New pilot study in the loop from the researchers at Haukeland

[Bob]

I think it's fine to speculate about this, and to discuss the possibilities. Based on what other researchers have said about their soon-to-be-published studies, it would be fine to know what type of study is being published, and to have a hint about whether we should expect some positive results in general. To interfere with the publishing process, the red line seems to be releasing/discussing the specific results before they've been officially published.

 

[alex3619]

If a study has all the patients figure out who is placebo and who isn't, then it sabotages an entire arm of the study, and it will probably never be published. Studies collapse because of things like this.

This is very different from speculation.

Now if conference proceedings are leaked, including detailed analyses and results, that is a problem. Patients usually don't have access to this kind of information.

Anything more vague than that is unlikely to cause issues.

New possibilities, however vague, bring hope. We need hope. While Ritixumab is something we need to investigate, we also need to look beyond it. It wont be the last treatment no matter the results of the phase 3 trials. It might however become our first big treatment that becomes widely used.

 

[Jonathan Edwards]

I don't know if researchers are aware of quite how intensely we discuss these things on the internet and I don't know quite how much of a study's 'story' has to have been made public before it would affect its chances of publication. My concern is that if a patient has picked up from somewhere some extra information about results etc. that go beyond what F&M themselves have said publicly, they might pass that on, not realising that it might damage the chances of publication.

I don't know the limits of what it's OK to discuss - I'm asking that question, really.

It will not damage publication, Sasha. The only issue here is on permission to present at a society meeting that likes embargos so that it can claim to be first to release data. Nothing like that applies to formal publication. You can present material twenty times at meetings and still publish as long as you do not publish in two journals.

 

[Sasha]

It will not damage publication, Sasha. The only issue here is on permission to present at a society meeting that likes embargos so that it can claim to be first to release data. Nothing like that applies to formal publication. You can present material twenty times at meetings and still publish as long as you do not publish in two journals.

Thanks - but what happens if someone says, 'well, I heard that they're using Drug X and that 80.5% of patients on Drug X returned to work after 6 months but only 20.6% of controls'?

I suppose my question is really, what counts as 'data' and what counts as 'publication' in this context?

 

[Jonathan Edwards]

Thanks - but what happens if someone says, 'well, I heard that they're using Drug X and that 80.5% of patients on Drug X returned to work after 6 months but only 20.6% of controls'?

I suppose my question is really, what counts as 'data' and what counts as 'publication' in this context?

Publication in this context just means publication by some media organ (i.e. journal) that has an interest in maintaining its own claim to involvement in intellectual property or precedent and in this case all that matters is that no other similar organ should want to challenge the priority of such a claim. In other words acceptance for publication is only jeopardised by some form of public communication that might be associated with a challenge to the accepting journal's copyright. If Sasha puts on PR that 80% of patients went to work nobody is going to mind as long as they are reasonably confident that PR is not going to say 'it was our Sasha that published that'. Most journals have in their rules for contributors I requirement of no previous publication in a journal. That might be a bit fluid nowadays with online journals and open archive sites but there is still an assignment of copyright involved and they will know that Sasha cannot claim the copyright.

There are other issues about leaking information before all trial assessments had been completed - which I think occurred with PACE - and there would be issues about gossip about guessing who had got the real drug and such, but I doubt that is relevant in this case.

 

[greeneagledown]

@Jonathan

It will not damage publication, Sasha. The only issue here is on permission to present at a society meeting that likes embargos so that it can claim to be first to release data. Nothing like that applies to formal publication. You can present material twenty times at meetings and still publish as long as you do not publish in two journals.

In that case, Professor, do you have any inside scoop on this that you would be comfortable sharing? I know you talk to the Norwegians now and then.

 

[NK17]

@Jonathan


In that case, Professor, do you have any inside scoop on this that you would be comfortable sharing? I know you talk to the Norwegians now and then.

Even just a hint that indeed there's another drug that might be repurposed

 

[Sasha]

In other words acceptance for publication is only jeopardised by some form of public communication that might be associated with a challenge to the accepting journal's copyright.

Thanks - it's actually much narrower than I had thought. I'm a bit confused about why IiME hold their DVDs of their conferences back (or keep certain sections of presentations off the DVDs altogether) to comply with researchers' embargoes - unless IiME would be seen as claiming copyright in that situation.

 

[Jonathan Edwards]

Thanks - it's actually much narrower than I had thought. I'm a bit confused about why IiME hold their DVDs of their conferences back (or keep certain sections of presentations off the DVDs altogether) to comply with researchers' embargoes - unless IiME would be seen as claiming copyright in that situation.

I think a DVD produced by a charity would tread close enough to copyright to be uncomfortable but most of these embargoes are driven by other factors to do with presentations at learned societies, grant funder requirements and just not wanting other people to make use of data before you publish.

@Jonathan
In that case, Professor, do you have any inside scoop on this that you would be comfortable sharing? I know you talk to the Norwegians now and then.

I have no idea, I am afraid.

 

[Snow Leopard]

I don't know if researchers are aware of quite how intensely we discuss these things on the internet

I'm pretty sure researchers use the internet too! (and therefore know about the rumor-mill)

 

[Sasha]

I'm pretty sure researchers use the internet too! (and therefore know about the rumor-mill)

I know they use the internet but I'm not so sure their attention is on the same stuff as ours is.

 

[deleder2k]

The drug is working faster than Rituximab, what could it be? Ciclosporin, Mycophenolate Mofetil or Azathioprine? All of them work quicker than Rituximab (?), they suppress the immune system, and they were all mentioned on the exclusion list for the Enbrel study. Which horse would you put your quid on, @Jonathan Edwards ? If you're not a gambler, do you agree that we are on the right horse track at least?

 

[Jonathan Edwards]

No idea, I'm afraid!

 

[Anne]

I was told by Fluge and Mella that the Enbrel study was halted, so I don't think that's it.

Exiting!

 

[deleder2k]

No, it is not Enbrel.

http://clinicaltrials.gov/ct2/show/NCT01730495?term=Etanercept cfs&rank=1
This study has been terminated.
(After inclusion of four patients, two experienced moderate worsening of symptoms)

 

[Freddy]

Hi deleder2k,

5 more weeks we have to wait, am I right?
As a patient, I'm very impatient!

 

[greeneagledown]

@deleder2k -- This question is a long shot, but do you have any idea whether this pilot study with this unknown drug is placebo-controlled? I assume it's not, since it's a pilot study, but I figured I'd ask.

 

[deleder2k]

Hi deleder2k,

5 more weeks we have to wait, am I right?
As a patient, I'm very impatient!

I'm not sure if it they will publish or not. Looks like they're not at the moment (not sure about this, but it is the latest information i've got)

@deleder2k -- This question is a long shot, but do you have any idea whether this pilot study with this unknown drug is placebo-controlled? I assume it's not, since it's a pilot study, but I figured I'd ask.

3 patients. Not placebo-controlled. Follow-up study in a couple of months.

 

[greeneagledown]

3 patients. Not placebo-controlled. Follow-up study in a couple of months.

Thanks for the info.

 

[Freddy]

I'm not sure if it they will publish or not. Looks like they're not at the moment (not sure about this, but it is the latest information i've got)
3 patients. Not placebo-controlled. Follow-up study in a couple of months.

Thanks for your information, deleder2k, always very appreciated.
So it was a pilot study, it would be a shame, if no details will become public.

You are sure, it was a immunsuppressive drug?
And what was the result. 3 patients better, or mixed results, or bad results...

Still very curious.