Lessons from China and the United States on the use of RWE in regulatory submissions

As the world raced to develop vaccines and therapeutics to combat the global coronavirus pandemic in 2020, the use of real-world evidence (RWE) accelerated because it offers an opportunity to support faster, more cost-effective drug and vaccine development. It also benefits clinical trial patients with rare and life-threatening diseases. For example, RWE-based external control arms could ensure patients receive an active treatment in a clinical trial, rather than be allocated to a placebo control regimen. The United States and China are at the forefront of exploring how RWE could support regulatory decisionmaking.

At Parexel, we’ve learned how companies can be more effective at collecting real-world data (RWD) and generating RWE. In this article, we share our most valuable lessons.

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