Quality assessment of real-world data

Abstract

Recently, the development of a methodology for obtaining evidence of clinical efficacy and safety of medical technologies based on the collection and analysis of real clinical practice data (real-world data; RWD; real-world evidence; RWE) has become extremely relevant. Different types of research are used in RWD/RWE. It must develop a unified methodology for conducting and approach the reliability of the results of such studies. One of these approaches is the ranking of the reliability of research results based on an assessment of the quality of the original data: patient populations, exposures, outcomes and confounding factors (interfering factors). Simultaneously, for an optimal assessment of reliability, the following should be considered: a description of the data sources implemented during the study; techniques used to transform them; the techniques used to make up for missing information in the collection of these data.