3. Cost effects 3 trials.
Duh..
Yes that's why I kept it short. I presume you meant "Phase 3 trials' size". Perhaps you are drinking some excellent vino tonight ?
4. Clinical effect vs. stat sig
This is a point that David at BSR has been pounding the drums on. Running a 2000 patient trial to detect a microscopic improvement in some clinical condiction is just not impressive.
Yes, but not mentioned in the discussions here on "trial design under-powering" - and it mirrors the Proellex situation (because of Lupron being avalable and cheap).
5. Bigger trials might be bad because safety issues could outweight benifit.
Sorry, unless I misunderstand you, you lost your mind on this one.
No, you did. Designing for bigger trials means designing for smaller clinical benefit. Not good when there is a safety issue affecting risk-reward balance (ask FDA).
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