Thank you for the information. It has raised some questions that I would appreciate anyone's opinion on. First, from the clinical trials gov website for this trial the following is obtained:
Chronic liver disease is classified into Child-Pugh class A to C, employing the added score from above.[1] Points Class One year survival Two year survival 5-6 A 100% 85% 7-9 B 81% 57% 10-15 C 45% 35%
Something doesn't seem to add up here. We know that the trial was only supposed to have Child-Pugh A patients and therefore the 6 volunteers whose OS and biopsy data is being discussed should have have been Child-Pugh A and have a 100% chance for 1 year survival but the OS data for all 6 was not even close to 1 year.
First question is, am I correct in how I am trying to assess the expectation of survival for our 6 volunteers based on the requirements of the trial inclusion criteria and what OS is expected based on Child-Pugh scoring?
2nd, does anyone know if it is allowable by FDA regs to take patients into a trial with a Child-Pugh score worse than the scoring criteria specified in the criteria posted in the clinical trials.gov website?