Clincial outcomes definitely the way forward - surrogate markers irrelevant if clinical changes proven (who cares if amyloid decreases 6% if cognitive/executive improvements confirmed??). IS a lot in the medical press at the moment r.e. approving drugs on surrogate markers only - is a contentious topic.
The issue will again be trial design, appropriate patient selection, and end points. Duration will be important, but much higher numbers will be of more importance given heterogeneity of the population being studied - want enough participants to be more representative of 'real world' patient population. Biomarkers will of course be included, but should be secondary rather than primary in interest.
Unforunately more patients = more cost!!
... so sorry, page-46
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