[CryptoPunk]

>>It's a nice thought, but you generally can't have patients and doctors opting-in for unproven treatments and expect the resulting data to stand up to any sort of scrutiny.

It can give much earlier indications of drug efficacy, even if it doesn't provide the proof of Phase 3 compliant studies.

The history of cancer research shows how earlier human experimentation can lead to a much shorter time between a drug being discovered, and it being proven effective enough to become a part of the standard treatmemt protocol. This shorter time to incorporation of an effective drug in standard treatments means survival for hundreds of thousands of people that would have otherwise died.

That the motivations of the parties that would be affected by the loosening of the rules are not all altruistic or even ethical is worth taking into consideration, but it can't be the only priority when crafting regulatory strategy.