NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

I have always believed the partial halt was driven by German ethics in trials as they have the NAZI history with experimentation and take that stuff very seriously. One of my very early posts here was on that subject and my conviction that it was driven by a German ethical concern for placebo patients having their treatment delayed and therefore being potentially harmed by that delay.

biosectinvestor,

I agree. This is also my opinion.

The use of a placebo in clinical research was a topic of debate in the medical community in Germany at the time of the halt on recruitment.

At that time there was a discussion in Germany whether continuing a placebo designed study to its designed end point could be a legal problem according to the German national criminal law, when the advantage of the experimental treatment against the placebo is clear enough before reaching it.

The German authorities justify a placebo controlled trial under the condition that “the duration of the placebo treatment is as short as necessary”.

Q6: “How do you interpret paragraph 32 of the Declaration of Helsinki?”
Germany refers to the “compelling and scientifically sound methodological reasons” [2] which could justify a placebo control under the condition that “the duration of the placebo treatment is as short as necessary”.
https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-018-0262-9

So, continued assignment of subjects to placebo is unethical once there is good evidence to support the efficacy of the trial therapy.

I know that in the DCVax-L trial the placebo patients got “SOC + placebo” but it would not surprise me that Germany had a similar recommendation for the “placebo + SOC patients” in our trial during the summer of 2015.