Dr Miruna Sasu: Real-world Data Must Represent Diversity

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Miruna Sasu, PhD, MBA, president and CEO of COTA Healthcare, delves into how real-world data and evidence generation have changed, both within the past year and since the beginning of the COVID-19 pandemic.

Miruna Sasu, PhD, MBA, president and CEO of COTA Healthcare, delves into how real-world data and evidence generation have changed, both within the past year and since the beginning of the COVID-19 pandemic; in particular, how the more widespread use of virtual care has transformed the collection and handling of electronic data.

Transcript

Since you joined COTA, how has the field of real-world data and real-world evidence changed?

I joined COTA about a year ago in the role of chief strategy officer. A lot has changed over the past year. In fact, a lot has changed since the pandemic hit. One of the things that I would say on the on the user side and on this sort of, me trying to push things out there to make it easier for the patient and for the doctors that are treating patients, just introducing the virtual components of care has made a big difference in how we treat data and the importance of data. And so, on the COTA side, we breathe and live data every day. The idea for us is to be able to understand patients and the patient population to figure out what works and what doesn't work, and what can extend lives and what can make quality of life better.

Over the past year, I think that the environment has changed—the ecosystem has changed. The FDA has issued some guidance around how to handle electronic medical records, data, and evidence. And, of course, here at COTA, a lot has changed as well. We have a new strategy in place. We are working very closely with life science companies to perform external control arms on clinical trials using data, and we're seeing a big uptake of that in the past 12 to 18 months.

We also have large growing data sets, whereby companies can license those data sets. Those data sets can either be used for evidence generation or they can be used for training algorithms, for example. We've seen a lot of companies come up with predictive algorithms looking at predictability of care, predictability of outcomes, especially in oncology patients. Also, mobility: How are patients going to be moving from place to place in the post-COVID era? Are patients willing to continue to travel to, for example, a clinical trial site? In some cases, the answer to that is increasingly, “No,” because now they have video options and care options that are administered right at home.

And so, a lot has changed—the environment has changed, the ecosystem has changed, and COTA’s strategy has changed as well. We are making a big push on diversity and being sure that our data sets are representative of a diverse population and the epidemiologically relevant population in the United States.