This captures the fundamental issues of incentives in this sort of thing. It takes a lot of money to run trials, and regardless of what is said about risk and w

This captures the fundamental issues of incentives in this sort of thing. It takes a lot of money to run trials, and regardless of what is said about risk and what participants agree too, anyone suffering an adverse effect has a strong incentive to resort to the legal system. The FDA system is the only way to get therapies to large numbers of patients. But it isn't the only way to get therapies to patients period, and it has serious flaws. The FDA is risk averse to the point of suppressing progress. The costs have doubled in the last ten years for no good reason. There is a desperate need for a less heavy handed, more distributed, faster system that favors pace of progress - but all attempts to build it will run into this problem of incentives. The organizations running trials are targets, and people will respond poorly to being struck by risk no matter what they sign or are given to understand up front. Non-profits may work for low-cost treatments, such as repurposed cheap-to-manufacture compounds from the drug databases (e.g. senolytics), but some types of therapy genuinely do require an organization with tens of millions in the bank to sustain development. How do they proceed if not via the FDA?