the ‘OK to ask’ campaign in 2015 this year which will be made publicly available on NIHR’s website and through our networks.
  • think about and plan our public awareness work about research for the future.

You can complete the online survey by clicking on the link here.

And there’re plenty of time to also send on to your friends and colleagues because the survey is open until Friday 11th September 2015 to respond.

Thanks in advance for your help.

Best wishes as ever,

Simon Denegri
NIHR National Director for Patients and the Public in Research
Simon.Denegri@nihr.ac.uk

Old rules need not apply – Is Apple tearing up the rule book with #ResearchKit?

‘Purdah’ will very shortly fall over Whitehall as the General Election looms.

At the end of March the airspace over government will be closed for six weeks or so. No new flights of Ministerial fancy can take off. Those already in the air may continue on their way but must do so in radio silence.

Still, we have a few weeks to go yet. And a number could still get off the ground in that time.

The Budget is always an opportunity for pre-election give aways. We await the publication of more details of George Freeman’s innovation and medtech review. The report and recommendations of the Breaking Boundaries may well get clearance to leave its holding pattern.

All perfectly proper and natural of course, albeit frustrating.

The big news in research this week has not come from the UK Government. It has come from the United States. Apple – in its annual showcase of new offerings – launched ResearchKit. https://www.apple.com/researchkit/

This technology will allow researchers to build apps to recruit Apple consumers to research as well as to use their data and activity to answer scientific questions.

I say ‘will’ but actually five projects are already underway including ones in asthma, heart health and Parkinson’s. Last night, one of the research teams involved said over 10,000 people had signed up to their project in the days since ResearchKit was launched. It would have taken them many, many months to have achieved the same recruitment through traditional routes, they say. http://www.bloomberg.com/news/articles/2015-03-11/apple-researchkit-sees-thousands-sign-up-amid-bias-criticism . That’s quite something.

As you might expect, Apple’s foray into this arena has divided opinion. Some say revolution. Others wag their finger. Thousands of column inches have already been written about the ethics, potential bias in the research because of the narrow profile of Apple’s iPhone customer base, and why they haven’t teamed up with other companies such as Google to expand its reach.

All of these are valid questions that need answers. But, I for one, can’t help but feel genuinely excited by what Apple have launched. And perhaps the early impact tells us something about the different ‘contract’ consumers feel they have with the Apples of this world versus their Government.

Use of data, new technology platforms for its analysis, furthermore its use to engage consumers, has been the talk of the town for years. It’s been the ‘apple in the eye of the health research system.’

However, this week, it feels as though that Apple has stepped out of this eye – in the manner of 007 in those opening titles to any James Bond movie – fired the gun and completely changed our field of vision.

Y’know I think Apple will be quite happy to have ignited the ensuing debate. It will not worry too much about the criticisms. It will expect its partners to help them address these. It recognises that this is an area where old rules need not apply and some rules need to be broken. It has the relative freedom to do this while others review reviews and wring their hands. It also knows it’s consumers better than researchers perhaps know their participants?

There is perhaps one criticism or disappointment I would level at ResearchKit. It may very well be premature. But, for a company which has built its reputation consumer-led innovation, I would like to see this sort of platform also opened up to patients to share their data, inquire and innovate as PatientsLikeMe has shown is possible.

That would also be true to one of its seven founding principles – empathy. I’ve been using the following J.K.Rowling quote in some of my talks lately. It’s worth pondering by all those in the business of innovation:

Imagination is not only the uniquely human capacity to envision that which is not, and therefore the fount of all invention and innovation. In its arguably most transformative and revelatory capacity, it is the power to that enables us to empathize with humans whose experiences we have never shared.

Have a good day.

Cancer research ‘sales’ to patients remain flat

Today sees the annual Cancer Patient Experience Survey published.

For the third year running it looks at the extent to which people with cancer are being told about the opportunity to take part in research. Also, how many take up that opportunity. National data is published and then statistics are provided by NHS Trust and tumour type.

The results are not that encouraging. Since the survey started including questions about research, the dial has been stuck at less than 1 in 3 people having that possibly life-saving conversation with their doctor. If anything there is a slight trend downwards  In 2012 it was 33%, inn 2013 it was 32% and 2014, 31% (see pages 61 onwards of the report).  If you have brain or haematological cancer the figure is 37%. If you have skin or urological cancer it’s 17% and 14% respectively.

I am sure some people would say the drift downward is a statistically insignificant drop. But consider this.

For arguments sake, say cancer research is a business. And say patients with cancer are its customers. Then in business terminology we would be informing the stock market that sales are flat, the growth forecast is poor, and there may be a case for issuing a profits warning. And we all know what has happened to even our biggest companies like Tesco when this happens.

What are the causes for this lack of ‘growth’ in the numbers of people with cancer being offered the opportunity to be part of a clinical trial? Why is this happening in a clinical area which had had the longest run-up at promoting research to patients?

I don’t know for sure, is the answer. But I hope that it is an agenda item at the next board meeting of the National Cancer Research Institute (NCRI). Finding out why and putting in measures for improvement will be important.
Arguably, for instance, the cancer patient experience survey should be one of its performance measures. Personally I would like to see us aim for results nearer 50% and 80% by 2016 and 2019 respectively. Arbitrary perhaps but we need to be aiming for something.

I do have an opinion as to what’s not happening. It may be wrong. Nor is it likely to be the whole picture. But it’s based on conversations with public involvement colleagues in cancer and others around the country over recent months.

I think our consumer groups in cancer are not being listened to as much as they should be. I think ‘change’ may be drawing them away from the business at hand. I think that they are not being given the funding and support necessary to be what they can be – an important part of the ‘sales force’ that delivers on the NHS Constitution pledge that every patient has a right to information about research. Finally, I think we are failing to engage their colleagues in the NHS workforce sufficiently in this agenda. But that goes for all conditions.

If I were invited to that next NCRI Board Meeting I would be encouraging them to look at NIHR’s strategic framework for increasing participation in research ‘Promoting a research active nation.’ It doesn’t hold all the answers. However, I would be suggesting they look at how to translate its clear and considered approach – from the research ambassadors programme to the ‘OK to ask’ campaign – to cancer. And then to back it strongly.

There are some reasons to be optimistic. The members of the NCRI Consumer Liaison Group are a formidable force and well-led. Our cancer researchers and clinicians are committed. Cancer Research UK now has a public engagement strategy, budget and team in place and will be putting more weight behind this agenda in the next 12 months. Let’s hope other cancer charities follow suit.

For this results is not good enough for people with cancer and their families.

Even pharma must understand the perils of Schwanning about in a storm

On New Year’s Eve I took my family up ‘The Shard,’ London’s newest and tallest landmark.  As we looked Eastwards a squall was readying itself over the North Downs; the latest in a succession of storms to batter our shores over the past few weeks.  Low-flying clouds threatened to swallow us whole.  The wind roared around the open viewing platform.

In the run up to New Year’s Day, some of our media and politicians concocted a storm of sorts about the opening up of our borders to Romanians and Bulgarians.  For a so-called tolerant country we certainly know how to serve up vindictiveness and prejudice on a repulsive scale don’t we?

Fact is we probably have more to fear from the Chief Executives of Swiss-based pharmaceutical companies. For they seem all too ready to serve up damaging judgements on the UK’s health system.  Earlier in 2013 I had cause to write about those chocolate teapot moralists from Novartis .  They had felt it necessary to call an emergency meeting in London to admonish us about how the state of clinical research here (I hope they got my Xmas card with its personal message about the UK achieving ‘first global patient into trial’ in 23 commercial studies during 2013).

Then, over the holidays, the CEO of Roche Severin Schwan decided to fall back on tales told to him by a few mates who have lived in other countries as evidence for telling The Times (paywall) that the UK doesn’t value life.  Perhaps they were just happier because they could buy it?  I’m afraid the rest of the interview – and a broader contextual piece about pharma in The Economist in which Schwan also features – just goes to prove that Mr Schwan and his colleagues know ‘the price of everything and the value of nothing’ as my mother would put it.

Last year, the pharmaceutical industry was buffeted by the successful #AllTrials campaign calling for all clinical trial results to be published and to be made available.  The focus and intent of the campaign was strongly endorsed by the House of Commons Science and Technology Select Committee.  Industry execs probably thought they were through the worst of it with the deal hatched in Brussels just before Christmas over the new EU Clinical Trials Regulation.

How wrong they were.  Today’s report by the House of Commons Public Accounts Committee just shows it was the eye of the storm.  There will be no let-up in this drive for greater openness and transparency until practices change for the good and for good. And we are a long way from it happening just yet.

With a £12 billion profit to hand surely even Mr Schwan and his top execs can afford to see that there is an ethical and moral bottom line in play here?

A Very Happy New Year by the way.

 

 

 

Big month in Brussels for clinical trials…but let’s not be hasty

It’s going to be a ‘big-ish’ month in the EU for clinical trials.

By most accounts, EU legislators will reach a compromise agreement on the proposed new Clinical Trials Regulation in time for Christmas.  The key focus for industry bodies is around making sure the legislation embraces aggressive timelines for the approval of clinical trials.

Remind me, isn’t there a well-known saying about ‘haste’ and ‘speed?’

Anyway, I am afraid industry interests dominate the corridors and bars of Brussels and most of the self-proclaimed ‘patient-groups’ lobbying on this legislation bought into the corporatisation of clinical research long ago.  So, what we have had is lots of industry positioning coolly argued as meeting ‘patient need,’ but very little acknowledgement of patient rights.

Last week the industry-backed European Federation for Good Clinical Practice (EFGCP) sent out their report of the ‘Multi-Stakeholder Roundtable Meeting on Sharing Clinical Trial Data in the Interest of Patients and Research’ which they hosted in October.  I was struck by this quote from the report:

“One – perhaps unexpected – outcome was a focus on the participants in clinical trials. “We have to do a lot more to get back to individual patients involved in clinical trials,” said Ingrid Klingmann (EFGCP). “We owe that to patients for their willingness to contribute to the trial. At present that concept is not embedded in the proposed Regulation – but as a fundamental right it should be.”

Perhaps it was unexpected because there hasn’t been any meaningful dialogue with patients about what they want from clinical trials.  And I don’t just mean about the outcome of such research, but how people would like these studies to be conducted.

Question is….have EFGCP and others listened to the patient voice?  And, if they have, whether we can expect them to urge for the legislation to embrace the right of people to receive the results of trials they have been part of and for all studies to involve patients and the public to be involved in their design.

Must go. Haven’t quite finished my letter to Santa.