Lessons From China And The United States On The Use Of RWE In Regulatory Submissions

By Martin Roessner, Corporate Vice President, Biostatistics; David Brown, VP, Epidemiology; and Sheng Feng, Ph.D.（冯胜）, Corporate Vice President, RWE APAC

In 2020, as the world urgently sought vaccines and therapeutics to combat the global coronavirus pandemic, the use of Real-World Evidence (RWE) gained significant momentum. RWE emerged as a critical tool for accelerating drug and vaccine development, offering a faster and more cost-effective pathway. This approach also provides substantial benefits for clinical trial patients, particularly those with rare and life-threatening diseases. For instance, RWE-based external control arms can be used in clinical trials to ensure that patients receive active treatments rather than being assigned to placebo groups, thereby enhancing the ethical considerations of trial design.

The United States and China have been at the forefront of exploring how RWE can support regulatory decision-making, setting the stage for broader global adoption. At Parexel, we have gained valuable insights into how companies can improve their collection of real-world data (RWD) and generation of RWE. In this article, we share our most significant lessons, offering guidance on how to harness the full potential of RWE to drive innovation and efficiency in drug development.