Will the results of the Phase III Rituximab trials leak before publishing?

Benji

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Maybe some researchers here would have experience on this
It’s common for findings to be shared at research conferences pending the peer reviewed publication
That is true.
Although It seems that everyone is even more conscious about not leaking anything now, when the publishing is not so far away.
But is there a research meeting of conference quite soon, where F & M will attend? I dont know.
 
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Fluge and Mella specifically said they won't put the data out prior to publication, I believe. Now, google of course won't show me where I saw that. But it stuck in my mind for a couple of reasons: 1. disappointment we'd have to wait; but also 2. hope they're expecting to make a great big splash with a very positive result published somewhere very noteworthy.


edit: I may be wrong, because on Reddit, a month ago, someone wrote this:

"My father talked to a researcher in Norway who's been working with Fluge and Mella. He said that he expected the Rituximab results to be revealed before the time of publication in a peer-reviewed journal. This because of how the pharmaceutical company that owns the patent to the medicine will be very eager for more profits and sales, and will be pushing for information, as the CFS patient-group is such a large one globally. He expected the first info to come in Jan/Feb 2018, however the journal article can be delayed for a while after that, depending on how it is received by the peer-reviewers. That's just a guess though, but an educated one at least."
 
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Journals prefer you embargo your results fully. It is the journal's advantage of exclusivity.

The vested interest of stockholders outweighs the journal preference, and in turn average positive results can be published in second-tier journals. F&M do not have such an obligation.

Releasing them would be rare from what I have seen.

The group is sacrificing current patients for six months to give hope to the future ones.
 

alex3619

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Journo: “Prof. Mella , you have seen the results of the study, are you encouraged by them & do you feel positive about it’s efficacy?”
Mella: “yes”

(as an example)
Yes, a short simple statement without details or data would do a lot to alleviate concern many have. This study is very important to the community.
 

Forbin

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Sidereal

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Hopefully there will be no leaks because that would jeopardise publication in high-impact journals who want exclusivity and thus have embargo on results. It is frustrating to have to wait a little longer but it's better to have the trial published in a good journal than to satisfy our curiosity early and then end up in some open access pay-to-publish journal like PLOS.
 

Forbin

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When a blinded trial is over, do patients normally agree not to discuss their personal results prior to publication? Do patients even know whether or not they received a placebo prior to publication? I'm just wondering to what extent the patients themselves remain "embargoed" or "blinded" prior to publication.
 

Benji

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The participants now know what they got. They were informed quite soon after the study finished.

I think they’re told not to share? I don’t know.
 
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perrier

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All I can add here is that when fecal transplant studies were being done to control recalcitrant cdifficile, and the results were astonishingly good, the news was released before the studies were even complete in order to give other suffering patients options for recovery.

What this story means in the current discussion regarding rtx I'm not sure....that results were uneven...?.....surely, spectacular results would prompt the researchers to have mercy on the suffering....I agree with the point made above by Kenny Banya

We are here talking about very extreme states of disability.
 

Sidereal

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All I can add here is that when fecal transplant studies were being done to control recalcitrant cdifficile, and the results were astonishingly good, the news was released before the studies were even complete in order to give other suffering patients options for recovery.
The difference, though, is that abx resistant C. diff is a fatal disease. It's a medical emergency and a public health issue.
 

Kenny Banya

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The difference, though, is that abx resistant C. diff is a fatal disease. It's a medical emergency and a public health issue.
Yeah it’s common, such as with cancer drug trials, to give the drug to those who got placebo if the response rates were exceedingly good, to stop people dying. Drugs in this scenario also get government approval fast tracked.
 

perrier

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The difference, though, is that abx resistant C. diff is a fatal disease. It's a medical emergency and a public health issue.
We had a family member suffer cdiff for 4 months, bed bound, taking antibiotics with no response until the 4 month mark. No one worried about this being a medical emergency.
 

Sidereal

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We had a family member suffer cdiff for 4 months, bed bound, taking antibiotics with no response until the 4 month mark. No one worried about this being a medical emergency.
Sure, it by no means kills everyone. But thousands of deaths, perhaps as many as 15k, are caused by C diff every year in the US. The same cannot be said for ME/CFS, as horrible as this illness is.
 

perrier

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Sure, it by no means kills everyone. But thousands of deaths, perhaps as many as 15k, are caused by C diff every year in the US. The same cannot be said for ME/CFS, as horrible as this illness is.
Yes that's true. The year our family member became ill, was described by Dr Borody in Australia as the most virulent year. Thousands died in Canada here.

But still CFS is a most horrific illness, and the suffering is extreme. Mercy please.
 

perrier

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I just spoke with a lawyer who has a little knowledge of these matters. He said that if a medication during a trial is a breakthrough medication that the obligation is to give it to the participants who were on placebo, and to release information ASAP.
Anyone with more, please add.