I agree, but at least they are randomized. Mark Ratain, the arguable father of this trial design (or at least its biggest promoter) argues the enrichment is a byproduct but the important thing is tohave some randomization to help design the Phase III trials.
If you ever get a chance to chat with him about this design, it's worth the conversation. He's a great guy and one of the very few practicing clinicians (he's a hematologist) I've met who really understands statistics.
Unless otherwise indicated, this is the personal viewpoint of David
Miller and not necessarily that of Biotech Stock Research, LLC.
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