At randomization, the pts are divided into 2 groups, SIRT vs Sorafenib
ITT--> intention to treat would look at the results at initial randomization.
Advantages--> reflects real life,, less bias
Disadvantages--> may underplay benefits, exaggerate side effects ( eg pt A decides not to proceed with treatment after randomization would still be analysed as failure of treatment)
As per protocol--> eventual treatment received; strict adherence to protocol
Advantages--> cleaner data
Disdvantages--> bias introduced ( eg unequal numbers due to cross over of patients from one group to another ).
Overall, for a non inferiority study ( as opposed to a superiority study), both analysis are required.
In this case, the standard of care is Sorafenib. It LOOKS like SIRT is non inferior to the standard of care ( ie less side effects, p value is also very low). BUT it remains to be seen if the survival is equivalent ( as the p-value is high , results may be due to chance)
Will oncologists ( my colleagues ) recommend SIRT?--> yes, as it has less side effects ( remember , these patients are in the category of advanced cancer, hence chance of cure is low. Treatment is mainly to control the disease, with the least possible side effects)
Will investors like the results? --> probable not, due to the ambiguity of the results.
I will be keeping my stop loss tight.
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