Clinic-in-the-loop | Hacker News Reader

Clinic-in-the-loop

asimov.press

23 pointssurprisetalk7 comments

> biomedical progress, especially in therapeutics, has become less productive despite staggering advances in basic science.

> the inflation-adjusted cost to bring a new drug to market roughly doubles every nine years: a trend that has held since the 1950s.

Presumably they're getting at numbers of new drugs brought to market.

I'm interested in a different metric: Quality-adjusted life years (QALYs) saved due primarily to new drugs brought to market.

Who cares if 1 million drugs come to market and they do little to improve lives? We'd prefer 10 that had more QALYs.

Useful perspective. I think viable second sources can also lower costs. They might not increase QUALYS but would probably lower the cost of existing QUALYS so that money could be spent on other needs.

I consult on clinical trials at various drug companies, and I'm broadly sympathetic to Clinical Trial Abundance Project that they talk about.

I think the authors understand that there is no silver bullet here. There is no single obstacle to better drug development--if there were, then one or more drug companies would have discovered it (for more profit) and the rest would have copied.

Of the trials I've been involved in, the most common reasons for not moving faster are:

1. Patient enrollment: For all the common diseases, there are multiple companies testing new drugs, all competing for patients. For rare diseases, the patient population is so small that, again, it is hard to recruit.

2. Molecule development: Many (most?) new drugs being tested are "me-too" drugs that are tweaks of existing, successful drugs. If it cost $100 million to test a new drug, you want to maximize your chances of success, so you are not likely to take risks. Of course, taking more risks also means risking patient lives, so no one is in a hurry to change too quickly.

My particular focus is around the information tech used to analyze the data in the trial. There are a lot of inefficiencies right now, mostly due to primitive, but well-tested, systems. You'd be surprised (or maybe not) at how much clinical trial data gets sent around in random Excel worksheets.

The cost of iteration here is so high that we will likely remain in a bioengineering winter until there is a way for individuals to iterate on these compounds in their own self-directed research. We need a ham radio equivalent for synthetic molecules.

Why aren't those types of clinical trials, enabling faster iteration speed, moved to countries with less strict regulation?

In general, drug companies do not send employees out to inject patients with drugs. That's not how it works.

Instead, they work with specific doctors at local clinics who treat patients. Those doctors agree to fill out appropriate documentation (and are paid to do so) which the drug company then uses to submit to the FDA/EMA to get approval for sale. Those doctors are considered Principal Investigators, in that they are fully responsible for patient treatment AND for reporting patient outcomes to the drug company.

All countries with sufficient, local medical expertise, also have regulations on how trials are conducted. Those regulations are different from US/European regulations, and unless you're an expert in, e.g., Chinese clinical trial regulations, you have a very steep learning curve.

this website needs to be autoflagged it's always junk science

Reply on news.ycombinator.com