Viraj Narayanan Discusses the Impacts of Real-World Data on Clinical Research

The integration of real-world data into clinical research may mark a shift away from clinical trial information, said Viraj Narayanan, MBA, vice president of Life Sciences at COTA Healthcare.

Transcript

How has a growing understanding and acceptance of real-world data led to it being used more in clinical research?

When you think about the real world data movement, in the beginning of it, it really happened 5 or 6 years ago with the Affordable Care Act, where there was EMR adoption and it was forced on providers. You see this huge spike from, basically EMR adoption in the tens to the eighties in about 5 or 6 years. All this information, which used to be in a black box, is now digitized. The second main milestone was the Affordable Care Act, which essentially mandated for the first time that the federal government would consider alternatives to traditional clinical trial information, ie, real-world data. Since then, what is really driving adoption in consideration of real-world data is validation work, cross-industry validation work. So, I think about the last year and think about the Friends of Cancer research efforts that have that have come a long way. I think about Duke Margolis, and a lot of these policy stakeholders that are working with industry partners, with data companies, and sponsors, to define what are real world data endpoints. How do we consider this information in lieu of clinical trial information? Of course, the best way to advance the movement is examples. Probably the most exciting example this year was Pfizer's Ibrance being approved with no clinical trial information at all, exclusively using real world data. So, I think what we're going to see moving forward is continued applications and adoptions like Pfizer Ibrance as well as additional methodology work.