Campaign to publish all medical research trial results.

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  • This topic has 12 replies, 8 voices, and was last updated 5 years ago by  b r.
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  • Campaign to publish all medical research trial results.
  • I’m never sure how effective these on line petition things are, but this one’s got a lot of big name organisations behind it and seems a good idea.
    I know there’s been a few virtual whip rounds on this forum. It’s a shame to think the money might be wasted on something that’s already been proven not to work because the previous results were not known about.

    It also affects some very expensive drugs. Governments around the world have spent billions on a drug called Tamiflu: the UK alone spent £500 million on this one drug in 2009, which is 5% of the total £10bn NHS drugs budget. But Roche, the drug’s manufacturer, published fewer than half of the clinical trials conducted on it, and continues to withhold important information about these trials from doctors and researchers. So we don’t know if Tamiflu is any better than paracetamol.

    All Trials Registered. All Results Reported

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    GSK has already agreed to do so after a sustained campaigned by Ben Goldacre and the Guardian.

    http://www.guardian.co.uk/business/2013/feb/05/glaxo-smith-kline-publish-clinical-trial-data

    I’m not sure I understand this bit;

    GSK said it will “publish CSRs [clinical study reports] for all of its medicines once they have been approved or discontinued from development and the results have been published”. It will eventually lead to the publication of all trial data dating back to the formation of the company in 2000 when Glaxo Wellcome merged with SmithKline Beecham.

    Sounds like they are still only publishing favourable results at the moment. “Eventually” is a bit of a vague term.

    fizzicist
    Member

    or discontinued from development

    Sounds like they are still only publishing favourable results at the moment. “Eventually” is a bit of a vague term.

    Nope – they’re said they if the drug is pulled from development, they’ll still publish the trials data.

    All bollocks really – Roche appear to be carrying the can for governments spunking a lot of money on unproven medicines. I’d much sooner have greater transparency on government spending and the value therefrom.

    batfink
    Member

    Most companies do this anyway, look at clinicaltrials.gov.

    The issue with “publication” is the fact that this currently (generally) means publication in an independent, peer reviewed scientific journal.

    If your trial didn’t show anything interesting, the chances of a high-profile journal agreeing to publish it is pretty slim. By the time you find a journal willing to run an article that says: “we did a trial, but it didn’t show anything interesting because of some complicated assumption about response rates in the stats plan, that later proved to be incorrect” the journal is so small, that the company gets accused of trying to bury the results in some backwater journal.

    I know it’s not a very popular thing to say…. but clinical trials are incredibly highly regulated. Most of the Constant Gardner stuff that people come up with is just tillfoil hattery

    bwaarp
    Member

    I know it’s not a very popular thing to say…. but clinical trials are incredibly highly regulated. Most of the Constant Gardner stuff that people come up with is just tillfoil hattery

    I dunno…. there have been a few high profile cases of publication bias. As of now it can be a right pain in the arse to get hold of unpublished negative data, stuff ends up being listed on Cochrane etc and then you have to email the professors/companies etc and half the time they seem to be unwilling to send you anything.

    Maybe the fact that a lot of the big publications earn money from reprints of positive results… has a lot to do with the fact that they don’t like publishing negative results.

    In the end there has been more than one occasion when the validity of treatments derived through RCT’s has been called into question by a good meta-analysis….. publication bias helps to muddy the ability of a researcher to pool decent data and try to find an accurate picture of the outcome of various RCT’s.

    I’ll post some more coherent thought’s when I don’t have eye strain and it’s not 2:30am.

    bwaarp
    Member

    Before you consider turning to the dark side and going all postmodernist… here was a nice commentary on the above journal article I read a while back.

    http://saveyourself.ca/articles/ioannidis.php

    You also have to consider when things apparently dont work but people swear by them anyway – glucosamine and evening primrose oil are two that spring to mind.

    I spend a lot of my day reading research papers – and sometimes I feel I could find papers to back up or dispute most things depending on which way we are trying to argue something.

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    I know it’s not a very popular thing to say…. but clinical trials are incredibly highly regulated. Most of the Constant Gardner stuff that people come up with is just tillfoil hattery

    Have you read any of the Constant Gardner stuff or Ben Goldacre’s work?

    david jey
    Member

    Hello, your friendly evidence-based medicine researcher here. Probably best if you go read Ben Goldacre’s book, as he’s a lot more lucid than me, but just to counter some complacency:

    look at clinicaltrials.gov

    A classic example of Pharma going ‘ooh look, we fixed the problem’ with some lax regulation.

    I don’t know what % of trials get registered, but if they do, what was originally published on clinicaltrials.gov (the protocol – saying basically ‘this is how we are going to do the trial, thee are the key results we will report’) frequently gets cheerfully ignored. I’m writing up a classic example of this at the moment where one of the things they originally said they’d measure (the outcomes or endpoints), didn’t really work, and gets merrily brushed under the carpet in the dossier sent to us by the pharma company. Even the peer-reviewed paper its written up in lets them get away with this. Nobody polices any of this, and companies (in my opinion) don’t get enough of a kicking for doing it (well, they do in the reports I write :twisted:).

    By the time you find a journal willing to run an article that says: “we did a trial, but it didn’t show anything interesting because of some complicated assumption about response rates in the stats plan, that later proved to be incorrect” the journal is so small, that the company gets accused of trying to bury the results in some backwater journal.

    The journals are admittedly part of the problem, but companies are, in my opinion, just as likely to quietly ‘forget about’ trials like this. Publication bias is probably the single biggest problem with EBM at the moment – hence that is where the efforts of AllTrials are being devoted.

    b r
    Member

    I’d much sooner have greater transparency on government spending and the value therefrom.

    This.

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