RWE: Supporting Regulatory Submissions with Real-World Evidence

HIT Consultant September 15, 2021
Tiffany Siu Woodworth, Director, Analytic Solutions, Panalgo

In 2016, the 21^st Century Cures Act was signed into law, mandating that the FDA “establish a program to evaluate the use of real-world evidence (RWE) to help support the approval of new indications for a drug and to help to support or satisfy post-approval study requirements.” Along with advances in the availability and quality of real-world data (RWD) from sources like electronic health records (EHRs), registries, medical claims and pharmacy data, the Cures Act has been a catalyst for increased emphasis on using RWE in clinical and regulatory decision-making.

Today, RWE is playing an increasingly important role in life sciences research. In the last 10 years, close to 1,600 clinical trials have been registered that were informed using...

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