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.