Comment Phase 1 is a super low safety bar to clear. (Score 1) 40
Phase 1 trials can consist of as few as twenty subjects, although fifty is more common. It's basically there to make sure you don't kill or injure hundreds of test subjects in the larger trials with the dosage and protocol you intend to use. Only about a quarter of drugs which are rejected as unsafe are rejected at Phase 1. There have been drug trials halted because they killed dozens of people *in phase 3*.
Ultimately just 10% of drugs that pass Phase 1 get approved. The rest are either too dangerous or too ineffective.
The compassionate use exception carved out by the Federal Try Act is specifically targeted at people who have little or nothing to lose. It kills a few people who were going to die anyway, but in a few very rare cases it may have saved a few individuals. So you can argue from a utilitarian standpoint that it's ethical to make this exception for terminally ill patients because the exception does more good than harm. But extending the exception to people who aren't terminally ill will do more harm than good, just going by the number of treatments that prove unsafe *after* Phase 1.