RE: AACR 2024 preview – “cancer vaccines” primed to underwhelm14 Mar 2024 16:31
One of the risks with the uncontrolled trail is that the doctors involved, through a form of unconscious selection bias, put their 'healthiest' patients on the trial (e.g. patients who haven't had so much treatment that their immune system has become significantly weakened). This could lead to the results being skewed as the trial participants are those that would have responded well to the CPI's on their own. This IMO is one of the reasons that in a small uncontrolled trial it is difficult to be sure exactly what difference the drug has made compared to the performance of CPI's on their own. This bias effect would be eliminated in larger controlled trials, which may well be why we see trials where the drug appears to have had a positive impact in phase 1/2 but then fails in phase 3.
Having said this, the results so far have been so good that I'd be very surprised if SCIB1 wasn't having a materially positive impact.