Analysis of the evaluation mechanism and methodology of clinical comprehensive evaluation cases of drugs in China
- VernacularTitle:我国药品临床综合评价相关案例评价机制及方法学探析
- Author:
Yuan QIAO
1
,
2
;
Fangyi MA
1
,
2
;
Yubei HAN
1
,
2
;
Mingyue ZHAO
1
,
2
;
Minghuan JIANG
1
,
2
;
Yu FANG
1
Author Information
1. Dept. of Pharmaceutical Administration，School of Pharmacy，Xi’an Jiaotong University，Xi’an 710061，China
2. Center for Drug Safety and Policy Research，Xi’an Jiaotong University，Xi’an 710061，China
- Publication Type:Journal Article
- Keywords:
clinical comprehensive evaluation of drugs;
evaluation mechanism;
methodology;
index system;
policy
- From:
China Pharmacy
2025;36(2):146-153
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To sort out the evaluation mechanism and methodology of published cases of comprehensive clinical evaluation of drugs in China， and provide a reference for promoting standardized comprehensive clinical evaluation of drugs and strengthening policy transformation in China. METHODS Clinical comprehensive evaluation cases of drugs published in China from CNKI， Wanfang Data， PubMed and Web of Science were systematically searched， and the retrieval time was from the inception to December 31st， 2023. The summary and analysis were performed from the aspects of theme selection， indicator system construction， evaluation methods， comprehensive decision-making， quality control， etc. RESULTS A total of 143 pieces of literature were ultimately included from 2014 to 2023. The number of publications has shown a rapid upward trend since 2019. The subjects of the evaluation cases were mainly pediatric drugs， Chinese patent medicines， cardiovascular drugs and anti-tumor drugs. The evaluation dimensions were between 3-8， all involving safety and effectiveness dimensions. Most cases adopted rapid evaluation methods based on literature review and expert interviews/questionnaire surveys with less emphasis on real-world research. Most cases did not involve comprehensive decision-making， quality control， or policy transformation. CONCLUSIONS The clinical comprehensive evaluation of drugs in China has made rapid progress under the guidance of national policies. However， there are still issues and challenges such as incomplete evaluation methods and standards， few cases of evaluation results being converted into decision-making， and a lack of quality control mechanisms. It is suggested that standardized evaluation paths and quality control mechanisms should be explored； when the evidence-based basis is insufficient， real-world research should be conducted as much as possible， so as to accelerate the policy transformation of evaluation results.
