ABSTRACT
Real-World Data (RWD) is commonly defined as data collected in a non-randomized controlled trial setting, highlighting the representativeness of RWD for an actual diagnosis, treatment process, and patient health status in real medical or health care environment. In 2018, the US food and drug administration defined RWD as data relating to the health status of patients and/or delivery of health care, which are routinely collected from a variety of sources. To address regulatory issues, an ideal data source should cover a patient population with good stability and representativeness, and contain adequate information for evidence generation. Data might be needed on various information (e.g., demographics, symptoms, signs, laboratory and imaging results, medications, surgeries, and so forth) and throughout the entire or majority of disease course (e.g., from inpatient department, outpatient department, emergency department, over-the-counter, and so forth).
