Al's Comment:

 

The presentation on the DCVax clinical trial for glioblastoma, which was showcased at the ASCO meeting yesterday, brought attention to the use of an external control group in the trial. This aspect of the trial has been the subject of much criticism, particularly from individuals on the internet. However, I am of the belief that external control groups, when utilized correctly, can potentially offer more beneficial insights than a randomized control.

 

There have been several instances recently where long-running trials did not stratify by biomarkers that were unknown at the time the trial was initiated. These biomarkers were later discovered to significantly influence outcomes, potentially affecting the overall results of the trial. The purpose of randomization is to theoretically distribute these different prognostic factors evenly between the treatment and control groups. However, in these instances, the randomization failed to achieve this balance.

 

By using external control groups, we can account for every known prognostic indicator. Furthermore, if a new prognostic factor is identified before the data is reported, we can recreate the external control group taking this new factor into account. This methodology can also be more ethical, as it prevents wasting a patient's life by administering a placebo, or a standard of care that does not cure the disease.

 

The presentation also detailed the mechanism of action of DCVax. In one case, they found that DCVax targeted over 11,000 targets, a remarkable finding considering that many other vaccines currently in trials target only one to six targets. This suggests that DCVax could potentially be more effective due to its wide range of targets.

DCVax®-L: Mechanism of Action, Immunological Effects, and Clinical Trial External Controls Methodology