[ekianjo]

> • 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, pharmadynamics, toxicity, clinical studies design, to have a proper understanding of what a study means. We're not talking about aspirin class of medicines anymore, and more and more drugs are now in the class of large molecules.

[bildung]

>> • 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. What has to be explained is the result of the trial.

[ekianjo]

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?

[bildung]

> 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 <test method>."

[ekianjo]

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.

[bildung]

> 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.

[arethuza]

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".

[ekianjo]

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.

[andygates]

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.

[ekianjo]

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.

[arethuza]

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

[ekianjo]

All oncology trials. And thats already A LOT.

[arethuza]

That's not actually answering my question. :-)

[fit2rule]

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' ..

[sveme]

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.

[ekianjo]

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.

[atmosx]

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.

[ekianjo]

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?

[atmosx]

> Yeah I'm sure his grandmother had no problem understanding the general theory of relativity.

Here[1], try and see if you can understand it. I'm sure you can, I'm sure your grandmother can too. Also if you have any specific questions about pharmacology, molecular biology or anything related feel free to ask, I might be able to come with a reasonably simple answer.

[1] https://www.youtube.com/watch?v=YgpD4XZP0uM

[Mvandenbergh]

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.