What you need to know about real-world evidence
The advent of technologies like electronic medical records and wearables has given drugmakers access to more data than ever before. But harnessing that data for use in drug reviews has raised questions about just what is acceptable and how the data should be analyzed.
A recent mandate from the 21st Century Cures Act has put the FDA on a time clock to issue cohesive guidance to industry, promising to change the regulatory process.
With this evolution in mind, BioPharma Dive is taking a closer look at the changing regulatory environment, drivers of real-world evidence, the payer perspective and the drawbacks.
Top FDA officials talk up data from outside the clinic, but the agency has yet to give the industry concrete guidance for best practices. Read More »
Healthcare shifts are driving drugmakers, payers and regulators alike toward greater use of data collected outside the randomized clinical trial setting. Read More »
Eliquis, the pharma's blood thinner, is now a blockbuster. Yet Bristol-Myers sees growth ahead, tapping real-world data to convince doctors and payers of its benefit. Read More »
After devoting considerable time and resources to find out how a product works in everyday life, drugmakers can be left with more questions than answers. Read More »
Insurers and pharmacy benefit managers are wary about the quality of data underlying real-world evidence. Read More »
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