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Europe votes for clinical trial transparency

alltrials.net

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Re: Europe votes for clinical trial transparency

#21

Post by ekianjo »

andygates wrote: post #19
ekianjo wrote: post #12

Earlier quoted context omitted.

People who take part in trials usually dont care about the science, they take part in it because all the other treatments failed and they are willing to try something new. That's their main incentive, at least for life threatening diseases.

Not really true. Phase 1 (safety and tolerance) trials will be done by any old berk. And I've entered trials because yay, science, even if I have a disease that's treatable by an existing clunky method.

Oncology phase 1 trials are made on cancer patients only, so no, your statement is not 100% correct.

Plus, phase I trials are really limited in size, so they are meaningless versus the total population of people who go on clinical trials for phase 2 and 3 - and these are patients always.

Re: Europe votes for clinical trial transparency

#22

Post by ekianjo »

bildung wrote: post #20
ekianjo wrote: post #15

Earlier quoted context omitted.

Nowadays drugs work in tandem with biomarkers, so how do you explain what a EGFR mutant individual mean to a layman who has no knowledge about genetics and mutations ? You'll end up with "Drug A works better than B for EGFR wild type mutations but no different for other subsets". And? Is the layman supposed to understand what it means like that?

> Nowadays drugs work in tandem with biomarkers, so how do you explain what a EGFR mutant individual mean to a layman who has no knowledge about genetics and mutations ? You'll end up with "Drug A works better than B for EGFR wild type mutations but no different for other subsets". And? Is the layman supposed to understand what it means like that? Of course the layman is not supposed to understand that, that is no ex…

I see what you are aiming at, but the conclusion of clinical trials is almost never that simple. Drug A works better than B is a matter of statistical significance, of patient selection (history, previous treatments, genetics), and you can still register, nowadays, drugs versus placebo as comparators. So the issue of comparing two drugs together remain where no clinical trial to compare them in parallel exists. So you'll end up in these situations with : "Drug A works better than Placebo on X population" and "Drug B works better than Placebo on Y population", and the poor layman will be left on his own to understand how the X population is different from the Y one, and what to make of the results when it comes to comparing A and B.

In other words, it won't help laymen in the end.

At one point, if you really want to understand the clinical trial results, you need to go in details, and laymen won't be able to do that. So I'm not sure what they are trying to accomplish here.

Plus, you don't need that laymen language in the first place. Isn't that the job of journalists who cover scientific discoveries ? I'm afraid we hit another hurdle here, with the deplorable state of clinical trials results reporting in the general public by the media. That says a lot about what you can expect from laymen in terms of scientific comprehension.

Re: Europe votes for clinical trial transparency

#23

Post by [deleted] »

srean wrote: 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…

[deleted]

Re: Europe votes for clinical trial transparency

#25

Post by pjc50 »

barking wrote: 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).

Re: Europe votes for clinical trial transparency

#26

Post by Alex3917 »

srean wrote: 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…

In the US you need two trials showing that a drug is effective, but you can have an unlimited number showing that it's not effective. Also it doesn't need to be shown to be effective against a disease, it can just be effective at reducing some number that correlates with a disease. And you don't need to show that it's effective in the longterm, only for up to 6 weeks - it could make the disease dramatically worse in the longterm, and that's fine even if the drug is meant for longterm use.

There are some rules trying to get all new trials registered, but the rules aren't followed at all and the FDA doesn't enforce them.

Re: Europe votes for clinical trial transparency

#27

Post by bildung »

ekianjo wrote: post #22
bildung wrote: post #20

Earlier quoted context omitted.

> Nowadays drugs work in tandem with biomarkers, so how do you explain what a EGFR mutant individual mean to a layman who has no knowledge about genetics and mutations ? You'll end up with "Drug A works better than B for EGFR wild type mutations but no different for other subsets". And? Is the layman supposed to understand what it means like that? Of course the layman is not supposed to understand that, that is no ex…

I see what you are aiming at, but the conclusion of clinical trials is almost never that simple. Drug A works better than B is a matter of statistical significance, of patient selection (history, previous treatments, genetics), and you can still register, nowadays, drugs versus placebo as comparators. So the issue of comparing two drugs together remain where no clinical trial to compare them in parallel exists. So yo…

> I see what you are aiming at, but the conclusion of clinical trials is almost never that simple.

Yes, that's the problem with study subjects as complex as humans :) My academic background is in educational science and things are even fuzzier there: there never is a simple treatment->result relation because the persons receiving treatment reflect on that treatment, they are an active part in it.

> In other words, it won't help laymen in the end.

I think I know what you're meaning, but that's the point where I disagree: In my opinion this is no either/or situation but rather a question of relative amount of insight that can be given to laymen: Currently they will usually understand 0% of the scientific abstract. If we assume that a laymen's version of that abstract loses 80% of the information but is 100% understandable, that would still be a win.

> Plus, you don't need that laymen language in the first place. Isn't that the job of journalists who cover scientific discoveries ?

Absolutely, as journalists are already used to do exactly that. In practice the result will probably be exactly that: the institution will have science journalists who will produce these laymen's abstracts.

Re: Europe votes for clinical trial transparency

#28

Post by refurb »

srean wrote: 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…

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.

That is not correct. When you submit an NDA to the FDA, you need to include every piece of clinical trial data you've obtained so far. This includes trials that you've either ended early or failed to show any effect at all.

The FDA doesn't look kindly upon a company that hides any clinical trial data.

How many years exactly does one need to subvert the market so that a satisfactory level of innovation is maintained ?

We have some data on that, but we can't predict the future. I can't find the stat right now, but only about 1 in 3 drugs approved by the FDA actually produce an overall positive return.

Re: Europe votes for clinical trial transparency

#29

Post by refurb »

Alex3917 wrote: post #26
srean wrote: 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…

In the US you need two trials showing that a drug is effective, but you can have an unlimited number showing that it's not effective. Also it doesn't need to be shown to be effective against a disease, it can just be effective at reducing some number that correlates with a disease. And you don't need to show that it's effective in the longterm, only for up to 6 weeks - it could make the disease dramatically worse in…

Wow, there is a long that is incorrect in your comment.

1. You are right that typically you need two registrational trials for approval and yes you can have many trials that show it doesn't work.

2. You are incorrect that you don't need to show it works against a disease. Sometimes you can show that you are impacting a biomarker (which I assume is what you mean by "some number"), but there must be evidence that changing the biomarker impacts the disease. Without that evidence you will not get approval.

3. You are incorrect you only need to show its effective for up to six weeks. If that were true, why would drug companies be running multi-year trials for cholesterol drugs? You typically need to show its effective for however long the drug is taken, but a follow-up period is also required.

Re: Europe votes for clinical trial transparency

#30

Post by refurb »

fit2rule wrote: post #2

This is great news - no more pharmaceutical profit projects getting pushed to the forefront, only to discover a few years later that the adverse affects were buried in 'company proprietary confidental' reports .. makes it safer to live in Europe!

The EMA should work on discovering the drugs that already have publically reported serious side effects. It took the EMA how long to pull Mediator?
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