I've beem seeing a number of phase ones lately with very sick patients. But, you have a valid point. Efficacy will only be seen if they run the trial on sick patients. That would be my choice to do. It seems FDA is leaning toward that these days. There's a lot of pressure to get these drugs to market faster when they are geared towards the very ill.
Offhand, I can think of one now that's in a phase I oncology study using stage 4 cancer patients. Rules are changing at the FDA
In Reply to 'BeSeeingYou_No6'
Phase I trials, as a rule, use healthy volunteers.
Therefore, evidence of efficacy at that stage is unlikely.
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