65K cases of H&N cancer will be diagnosed in US this year. Canada has roughly 10% of the number and EU 30-50 % . Those are population based estimates.
Powered ,well design ,multicenter ,multinational,"cross over" design ,phase III trial needs 200-500 patients in each arm of the trial if not less ( trial statistician will pre-calculate this).
With interim ( 50% accrual number of patients) analysis, it should be a quick trial to conduct , no longer than 6-12 month IMO.
And I am not surprised that IPIX looking for EU to participate rather than some other countries where data collection and validation and/or patient compliance could be a major issue.
I also have a feeling that cooperation agreement will come from European BP rather than US based BP although I could be wrong about it.
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