Real-world evidence cannot replace randomized blinded clinical trials
Vas Narasimhan · a16z Podcast | The Science and Business of Innovative Medicines · Jan 17, 2019 · at 41:25
Vas Narasimhan, CEO of Novartis, explains why real-world evidence is insufficient on its own to prove drug efficacy without randomized controlled trials.
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“The other thing people talk about, but I mean, I'll take a skeptical voice around it, is the ability to use real world evidence to try to get at these things. But as somebody who's worked in clinical trials for most of their time in, in the industry I do believe that, you know, the power of randomization, the power of blindedness is, is what enables us to, control for all of the things we don't know about the complexity of human life and human biology. And to think that we're going to take that away and then be able to really determine the efficacy of a medicine puts a lot on the statistics that I don't think we have. And so I, I'm more of a real world evidence. I don't know if it's a skeptic, but realist who sort of says after we have randomized placebo controlled data that really tells us that something has the effect we think it is, Then to explore more effects or explore more uses through real world evidence makes a lot of sense, but I don't see this as a panacea that suddenly will make, make the world, you know, much, much easier.”
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