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>> • 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?

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> 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.

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> 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.