A
Story
Clinic-in-the-loop
> 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.

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.