Real-World Data for the Drug Development in the Digital Era
Xianchen Liu
Abstract
Randomized clinical trials (RCTs) have long been recognized the gold standard for regulatory approval in the drug development. However, RCTs may not be feasible in some diseases and/or under certain situations and findings from RCTs may not be generalized to real-world patients in the routine clinical practice. Real-world evidence (RWE) generated from various real-world data has become more and more important for the drug development and clinical decision making in the digital era. This paper described real-world data, RWE, and RWE generation, followed by the characteristics and differences between RCTs and RWE studies. Furthermore, the challenges and limitations of real-world data and RWE studies were discussed.
Topics & Concepts
Real world dataReal world evidenceDrug developmentClinical trialRandomized controlled trialMedicineGold standard (test)Clinical PracticeDrugMedical physicsIntensive care medicineData scienceComputer sciencePharmacologySurgeryInternal medicineFamily medicineStatistical Methods in Clinical TrialsHealth Systems, Economic Evaluations, Quality of LifeBiosimilars and Bioanalytical Methods