In May 2019, the US Food and Drug Administration (FDA) released the Framework for FDA’s Real-World Evidence (RWE) Program, a draft guidance to evaluate the potential use of real-world data (RWD) in facilitating regulatory decisions. The guidance was a clear indication of the increasing importance of RWE to regulatory agencies and to the medical community. As a result, pharmaceutical companies and medical communities see patient registries as increasingly important in providing reliable RWE of treatment effectiveness and safety in clinical practice. A broad, widely accepted definition of patient registries is “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves one or more stated scientific, clinical, or policy purpose(s).” The registries that will be discussed in this article are conducted by pharmaceutical companies and are defined as large, prospective, observational (noninterventional) cohort studies of populations defined by a specific disease or a specific treatment in which data are collected longitudinally in a systematic manner from real-world clinical settings.

 Pharmaceutical companies conduct registries, as eith