Biotech Values

[jprad]

Clinical trial patient population guidelines

Are there any published standards/guidelines when in comes to the number of patients that should be included in a phase I, II or III trial?

I've encountered a good bit of variance in the sizes of populations for some of the trials I've read up on and wonder if there is anything to go by on this.

My main concern is with those trials, particularly with some cancer trials that, at least from a statistical POV, appear to be too small to draw any sort of valid inference from the results.

TIA.

John