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Europe votes for clinical trial transparency

alltrials.net

31–40 of 46 posts

Re: Europe votes for clinical trial transparency

#31
post #24

Another popular decision by our MEPS just in advance of the EU parliament elections this summer. Next comes mom and then apple pie.

Another excellent decision made by the MEPs that the general public will simply not give a shit about. Your cynicism is too high. Votes for "tax the right", "throw out the immigrants", "abandon the EU" are popularism. Good science and technology votes stand by themselves.

Re: Europe votes for clinical trial transparency

#32
post #24

Another popular decision by our MEPS just in advance of the EU parliament elections this summer. Next comes mom and then apple pie.

Another excellent decision made by the MEPs that the general public will simply not give a shit about. Your cynicism is too high. Votes for "tax the right", "throw out the immigrants", "abandon the EU" are popularism. Good science and technology votes stand by themselves.

Maybe your right but to my mind there's been a suspiciously high level of superficially praiseworthy pronouncements emanating from Strasbourg just lately.

Given the limited powers of the parliament do they carry any more weight than politicians' pre-election promises?

I don't know where you live 3 billboards on my way to work are now taken up with advertisements on behalf of our local MEP. She had been all but invisible previously.

As I said in a comment lately she has recently been on the radio here claiming credit for another measure that promises much but has been criticised for being easily sidestepped.

Re: Europe votes for clinical trial transparency

#33
post #4

> • Require that a summary understandable to a lay person of what was found in the trial is published on the register. Good luck with that. Explaining complex cellular mechanisms to a lay person without any scientific nor statistical background is a very difficult task. When you consider modern medicine, you need basic knowledge in genetics, biochemistry, biology, proteins, drug formulation, pharmacology, pharmadynam…

Albert Einstein said something along the lines of if you can't explain a concept to your grandmother, you don't know it well enough. I'm sure he didn't have a molecular biologist with a Ph.D. kind of grandmother in mind.

You can explain everything if you have the patience and will to break it down to pieces for others to understand.

Re: Europe votes for clinical trial transparency

#34
post #4

> • Require that a summary understandable to a lay person of what was found in the trial is published on the register. Good luck with that. Explaining complex cellular mechanisms to a lay person without any scientific nor statistical background is a very difficult task. When you consider modern medicine, you need basic knowledge in genetics, biochemistry, biology, proteins, drug formulation, pharmacology, pharmadynam…

They'll have prepared material already explaining the purpose of the trial for the purpose of obtaining informed consent. The text for the result will have to be written up but even that will be mostly boilerplate.

Re: Europe votes for clinical trial transparency

#35
post #33
post #4

> • Require that a summary understandable to a lay person of what was found in the trial is published on the register. Good luck with that. Explaining complex cellular mechanisms to a lay person without any scientific nor statistical background is a very difficult task. When you consider modern medicine, you need basic knowledge in genetics, biochemistry, biology, proteins, drug formulation, pharmacology, pharmadynam…

Albert Einstein said something along the lines of if you can't explain a concept to your grandmother, you don't know it well enough . I'm sure he didn't have a molecular biologist with a Ph.D. kind of grandmother in mind. You can explain everything if you have the patience and will to break it down to pieces for others to understand.

Yeah I'm sure his grandmother had no problem understanding the general theory of relativity. Do you have other end all discussions quotes to share?

Re: Europe votes for clinical trial transparency

#36
post #24

Another popular decision by our MEPS just in advance of the EU parliament elections this summer. Next comes mom and then apple pie.

Well, yes, elected politicians doing things their constituents want so that they'll get re-elected is surely the point of the system.

Re: Europe votes for clinical trial transparency

#37
In the US, this is already present, to some extent, with FDAAA 801 [1], which requires that all clinical trials be registered before they start. Missing things like required publication and the "human-readable" digest, but the absence of data can be factored in by the FDA when considering approval -- that is, studies that terminate without reaching a finding can be considered weak indicators of problems, and in the long run, potentially point to organizations or individuals who might be suppressing negative results.

Even required publication is no cure for this; a result saying "we inadvertently broke the blind" or "the protocol was poorly implemented" is perfectly possible even in good faith.

[1] http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa

Re: Europe votes for clinical trial transparency

#38
post #18

As far as I know, US laws require that the `x` number of trials demonstrate the effectiveness of the drug and failured dont need to be reported. But this does not make sense to me, and I welcome the European laws. In the US system, even if I have a coin biased badly against coming up heads, if I toss it enough number of times I will get `x` heads. The tosses cost money and that is then used to justify the patent syst…

> even if I have a coin biased badly against coming up heads, if I toss it enough number of times I will get `x` heads.

I'm pretty sure a "trial" is a statistically significant study of many patients. So in this case, your analogy to the coin is flawed. A better analogy would be x groups of 10,000 coin flips, and to take the average of each group in x. Now, no such average would favor the less probably side of the coin.

Re: Europe votes for clinical trial transparency

#39
post #24

Another popular decision by our MEPS just in advance of the EU parliament elections this summer. Next comes mom and then apple pie.

As others here have alluded to the powerlessness of the MEPs allows them the freedom to do the right thing.

Re: Europe votes for clinical trial transparency

#40
post #25
post #24

Another popular decision by our MEPS just in advance of the EU parliament elections this summer. Next comes mom and then apple pie.

The EP is actually quite good at producing the right decisions, especially when the public remember that it exists and lobby them over this issue. Unfortunately it's the weakest of the legislating institutions (Parliament/Commission/Council).

Yes. I'd like to have EU institutions which look more like "normal" democratic systems, and greater power for the EU parliament. But it's still a lot better since the Lisbon treaty.
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