If in a trial - a misinterpretation of inclusion criteria by sites led to 10% of patients enrolled who do not meet the criteria (not a protocol violation per se, but misinterpretation of the intended inclusion criteria). These 10% of the participants were randomized and will be included in the ITT analysis - but have NO chance of benefit from the therapy. Is there any opportunity to suggest that at the end of the trial if
p> xx (‘significantly’ > 0.05) - negative
p between xx-xx (> 0.05 but not ‘too much’) - redefine p criteria for positive trials more strictly and reanalyze the data with excluding these 10% of the patients - and if the rest of the patients meet the redefined more stringent p criteria - conclude positive study
Is there such a statistical option?