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Building Better Safety Profiles With Real-World Data & Evidence

The use of real-world data has exploded in recent years and will continue playing a crucial role in 2018. Almost every major pharmaceutical and medical device company conducts real-world studies to build better safety profiles for their products, as well as support initial study findings.

Real-world data can come from a variety of sources including insurance claims databases, medical records, national registries, social media, and mobile devices.

According to Professor William Sandborn, M.D., chief of the Division of Gastroenterology at the University of California San Diego, “Real-world evidence plays an important role in helping healthcare providers evaluate a therapy’s effectiveness and safety in routine medical practice against clinical trial results.”

Over the past year, many companies have reported results that confirm the effectiveness of their products and highlight how one product is better than another. Companies have also shown that they can achieve better outcomes.

The importance of real-world data is evident across the industry and can be heard in presentations delivered by scientific leaders. When commenting on a particular study, Rory O’Connor, M.D., chief medical officer of Pfizer Internal Medicine, said: “We believe real-world data analyses via the ACROPOLIS program are helping to advance deeper levels of insight into how different patient demographics, comorbidities, and disease severity factor into how Eliquis may impact patient outcomes.”

Fortunately, the FDA has also increased its focus on the benefits of real-world data and evidence to understand a product’s safety and effectiveness.

In an August 2017 guidance document, the regulator said, “While FDA encourages the use of relevant and reliable RWD, this guidance neither mandates its use nor restricts other means of providing evidence to support regulatory decision-making.”

To learn about other trends that we can also expect to see in 2018, click here.

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Eugene Sefanov

Director, Industry and Regional Marketing

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