Under the "patient-centered" drug regulation concept,the inclusion of patient dimensions in real-world evidence becomes increasingly important. Patient experience data can complement and interpret existing data,generate evidence directly from patients,and achieve patient participation in drug development. Data types include patient-reported outcomes and free-text data,which can be collected autonomously or obtained from databases. Application scenarios involve new drug registration,safety evaluation,and additional indications. In China,applying patient experience data to real-world study mainly faces the following challenges:lack of conditions,standards,and motivation to collect high-quality data,a single type of data,and the difficulty of balancing data security with freedom,etc. It is recommended to issue special guidelines,establish a measurement tool certification process,expand data collection channels,explore data source integration methods,optimize the informed consent mechanism,and establish an evidence synergy mechanism to promote the practical application of the "patient-centered" concept in real-world study of drugs.
维普
万方数据