FDA guidance on real-world evidence

Now's the time to explore enterprise-wide data strategies.

Video Component

FDA Guidance on Real-World Evidence: Promising New Opportunities

Cynthia Senerchia: The guidance that just came out in December of last year was really trying to say where the FDA stands on the whole perspective, what they’re going to be considering as appropriate use going forward, and how it sees real-world evidence falling into the clinical research paradigm.

Kristen Buck: There’s often confusion between real-world data and real-world evidence. Real-world data is a myriad of sources of information. From electronic health records or electronic patient reported outcomes or wearables or digital devices, and when taken together it may tell a patient’s health history.


Lauren Neighbours: And so real-world evidence is actually utilizing that real-world data to help make regulatory decisions. It can help support the risk-benefit profile of a drug, and help weigh in on FDA’s decision making for safety and effectiveness for a product. 


Cynthia Senerchia: Optum’s data and solutions allows life sciences customers to see what’s happening with their drugs in the real-world.

Elenee Argentinis: And unlike never before, they’ll be able to package up that insight and go proactively and thoughtfully to the FDA to have the kind of dialogue that one would need to accelerate studies and expand their labels at a faster rate.

Kristen Buck: Because the FDA has mandated the use of real-world evidence to support regulatory decision making, Optum was at the perfect spot to take advantage of these real-world data to move the agency forward in their thinking.

Lauren Neighbours: Because of Optum’s access to data, our technology and tools, we can partner with pharma and partner with FDA both to help expand the real-world evidence framework, help develop new guidance, to help lead the industry in that respect, but also help our pharma partners to streamline the clinical development of their products.

Elenee Argentinis: One of the most promising things that this FDA guidance offers companies, is that if they are investing in real-world data, they can almost monitor and assess the performance of their therapeutics and go to the FDA more proactively about potential studies for drugs and therapeutics in market as well as new therapeutics that they are contemplating.

Kristen Buck: Optum has the data, the tools and the talent. We have those relationships with life science companies and we can work with them to move this science forward.

Elenee Argentinis: To reach patients faster than ever before.

As medical teams increase their investment in real-world data to do clinical research, the rest of the organization can benefit. No longer does HEOR, epidemiology, safety and commercial teams have to purchase slices of data. But together they can identify common questions that they all share and make an investment in a pan-therapeutic data set, or one that spans many diseases and many drug classes.

There’s never been a better time to invest in enterprise wide data.


New guidance means greater data applications

With the FDA mandating the use of real-world evidence to support regulatory decision-making, life sciences companies should give greater thought to enterprise-wide data strategies.

Companies investing in real-world data will find it easier to monitor and assess how therapeutics perform. And they can feel more confident proactively approaching the FDA about potential studies for drugs and therapeutics already in market, or new therapeutics. 

This video reviews the FDA guidance, highlighting how Optum is uniquely positioned to partner with life sciences companies and the FDA.