European Universities Dismal at Reporting Results of Clinical Trials (nature.com) 65
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.
"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.
Re: They probably (Score:1)
In between 3 hour lunch breaks and two month vacations, I would find it shocking if they ever released anything.
Re: They probably (Score:1)
Right, some of it has burned down.
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I expect it is probably due to some ambiguity in the law combined with the lack of any effective enforcement.
Clinical Trials can go on for a long time, sometimes for generations. For many trials, they may not have final results, but a wealth of preliminary results. Also being that such results need to be officially reported, there probably is a lot of time, doing extra review to make sure all the I's are dotted and the T's crossed.
So the question is Drug X safe? Well we have been testing it for 30 years an
The problem with overwhelming regulation (Score:2, Insightful)
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.
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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.
Great example of what I mean, thanks for raising (Score:2, Insightful)
Example, our tax code. It is quite enforceable
You give the tax code as an example and say it's enforceable. Yet we see countless examples of people who flaunt tax codes and nothing happens. They are so complex that with the proper amount of effort applied very large companies can skirt almost anything, against the actual intent of the tax codes. How on earth can you possibly claim it is not too complex when that kind of runaround is even possible?
That was true long before Republicans came to power agai
Re:The problem with overwhelming regulation (Score:5, Insightful)
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.
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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
Yes, exactly what I am saying (Score:1)
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?
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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.
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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)
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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
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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
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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
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Depends on the university. The LSE, for example...
No Billion Dollar Fines? (Score:2)
I bet none of those universities get multi-billion dollar fines for not following the rules.
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Not sure why that should matter. Just take it out of any public funding received.
Cui Bono (Score:4, Insightful)
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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.
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Is publication difficult?
Not enough time to get publication ready?
A different issue AC?
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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.
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The results were delayed ... (Score:5, Funny)
... 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)
Unrepeatable results (Score:3)
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.
Eminence-based instead of evidence-based medicine (Score:2)
IMHO, the medical profession is today about where astronomy was shortly after it forked off astrology.
Good (Score:2)
It goes against our feels (Score:2)
The results of the clinical trials are offensive.