Research On Quality Improvement Of Real World Data

On January 3,2020,the National Medical Products Administration(NMPA)issued the No.1 document "Guiding Principles for Drug R&d and Evaluation Supported by Real-world Evidence(Trial)",which attracted high attention from the industry and academia.Real world evidence is based on real world data,which is deeply processed by scientific research methods to form real world evidence for regulatory decision-making.In foreign countries,real world evidence has long been used to evaluate the safety and efficacy of drugs.Due to the extrapolation limitation of randomized controlled clinical trials,their implementation requires high capital and time costs,which promotes the birth of real world research.Therefore,the participation of real world evidence in regulatory decisions is a profound change in the concept of drug regulation in China.At present,China’s real world research is on the rise,and the application of real world evidence to support drug r&d and regulatory decisions has a broad prospect,but there are still many challenges in its applicability,data governance,research methods and so on.As the basis of real world evidence,improving the quality of real world data is an urgent problem to be solved.This paper focuses on the evaluation of real world data quality and how to improve real world data quality in order to promote the development of real world research.Based on relevant concepts,this paper analyzes the process of foreign real world research through literature analysis,and analyzes the key factors affecting the quality of real world data in combination with the problems and challenges faced by China’s real world research.Based on fuzzy evaluation theory,a real world data quality evaluation model is constructed.The effectiveness of the model is illustrated by an example.It can be seen from the example that,in order to improve the quality of real world data,we should make targeted improvements from various aspects such as content accuracy,source reliability,format and coding uniformity,data traceability and technical support,so as to improve the quality of real world data.In this paper,based on a real world data quality improvement Suggestions,based on real world data sharing platform,creative use block chain technology can solve the current data,data authenticity,reliability is not strong,data quality is not higher fundamental problems in the research of the real world,set up to block chain technology for real world data collection and analysis of the underlying architecture model of the database.The blockchain medical information sharing platform has been built to realize data sharing between medical institutions and between medical institutions and research institutions,and to explore and solve the accuracy,reliability,traceability and technical support of real world data.