Value,methods and challenges of applying patient experience data in real-world study of drugs
10.6039/j.issn.1001-0408.2024.23.02
- VernacularTitle:患者体验数据应用于药物真实世界研究的价值、方法与挑战
- Author:
Lele ZHANG
1
;
Keying ZHU
1
;
Duanning WANG
1
;
Yuying HE
1
;
Zuoqi DING
1
Author Information
1. 中国药科大学国际医药商学院,南京 211198
- Publication Type:Journal Article
- Keywords:
patient experience data;
real-world study;
regulatory decision-making;
patient-reported outcome
- From:
China Pharmacy
2024;35(23):2844-2850
- CountryChina
- Language:Chinese
-
Abstract:
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.
