All Times EDT
Keywords: RWD, natural history
In recent years, the scope of natural history study has continuously evolved and its application has been broaden beyond understanding disease epidemiology or examining real world treatment patterns. Natural history study generates evidence to benchmark clinical outcomes of interest and provides patient insight regarding disease and standard of care, supporting both the development and commercialization needs. In this talk, different RWD possibilities for building a natural history study from existing data, prospective data, and their combination will be discussed. Case studies on innovative ways to leverage RWD for natural history studies will be reviewed, e.g., treating the natural history as an external comparators, supporting long-term follow up, and integrating into pragmatic trials.