ABSTRACT
This chapter discusses some advanced designs and methodologies used for analyzing RWE. It employs a platform RWE design that encompasses multiple treatment arms to provide a comprehensive evaluation of the comparative effectiveness of tafasitamab with respect to other potential treatments for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In December 2018, FDA published a new strategic framework for FDA's Real-World Evidence program. In Dec 2021, FDA published the draft guidance on Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products. Li et al. reviewed and summarized how to use external groups in clinical development with RWE and historical data through multiple case studies. The study collected retrospective data from patients diagnosed with DLBCL between 2010 and 2020 from various academic hospitals, public hospitals, and private practices across Europe, North America, and the Asia-Pacific region.
