I wanted to talk a little bit about randomized control trials in cancer medicine.

This is getting back to my roots a little bit.

And this is based on things I've been seeing and reading online, things I've been hearing,

things that have been written in academic medical journals.

There are a lot of misconceptions about randomized control trials and cancer medicine, drug approval.

I'm getting a little sick of what I'm hearing.

And the FDA is trying to lower the bar further. They're saying we need more

accelerated approvals. Oh, wonderful, wonderful. Just what we didn't need from this FDA that has set

the bar so low. We used to trip over it, but now no longer it's just firmly on the floor. That's where

the bar is. So let's talk about randomized control trials. First, is it hard to do a randomized

control trial? The answer is absolutely yes. We have to

start by acknowledging. It's very difficult. It's often costly. It's very tedious. There's a lot of

paperwork. There's a lot of naysayers along the way. A lot of veto powers along the way. It's very

hard to do a randomized control trial. So credit where credit is due when people do one. Yes, good for you.

You did a randomized trial. Good for you. But you overcame a lot of things. That's good. But you have ethical and moral duty to a lot of people and a lot of constituents. So we're going to talk about that. But is it hard to do? Yes, it's hard to do. Now, is it costly? Well, sometimes it's costly. It's costly when you create a bureaucracy around it, a huge and overwhelming bureaucracy around

it, but sometimes it's not costly.

For instance, they did a randomized control trial called Taste.

In the Netherlands, it was done for $50 per participant.

They built a registry-based randomized trial.

It's not an observational study.

It's a registry-based randomized trial. It's not an observational study. It's a registry-based randomized trial.

It didn't cost $20,000 or $30,000 per person.

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