UK research funding - UK's second largest public funding body (NIHR) is consulting the public

[Bob]

I'm not sure if this has been posted before, but i think it's worth posting again anyway, in case anyone has missed it.

The National Institute for Health Research (NIHR) is the the UK's second biggest public funding body and it is consulting the public for suggestions regarding tests and treatments that need to be researched.

ME Action highlighted it, here:
http://www.meaction.net/2015/08/10/help-shape-research-in-the-nhs/

THE UK’S NHS WANTS TO HEAR FROM YOU! HELP SHAPE MYALGIC ENCEPHALOMYELITIS RESEARCH
The UK’s National Institute for Health Research (NIHR) is asking for suggestions from patients, carers and members of the public for tests and treatments that need to be researched.

M.E. patients in the UK are all too aware of the ways the NHS falls short in its tests, treatment and care for people with our illness, and it often feels as if no one cares or listens to what we need. We’re being asked for our suggestions for research to be funded by NIHR for the NHS. Let’s step up and make our ideas for research into new tests and treatments heard.

This is the NIHR submission form. They only want short submissions, so it won't take long:
http://www.nets.nihr.ac.uk/identifying-research/make-a-suggestion

I think it could be worth making a submission. I've submitted, today.

I said that we need biomarkers and treatments for ME/CFS because there aren't any, and that ME/CFS patients are currently left to fend for themselves, and manage their own illness. I said that we are offered therapies for only some of our symptoms (e.g. pain) but that most of our disabling symptoms (e.g. exhaustion, flu like symptoms, joint inflammation and cognitive impairment etc) are left untreated.

 

[Bob]

BTW, i can't see any reason why non-UK citizens can't submit if you wish to.

 

[Bob]

Someone made this very good point to me: "I think we all ought to be asking for a multi-centre rituximab trial as well designed as the one in Norway."

 

[snowathlete]

I'll try and do this. We really need to be pushing in the UK more than we are, in my view. There are lots of issues but one is that it just isn't on a lot of people's radars.

 

[A.B.]

Someone made this very good point to me: "I think we all ought to be asking for a multi-centre rituximab trial as well designed as the one in Norway."

@Jonathan Edwards what do you think? Does this have a chance of being accepted? Is there other research that is also important and has a better chance of being accepted? For example we could also ask for funding for the B cell characterization research.

 

[Jonathan Edwards]

@Jonathan Edwards what do you think? Does this have a chance of being accepted? Is there other research that is also important and has a better chance of being accepted? For example we could also ask for funding for the B cell characterization research.

Nothing is going to be 'accepted' on the basis of lobbying through this mechanism but whatever gets suggested will at least get registered as an idea. I suspect that general points about the sort of research needed will be more useful than suggestions for specific projects. I am personally not that enthusiastic about another multicentre trial for rituximab because multicentre trials dilute the science and the quality of results. Good science is done by the people who really understand what they are asking. The big Norwegian study is necessary but even the Norwegians see its downside. The main reason for going multicentre is to show that consistent results can come from different sources. That is not an issue for a UK trial, which would be a different source anyway. My own view is that something like a dose ranging study would be the right thing to do at this point but I think that is too specific an issue for this consultation exercise.

 

[Sasha]

I am personally not that enthusiastic about another multicentre trial for rituximab because multicentre trials dilute the science and the quality of results. Good science is done by the people who really understand what they are asking. The big Norwegian study is necessary but even the Norwegians see its downside. The main reason for going multicentre is to show that consistent results can come from different sources. That is not an issue for a UK trial, which would be a different source anyway. My own view is that something like a dose ranging study would be the right thing to do at this point but I think that is too specific an issue for this consultation exercise.

I don't want to pull this thread off-track but I thought we needed more multi-site rtx studies to get it approved for ME, and that the Norwegian trials wouldn't be enough?

 

[A.B.]

Thanks for your input Jonathan Edwards. I asked for research in the area of B cell depletion for ME/CFS, with outcome measures related to real world functioning. A bit too vague for my taste but at least it brings this to their attention.

 

[Jonathan Edwards]

I don't want to pull this thread off-track but I thought we needed more multi-site rtx studies to get it approved for ME, and that the Norwegian trials wouldn't be enough?

I am not aware that it helps being multicentre for approval. It may be important to have trials in more than one country.

 

[Sasha]

I am not aware that it helps being multicentre for approval. It may be important to have trials in more than one country.

So we ought to be pushing for a multi-site European trial with UK as one of the sites? Presumably no single UK site could get enough patients to do a big enough trial to satisfy the UK authorities in terms of drug approval? Or do I just not understand this?

 

[Jonathan Edwards]

So we ought to be pushing for a multi-site European trial with UK as one of the sites? Presumably no single UK site could get enough patients to do a big enough trial to satisfy the UK authorities in terms of drug approval? Or do I just not understand this?

What matters is what is practical for the clinicians involved. I think it is likely to be counterproductive to ask for a particular research structure. That is to be decided by people in a position to carry it out.

 

[Battery Muncher]

This sounds interesting. I'll try to submit something over the next week or two.

I want us to push for further research regarding Rituximab, so that we can build on the brilliant work done by Fluge and Mella. I'm not sure how to go about this, though. I'm particularly stuck on the question "What outcome should we measure?"

If others could post up their submissions for the rest of us to see/ learn from, that would be welcome!

 

[A.B.]

If others could post up their submissions for the rest of us to see/ learn from, that would be welcome!

I think it's good if everyone comes up with their own words and perspective. It's more authentic that way.

Nobody will write the perfect comment, but taken together, hopefully all important viewpoints will be presented. The NIHR can then decide what works for them. Hopefully the topic of B cell depletion will be mentioned often enough to attract attention.

 

[Bob]

We can struggle with advocacy projects, esp when we're at a low ebb, so this is an edited version of what i submitted, in case it helps anyone. Obviously it's best if you don't copy what i've written but just use it as a springboard for your own comments.

It's probably not worth spending much time on this, because i doubt if each submission will get close scrutiny. They will probably compile a list of topics that have been submitted. And they might be looking for generalised submissions, rather than submissions relating to specific diseases. But no harm in trying!




What needs researching (what treatment, test or other intervention)?

There is an unmet need to investigate potential treatments and biomarkers for ME/CFS.

ME/CFS currently has absolutely no treatments available, either for the illness itself, for the associated disability, or for most of the associated symptoms.

As a patient myself, all of my symptoms are currently untreated, because of the lack of available medical treatment, for ME/CFS. Untreated symptoms include the following: generalised pain, incapacitating joint pain and inflammation, flu-like symptoms, cognitive impairment (inc short-term memory loss), neurological symptoms, and general distress associated with living with severe and disabling chronic symptoms.


What outcome should we measure?

Overall levels of physical activity should be objectively measured (i.e. using actometers) to assess changes in overall physical capacity.

Snap-shot assessments of physical capacity, can be unhelpful and misleading in ME/CFS because a patient can manage his/her health such that symptoms are improved by reducing activity levels, or a patient can increase involvement in specific isolated activities but overall activity is reduced.

Subjective assessments of isolated/individual symptoms, such as 'fatigue', can also be unhelpful and misleading. For example, if an ME/CFS patient reduces or manages activity levels, then they may be able improve their subjective symptoms despite there being a deterioration in the illness itself.

ME/CFS patients suffer from a range of distressing and disabling symptoms (e.g. pain, joint inflammation, cognitive impairment, flu-like symptoms, exhaustion, & susceptibility to post-exertional exacerbation), and no single symptom gives a full picture of the illness.


Why would this research be important for the public, patients or the NHS?

ME/CFS is a fairly common illness, and there are a large number of patients who are left without any appropriate interventions or treatments. ME/CFS patients have to manage their illness themselves, as there are no treatments available. It is also difficult to diagnose ME/CFS and there are a large number of undiagnosed and misdiagnosed patients.

ME/CFS is a huge burden on the economy, and if even only a proportion of ME/CFS patients could return to productive employment, this would make a huge difference to the patients themselves, to the public purse (e.g. NHS spending), and to the economy in general.

 

[Scarecrow]

Some useful info, including how to complete the form, here:

http://www.nets.nihr.ac.uk/identifying-research/help-us-shape-research

 

[Sasha]

Is there a deadline?

 

[Bob]

Is there a deadline?

I don't know. I haven't seen one but I didn't read all their notes.

 

[Snowdrop]

What kind of research and what researchers are there presently in the UK from which to suggest more specific biomedical studies that would further ME research. I'm planning to ask my daughter to submit a request she's (normally) in the UK.

She's visiting us at home so if anybody knows, does that matter in terms of her submitting ie does her computer (it's address) have to be in the UK or can she submit now while she's here because she lives/works/goes to school in the UK?

Sorry if that's a truly dumb question.

 

[Bob]

What kind of research and what researchers are there presently in the UK from which to suggest more specific biomedical studies that would further ME research.

It probably doesn't help to suggest specific researchers because funding bodies don't tend to approach specific researchers - it's the other way around - researchers are expected to approach the funding bodies with their applications. The funding bodies sometimes put out special notices saying that they wish to receive applications for specific types of research or diseases.

She's visiting us at home so if anybody knows, does that matter in terms of her submitting ie does her computer (it's address) have to be in the UK or can she submit now while she's here because she lives/works/goes to school in the UK?

I haven't seen them stipulate that submissions must be from UK residents or UK premises only. So I don't think it matters where it is submitted from. (Does that answer your question? I'm not sure if that's the exact question you asked?)

 

[Snowdrop]

Thanks @Bob.
So does this mean that anyone can submit?
I think I wasn't clear about what I was asking with regards to specific research. My bad wording especially using specific.
What I meant by that was: as an example; if I suggested microbiome research would be useful to ME are there are researchers in the UK who would be willing to make submissions? Or is this level of suggestion still too specific?
I get flummoxed easily with this stuff. Whenever I read something about this stuff I often understand only to forget what I read pretty quickly and have trouble articulating my thoughts.