Welcome back to the channel. In the last installment of randomized control trials 101, we covered Kaplan-Myer curves, time-to-event endpoints, 2-1 randomization, blinding and concealment. In this installment of randomized control trials 101, part 2, we're going to talk about surrogate endpoints. We're going to talk about control arm quality, post-protacle care, hopefully non-infriority, superiority, superiority,

designs, drug dosing. All right, let's see how much of that we actually can get through. And literally all my notes say are just those headings that I read to you. And that's about all I got. So let's see what we're going to come up with.

Endpoints.

I think when people talk about the blinding of a study or the study design,

it's intrinsically tied to the end point you look at.

So, of course, a randomized control trial, you take a bunch of people

and you randomly assign them to, for the simplicity's sake, a therapy.

But it could also be a therapeutic strategy. It could be a diagnostic test. And you go on to measure some outcome.

Now, there's a class of outcomes that intrinsically matters to people. Those are clinical endpoints like living longer and living better.

Overall survival and health-related quality of life.

But if you use health-related quality of life, you have to measure it for the course of the

cancer journey, the course of the patient's journey. You can't just measure it for the first

few months after the initiation of the randomized trial. That's going to give you a skewed portrait.

One can imagine that if you randomize somebody to using two drugs versus one drug in a space

and only measure health-related quality life at the beginning of the journey, well, the two

drugs might do better because they have a deeper response and they tend to look good up front.

But when you exhaust those true drugs, you might not have anything

left in your medicine bag.

And the person who got one drug might get a second drug later, so they might have a better

journey overall.

The analogy I like to use is if you go camping on a long hike or if you go on a marathon,

you don't just want to know your quality of life in the first few miles. That might be okay. You want to know your quality of life throughout the whole journey,

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