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Europe votes for clinical trial transparency

alltrials.net

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Re: Europe votes for clinical trial transparency

#11

Post by fit2rule »

ekianjo wrote: 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…

But you see, this is why its ever more important to have public data available - so that people can educate themselves on these things, if they want to.

Its sort of like in the bad ol' days of computing - you used to have to know all kinds of arcane things just to be able to get some numbers crunched. Nowadays, if you want, you can look at the source for your OS .. this is the same effect that needs to happen in the pharmaceutical industry, and I for one look forward to the reduction in sheer Power over peoples Lives that the pharma mega-industry has had, as people start to realize that there is a lot of smoke and mirrors in what they're being told 'is a solution to their problems .. for $99/month' ..

Re: Europe votes for clinical trial transparency

#12

Post by ekianjo »

arethuza wrote: post #6
ekianjo wrote: 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…

It might not be possible in every case, but it sounds like a laudable goal to me. Also, what do they tell people who take part in trials - I'd be pretty annoyed if I took part in a trial and someone told me "we can't tell you because with your humble CS education you wouldn't understand it".

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.

Re: Europe votes for clinical trial transparency

#13

Post by ekianjo »

sveme wrote: post #8
ekianjo wrote: 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…

Well, a trial is not about the molecular mechanisms of a drug. It is about checking whether a drug works and whether it is better than existing drugs. So statistics. Still hard, obviously, and plenty of space for semantic whitewashing.

A trial usually tries to justify a mechanism of action. That's the least you try to do when you spend hundred of USD millions in a Phase 2 or 3 trial. And anyway even if a drug works better than another, it's almost never a black and white result, because drug safety profile usualy differ. You'll end p with a one pager result most laymen won't be able to grasp, no matter how you want to simplify things.

Re: Europe votes for clinical trial transparency

#14

Post by arethuza »

ekianjo wrote: post #12
arethuza wrote: post #6

Earlier quoted context omitted.

It might not be possible in every case, but it sounds like a laudable goal to me. Also, what do they tell people who take part in trials - I'd be pretty annoyed if I took part in a trial and someone told me "we can't tell you because with your humble CS education you wouldn't understand it".

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.

What percentage of clinical trials involve people in those kinds of situations?

Re: Europe votes for clinical trial transparency

#15

Post by ekianjo »

bildung wrote: post #10
ekianjo wrote: 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…

>> • 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. I don't think that the cellular mechanisms, or generally speaking the mode of action, are what has to be explained understandable to a lay person.…

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?

Re: Europe votes for clinical trial transparency

#16

Post by ekianjo »

arethuza wrote: post #14
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.

What percentage of clinical trials involve people in those kinds of situations?

All oncology trials. And thats already A LOT.

Re: Europe votes for clinical trial transparency

#18

Post by srean »

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 system.

One of the oft repeated justification for the absurd levels of IP protection and patent extensions that pharma enjoys is the huge cost of trials. But if huge development costs are the reason for these protections to exist, guess what, these costs will continue to remain huge. Its just self perpetuating.

Patents are primarily a preemptive measure against a hypothetical scenario. The hypothesis is that unless market pressures are cordoned off, innovation will stop. It is a believable hypothesis but not a quantitative one, and this exactly where we need a quantitative one. How many years exactly does one need to subvert the market so that a satisfactory level of innovation is maintained ? Nobody knows. In these scenario what we need is a feedback system, and pretty much the only scalable and fair apparatus that we have for such feedback on economic affairs is the market.

So rather than subverting the market, market should be explicitly and actively involved to work out this trade-off. How exactly this is to be done needs to be worked out.

There could be a futures market on patents on drugs undergoing testing: competitors can promise to buy the patent to the (drug,usecase) pair at a particular price (even if its a dud) and if the owner decides not to sell the owner pay a particular compensation. Such measures will spread the risk. There should be mechanisms for a company to raise money for testing in lieu of rights over the product.

The initial period of validity of a patent should be short, like 3~6 years, following which the patent is on the market. Entities can bid to bring the patent to public domain. The owner(s) bids to retain it. Whoever wins gets the balance. Of course the "bring it to public domain" bidders will bid less because profitability is less when its in the public domain, but market decides who gets to own it. If the owner(s) think they can still extract lots of profit from the drug, bid high. We should stop handing out blank checks without a feedback loop, that is just bad design.

Re: Europe votes for clinical trial transparency

#19

Post by andygates »

ekianjo wrote: post #12
arethuza wrote: post #6

Earlier quoted context omitted.

It might not be possible in every case, but it sounds like a laudable goal to me. Also, what do they tell people who take part in trials - I'd be pretty annoyed if I took part in a trial and someone told me "we can't tell you because with your humble CS education you wouldn't understand it".

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.

Re: Europe votes for clinical trial transparency

#20

Post by bildung »

ekianjo wrote: post #15
bildung wrote: post #10

Earlier quoted context omitted.

>> • 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. I don't think that the cellular mechanisms, or generally speaking the mode of action, are what has to be explained understandable to a lay person.…

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 explanation in layman's terms. You can make these sentences understandable by generalizing it: "We already knew before that the effect of these types of drugs is very specific to the specific genetics of a patient. Now in this trial we tried to find out what specific drug works for what specific genetic combination. The result is that Drug A works better than B for a combination that is called XY: Whether or not that applies to you can be found out by ."

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