SIRT versus TACE: sample size is a false excuse for not doing a trial @ILCAnews #ILCA2012

Yesterday it was once again asserted that a clinical trial comparing TACE to SIRT for eatment of HCC was too hard becuase the sample size would be too large. It was estimated that 1000 to 5000 patients would be required. At the same time it was implied that SIRT was ready for routine use on the basis of the numbers treated already. If such large numbers are needed it is hard to assert that the company and the KOLs truly believe that SIRT is significantly more effective – the larger the effect size the smaller the sample size. 5000 patients might represent the sample size for an equivalence trial. If so then I guess we are asked to assume equivalence to TACE without the trial – and yet there is equipoise.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s