Consistency [Two-Stage / GS Designs]

posted by DavidManteigas – Portugal, 2016-10-11 11:25  – Posting: # 16721
Views: 10,248

Hi all,

I get shocked sometimes with the lack of consistency in assessments of member states which should all follow the same guidelines and made their reviews according to the current opinions of the scientific groups of the EMA. I think this happens due to lack of training in regulatory reviews and "regulatory science" in general (in Portugal, almost all of the reviewers I know are "academic") and also due to lack of resources in some agencies to have qualified reviewers for each 'specialty'.
In some countries, I believe that as long as you got a favourable opinion from an ethics committee and regulatory approval for the trial, they will consider your trial "valid" regardless of the appopriateness of the design, statistical methodology and compliance with guidelines/recommendations for design & analysis.

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