Clinical failure rates over the decades: yikes

perpetuallunch

This is completely unsurprising, and this: But let’s think about that 91% failure rate for a moment. When I bring this up in presentations, I invite the audience to consider what the auto industry would look like of 91% of new car designs proved unable to roll out of the factory, or if 91% of new airliner models were unable to leave the ground Is an utterly irrelevant comparison. For physical thing we have engineering, and the practical application of the trades and craft, trial and error. For modern medicine, we're only just starting to come out of the wild west era. Or perhaps slightly further along than that.

levocardia

I'm actually surprised it isn't going up over time. That is naively what you would expect as the low-hanging fruit is plucked. So the fact that it's been stable is probably a sign that scientific advances are roughly keeping pace with the (presumably) increasing challenge of finding ever more targets for drugs.

AbsurdCensor

As someone who works in research, this isn’t surprising at all. It’s hard to find something that treats (well most often reduces symptoms) of a particular disease. It’s even more difficult to find something that is also safe at the dose level it takes to treat said disease. Are there faster ways to do this? Probably not. AI is only going to help out so much, just like automated drug screening only helped so much since its introduction in the 90s.

calf

Why does he conclude there is no alternative? He already argued this would be strange in other disciplines. So reform it.

debo_

There's an alternative that is slowly emerging. Many clinical trials "fail" but the drug candidate in question works really well for identifiable subsets of the participants. Right now pharma companies won't bother pursuing those drugs because they can't market it broadly. But it's still possible these drugs could help people in the future.

jcims

Roughly equivalent to the percentage of startups that fail. Lower numbers don’t mean we’re doing better, it means we’re trying less.

roenxi

> I’m fond of saying that the most important single statistic about the drug industry is the clinical failure rate, which is (by any reasonable standard) appallingly high. He starts off on the wrong note, there is nothing at all wrong with a high rate of clinical failures. If anything, the reasonable argument standard might be that this rate is too low. It implies researchers are trying things that they expect to have a 10% chance of working out. That means we're missing out on all the cures and techniques that have a 1% chance of working out but but nonetheless do work. Failed attempts cost society nearly nothing and successes will have compounding benifits for, y'know, lets optimistically say the human race survives for centuries. 1% or 0.1% success rates sound completely reasonable with that sort of lopsided risk profile. There isn't much of a reason not to try anything and everything that has the faintest chance of helping and see what happens.

tchalla

I’ve been hearing for 10 years now on how “AI” will change this clinical rate. It’s now like the “This is the year of Linux” prediction meme. And like Derek has mentioned multiple times you can’t statiscialise biology. I don’t think many people get it so we have tech bros like us throw AI at data.

Fomite

Doing hard things is hard.

arjie

Can’t agree with the premise. It seems that through changing regulatory regimes and technology a 1 in 10 chance is the economic optimum for this. Interesting stability, certainly, but I’d expect that as technology improves success rate, funding increases until the marginal project is unprofitable. The better we get at doing things, the more ambitious we get. As an example, we can keep babies alive much earlier in gestation, so we try harder if they’re earlier than we would before. We should expect a homeostatic equilibrium between our skill and our ambition.

Plasmoid

The author, Derek Lowe, also writes the hilarious Things I won't work with series ( https://www.science.org/content/blog-post/things-i-won-t-wor... )

refurb

As someone who used to work in pharmaceutical R&D, the important thing to remember is the hurdle to get over hasn’t remained constant. The FDA has gotten significantly more strict in its review than it was in the 1960s. A good example is hERG inhibition as an off-target effect. It’s a receptor on heart muscles and will result in QT prolongation and potential arrhythmias. It wasn’t discovered until the 1990s. Now every molecule is screened and many are dumped. The impact can vary but there are tons of drugs on the market now that are hERG inhibitors (many discovered after the fact). It’s a good example of the increased rigor that the FDA applies to everything they review that past trials never had to face.