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BaLahKie t1_ixwrbry wrote

Reply to comment by H2AK119ub in Brain cancer vaccine succeeds at prolonging survival in Phase 3 trial by Sorin61

Maybe this is a dumb question but why would you need a placebo for something like this? A person can’t really have a placebo effect where they think they’re getting better here right? It’s either improving or it’s not, like it’s tangible evidence you can track.

Or am I misunderstanding the point of placebos?

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H2AK119ub t1_ixwrw26 wrote

Your control arm in a clinical trial can be placebo, standard of care (SOC), watch and wait, or a combination. The FDA has approved first in class medicines in high unmet need populations using ph1, single arm, non-randomized/blinded trials; they have stated recently they will probably do this no longer which is causing a big stir in pharma/biotech space. The DCVAX trial was plagued by many issues. Pseudo-progression of patients being a major one. They had to change the efficacy readout from PFS (time to disease progression) to OS (death) because they could not accurately readout from MRI's if people were getting better due to pseudo-progression. This is probably why the trial was so long.

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BaLahKie t1_ixwsfxe wrote

As someone who came here from the Reddit news section, I appreciate your reply and you used a lot of complex jargon so I assume you are correct

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H2AK119ub t1_ixwsmu6 wrote

LOL. The FDA will approve the drug if they believe it provides a meaningful clinical benefit to patients. That's all that matters.

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