Application of patient preference information in premarketing decision of medical products in the United States and its implications
- VernacularTitle:患者偏好信息在美国医疗产品上市前决策中的应用及启示
- Author:
Xiaoyue REN
1
;
Jianzhou YAN
1
;
Ruilin DING
1
;
Rong SHAO
1
Author Information
1. Research Center of National Drug Policy & Ecosystem，China Pharmaceutical University，Nanjing 211198，China
- Publication Type:Journal Article
- Keywords:
patient preference;
drug;
medical device;
premarketing decision
- From:
China Pharmacy
2024;35(19):2321-2327
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide reference for the application of patient preference information in China by studying the application of patient preference information in the premarketing decision-making of medical products in the United States. METHODS The literature research method was used to explore the general situation， legal basis， and participants of the collection and application of patient preference information in the United States， analyze the application of patient preference information in premarketing decision-making of medical products in detail， and analyze the application status and challenges of patient preference information in China， so as to put forward suggestions. RESULTS & CONCLUSIONS United States has promoted the collection and application of patient preference information through several patient participation projects and legislation. The patient preference information is used to support premarketing decision-making of medical products： providing information for medical product development and design， and assisting clinical trial design in the research and development process； helping to support FDA’s marketing approval decisions， identifying patient groups whose benefits outweigh risks， and included in medical product descriptions in the marketing approval process. The application of patient preference information in China lacks the guidance of higher-level legal documents， and there are no targeted guidance documents. It is suggested that China should learn from the experience of the United States and clearly encourage the research and application of patient preference in higher-level legal documents； develop specific guidance documents for the collection and application of patient preference information； determine the weight and form of patient preference information to be considered in regulatory decision-making according to national conditions.
