The emotional trial of clinical trials: like online dating with death risk

>The issue with the medical system is similar to the issue with prisons: It has no person that is motivated to care about it.

Why prisoners must be able to vote or you cannot claim to have a democracy

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This was not what I expected to read, and therefore much sadder to me. I had expected to see an article about the emotional strain of not knowing if you're in the control arm or the treatment arm for a late-stage trial. You know that you're in an experiment, and you might get a new drug -- or existing standard of care -- depending on a roll of the dice.

This was very different. The author is describing a mad scramble to get enrolled in a phase 1 clinical trial, and discussing the scramble as a life-or-death critical choice. Even ignoring the question of whether or not you're in the control arm, these kinds of trials have no guarantee of much of anything. It's even possible the drug itself might hurt you, because that's exactly what they're looking for in phase 1. Per the clinical trial registration for PDL1V:

> Part C will use the dose found in Parts A and B to find out how safe SGN-PDL1V is and if it works to treat solid tumor cancers.

(emphasis mine)

I don't know if the author knows this, but I can't imagine the stress of not being well-informed about the purpose of an experiment like this. And those doctors who are telling him things like "SGNTV had successfully shrunk a lot of tumors" is so maddening, if they didn't follow that with "...but we don't know what it will do in humans, because it's a phase 1 trial". It's not at all clear that they did, because of things like this:

> If I was given SGNTV, I’d have three systemic lines of therapy and be ineligible for PDL1V. And the same in reverse. Sophie’s Choice!

and later:

> A downside of all these phase 1b studies is that there’s little published data, which makes comparisons difficult. Oncologists almost never give numbers: “We dosed 10 patients, and the disease control rate in phase 1a was 50%.” Instead, they’ll be vague, but they’ll also indicate why they think their top trials are their top trials.

If true, this is so, so, so irresponsible. Tell people that you don't know the answer! The control could easily be better than the drug! Don't give them false hope!

So agonizing.