Viraj Narayanan Addresses the Adoption Curve Presented by Real-World Data

Education efforts among providers, payer, and patients can help answer the fundamental and important questions raised by the use of real-world data, said Viraj Narayanan, MBA, vice president of Life Sciences at COTA Healthcare.

Transcript:

What is the adoption curve like for using real-world data and how do you get more people comfortable with using real-world data?

The idea of using real world data for regulatory purposes is brand new, and like anything brand new, it should be treated and assessed like that. What we see at COTA is that there's certainly a landscape of sponsors, laggards, those in the middle, and the pioneers. The pioneers are adopting real-world data today and considering how do we actually redesign or consider bringing a clinical trial to the FDA or EMA, differently with real-world data. Those sponsors are using considerations like a single arm trial, and using a comparator cohort with real-world data. For those that are in the middle, or the laggards, a lot of the work that we see that needs to be done is frankly, the education because it's something new. So questions that we hear all the time is why isn't this real-world data the same as my clinical trial data? Why isn't data captured in a reliable format? Why aren't the patients the same? How do we create a matching cohort, from our clinical trial data to the real world data? Is the data going to have the relevant endpoints that we need in our clinical trial relative to the real-world? These are really fundamental, important questions. It's not that for those that aren't adopting, they're not thinking through these questions. I think we just need a lot of education work, frankly, across sponsors, regulators, real-world data companies to help answer those questions. That validation work will really help pave the way for how this data can be used.