Value，methods and challenges of applying patient experience data in real-world study of drugs
- 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. School of International Pharmaceutical Business，China Pharmaceutical University，Nanjing 211198，China
- 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.
