“…Use of RWD to inform trial designs and generate RWE to evaluate safety and efficacy [1][2][3][4][5][6][7][8][9][10][11][12] Currently, most of the patient-derived RWD used in biomedical research resides in Electronic Health Records (EHRs). Even though their development was not intended for research purposes, the large volume of information, data richness, continuum of care data collection, and ability to be linked and integrated with additional data from medical encounters such as claims data, imaging, and laboratory information can provide a more comprehensive view of an individual and their health journey.…”