Riding In Cars With Researchers

The Japanese government just announced that they will be releasing a guidance document sometime around April of 2021, regarding how you would be able to submit data for regulatory approval there while using what's called real-world evidence in place of a placebo arm. So let's discuss this concept and what this means ethically and how it would work. It's a leap of faith for the industry to start thinking, “could we do this?”. But something that I always say is just because something's hard, doesn't mean you shouldn't do it. You should do it because it's the right thing to do. If we have enough real-world evidence data that we could leverage to eliminate placebo arms, no matter how hard it is, we should do this. We should take on that challenge.