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EU Education Science

European Universities Dismal at Reporting Results of Clinical Trials (nature.com) 65

Posted by msmash from the reality-check dept.
Analysis of 30 leading institutions found that just 17% of study results had been posted online as required by EU rules. From a report: Many of Europe's major research universities are ignoring rules that require them to make public the results of clinical trials. A report published on 30 April found that the results of only 162 of 940 clinical trials (17%) that were due to be published by 1 April had been posted on the European Union's trials register. The 30 universities surveyed are those that sponsor the most clinical trials in the EU. Fourteen of these institutions had failed to publish a single results summary. If three high-performing UK universities are excluded from the figures, the results of just 7% of the trials were made public on time. Campaigners say the resulting lack of transparency harms patients by undermining the efforts of doctors and health authorities to provide the best treatments, slows medical progress and wastes public funds.

"Major universities in continental Europe are clearly not investing the effort required to meet their ethical, scientific and regulatory obligations," says report author Till Bruckner, of the UK-based transparency campaign group TranspariMED. A 2004 EU law that came into effect in 2014 requires study sponsors to publish summaries of a trial's results on the European Union Clinical Trials Register (EUCTR) site within 12 months of the trial's completion. Updated laws on clinical trials that are not expected to become legally binding until 2020 specify that there should be penalties for institutions that don't comply with the rules.
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European Universities Dismal at Reporting Results of Clinical Trials More

European Universities Dismal at Reporting Results of Clinical Trials

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  • The problem with overwhelming regulation is twofold.

    First, with so many regulations, you could make the case that a lot of groups simply don't even know they NEED to comply.

    Some groups may know and chose not to comply, which leads to the second issue...

    If there are too many regulations, you ca't possibly police them - so everything becomes selectively enforced, which leads to corruption.

    • Re: (Score:2)

      by Luthair ( 847766 )

      I would hazard that the issue is that researchers have to chase funding for the next thing before they finish the current one. We've had stories on Slashdot about researchers being fired for not having a high enough publication output. I also recall a similar story about many US researchers also not following open access requirements

      There is an easy solution - don't grant more funding until previous research is made available.

    • Re:The problem with overwhelming regulation (Score:5, Insightful)

      by jeremyp ( 130771 ) on Wednesday May 01, 2019 @03:57PM (#58523708) Homepage Journal

      This is not "overwhelming regulation". This is basic good practice. If you don't publish your results - positive or negative - the published literature develops a skew.

    • There's another issue with these regulations in particular that also happens pretty often: there is apparently no penalty for violating this law. WTF is the point of the law then? Seriously, what's the point of it? According to the summary there are updated laws coming into effect in 2020 that will add penalties, but until that actually happens don't expect any of these Universities to put any effort into complying. Why would they?

      The other problem you run into are penalties that technically exist but are s

      • there is apparently no penalty for violating this law.

        Right, that falls under the "no way to police" aspect I mentioned. There probably is no penalty because they had no way to enforce a penalty.

        Why have any law then? To show they tried, even if there is no effect.

        Meanwhile it's just another thing for a business to have to try and comprehend - what is the punishment for violation of any given rule they fall under - or is there any punishment?

      • It's 100% illegal to make a false DMCA claim against someone's work,

        It's not, not even slightly. It's actually VERY narrowly defined.

        If you claim work B has violated copyright A, it's illegal IF you don't represent the owner of A. You can be making up whatever shit you like against B.

      • Re: (Score:2)

        by AmiMoJo ( 196126 )

        When the need isn't pressing this is the way new rules are developed in Europe. Introduce the rule but with no or very light penalties. See how it works, see if people comply voluntarily. Then a few years later introduce penalties appropriate to the magnitude of the problem.

        It also gives orgs and opportunity to come into compliance at their own pace, without undue burden.

        Of course it's only for things that can wait for enforcement, anything urgent gets immediate penalties.

  • European Universities Lack Idealism (Score:3)

    by dryriver ( 1010635 ) on Wednesday May 01, 2019 @03:23PM (#58523506)
    European universities in my time were stiff bureaucracies where freedom of thought wasn't greatly appreciated and people sort of go through the motions of being "academic". The student body was jaded and disillusioned, too. People who are barely 20 years old and basically operate in "just fulfill the requirements and graduate" mode, with no great aspirations or goals in life other than making a decent living after uni. Don't know what's changed there since, but back in the day, nobody was trying to change anything or make the world a better place. So medical studies not being published in a timely fashion is hardly surprising.

    • People who are barely 20 years old and basically operate in "just fulfill the requirements and graduate" mode, with no great aspirations or goals in life other than making a decent living after uni.

      Good! Almost all "people who are barely 20 years old" don't know jack shit about anything and should be at university to LEARN and get their degree, period. It turns out that the easiest way to do that is generally to "operate in 'just fulfill the requirements and graduate' mode," with as little drama or dist

      • University is a place where you are supposed to be adult enought to think critically - that means questioning things. You on the other hand seem to advocate rote learning where books are slapped in front of you and you go "this must be THE way to look at this subject". No wonder the world advances so slowly.
        • You are describing graduate school and beyond. Since the 2nd half of the 20th Century, a four-year undergraduate degree has replaced what a high school education used to be -- meaning that, without one, you're excluded from most well-paying jobs outside of the trades. I'll stand by my statement that the vast majority of people who are barely 20 years old don't know shit because they don't have enough experience yet, and they are best served by getting their degree *first*.

        • If you let a person with no experience and knowledge into a woodworking shop, they'll lose fingers or worse. The whole real world is fraught with even more peril for the unsuspecting, trusty student. These rules for behavior of teachers in a university are there for a reason.

          You can't think critically without learning first.

          No way you can find flaws in the Standard Model if you don't know at least the language that describes it - linear algebra, complex analysis, group theory and a ton of other math, which

      • Re: (Score:1)

        by AHuxley ( 892839 )
        If they had done the "Learn" part the result would be published as that is what was expected of them.
        The skill to manage a project and the time to publish would have been understood.
        Due to the quality "learning" part and having done past projects on time.
        The "learn" part would have included the ability to do the work needed and then have the ability to manage time and publish on time.
        Is it a skill problem? People cant get the results presented in time? The quality of the results?
        The tests are t

    • Re: (Score:2)

      by AmiMoJo ( 196126 )

      Depends on the university. The LSE, for example...

  • I bet none of those universities get multi-billion dollar fines for not following the rules.

  • Cui Bono (Score:4, Insightful)

    by DCFusor ( 1763438 ) on Wednesday May 01, 2019 @03:50PM (#58523684) Homepage
    Virtually all clinical trials are paid for by drug companies. If the results are bad, as is the case more often than not, there's a big disincentive to publish those results. I thought everyone already knew this, but I guess it's a function of being an old fart and forgetting I once didn't know everything already.

    • If the trial is publically-funded, OK, but if they are paid for by drug companies, why should they have to publish the results? The results are almost certainly proprietary.

        If enforced, all this will means is that the universities will not get paid to do studies at all.

      • It isn't just drug companies supplying dollars that make drug trials happen. Patients participating in the trial risk their health on unproven treatments, for the purpose of improving medical knowledge. It is unethical to suppress the trial results.

      • If you have a trial on effectiveness or safety of a proprietary drug X, then yes, the results very much do have to be public, even if the drug itself is proprietary.

  • The results were delayed ... (Score:5, Funny)

    by WoodstockJeff ( 568111 ) on Wednesday May 01, 2019 @03:57PM (#58523710) Homepage

    ... while our legal team verifies that it is in compliance with the GDPR.

    We estimate that they will complete their review in 2032.

  • So (Score:2)

    by Dunbal ( 464142 ) *
    Make funding contingent on publication. Whoops.

  • Unrepeatable results (Score:3)

    by theCat ( 36907 ) on Wednesday May 01, 2019 @04:28PM (#58523846) Journal

    I've been hearing a lot lately about the problem with "unrepeatable scientific results." The benchmark for accuracy in science is publishing your data and methods so that someone else can validate both, and maybe even conduct the experiment themselves. However, due perhaps to the rush to market, a lot of clinical drug trials are producing "results" that when tested are not repeatable. Sometimes, not even a little bit. As if the results showed no effect. So it's no wonder researchers are holding back on revealing data and methods; their new product might be shown later to be bogus.

    Medical science isn't really a science. At least, not since it became a business. Mostly the "science" part is wrapped up in the "marketing" part so that clinical results are mostly determined in advance, and the data/trials are mostly about supporting what the marketing is going to say about all that.

  • The medical profession (much unlike MINT sciences) is in many countries still far from being evidence-based. It is rather "eminence-based", and if your study result contradicts the opinion of the eminence, then the study is rather not published.

    IMHO, the medical profession is today about where astronomy was shortly after it forked off astrology.
  • Less survey says fucking "studies" reporting that eggs kill you and 6-8% higher number of deaths in 1 million people is enough to pin something on a single food item.

  • The results of the clinical trials are offensive.

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