Real-world evidence – is it the sacred answer or a load of hype?

Real-world evidence (RWE) is a red-hot topic in the life sciences community. And for good reason – it’s changing the landscape of drug development, speed of delivery, improving efficacy and safety measures for patients and contributing to many regulatory decisions.

In fact, by the start of last year, the US Food and Drug Administration (FDA) had approved more than 20 drugs that included RWE as part of their regulatory submissions.

The first drug to be approved by the FDA with RWE included was Merck’s cancer drug Keytruda in 2017.

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