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Real-world evidence

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Note from the editor

Until recently, the most commonly prescribed blood thinner was warfarin, a drug first approved in 1954.

New oral anticoagulants like Bristol-Myers Squibb and Pfizer's Eliquis slowly eroded warfarin's market position. Still, it took years and more than a dozen major clinical studies for Eliquis and its chief rival, Johnson & Johnson's Xarelto, to overtake the decades-old drug.

For Bristol-Myers and Pfizer, a large part of the companies' push to win over doctors centered on data from real-world use of Eliquis across hundreds of thousands of patients. Such findings, which when appropriately analyzed are termed real-world evidence, have helped to reinforce the drug's potential benefit and the economic case for its use.

Once an afterthought, real-world evidence is becoming core to other drugmakers' efforts to prove their products in areas like oncology. New tools, such as wearable devices, have helped make gathering the vast amounts of information required more feasible. And a more open regulator means companies are more likely to consider how real-world evidence can help.

The main knock on real-world evidence's utility, though, is its reliability. Medical record and claims data are notoriously messy and conducting studies that draw meaningful correlations can be difficult or impossible. Accepting real-world evidence as a replacement — rather than a supplement — to randomized studies, experts warn, opens the door to potentially misleading associations and conclusions.

Still, with regulators, drugmakers and payers pulling in similar directions, real-world evidence could soon become a more central feature of drug development and review.

Ned Pagliarulo Senior Editor

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What You Need to Know About Real-World Evidence

Once an afterthought, real-world evidence is becoming core to other drugmakers' efforts to improve their products in areas like oncology. New tools, such as wearable devices, have helped make gathering the vast amounts of information required more feasible. And a more open regulator means companies are more likely to consider how real-world evidence can help.

included in this trendline
  • FDA 'open for business' in considering real-world evidence
  • Real-world evidence secures Pfizer expanded Ibrance approval
  • FDA officials see 'missed opportunity' with patient outcomes in clinical trials
Our Trendlines go deep on the biggest trends. These special reports, produced by our team of award-winning journalists, help business leaders understand how their industries are changing.
Davide Savenije Editor-in-Chief at Industry Dive.