Guideline for the workflow of clinical comprehensive evaluation of drugs
- VernacularTitle:药品临床综合评价工作流程指南
- Author:
Zhengxiang LI
1
;
Rong DUAN
1
;
Luwen SHI
2
;
Jinhui TIAN
3
;
Xiaocong ZUO
4
;
Yu ZHANG
5
;
Lingli ZHANG
6
;
Junhua ZHANG
7
;
Hualin ZHENG
8
;
Rongsheng ZHAO
9
;
Wudong GUO
10
;
Liyan MIAO
11
;
Suodi ZHAI
9
Author Information
1. Pharmacy Center，Tianjin Medical University General Hospital，Tianjin 300052，China;Tianjin Center for Drug Use Monitoring and Clinical Comprehensive Evaluation，Tianjin 300052，China
2. Dept. of Pharmacy Administration and Clinical Pharmacy，School of Pharmaceutical Sciences，Peking University，Beijing 100091，China
3. Institute of Evidence-Based Medicine，School of Basic Medical Sciences，Lanzhou University，Lanzhou 730099，China
4. The Third Xiangya Hospital of Central South University，Changsha 422099，China
5. Union Hospital，Tongji Medical College，Huazhong University of Science and Technology，Wuhan 430022，China
6. West China Second University Hospital，Sichuan University，Chengdu 620020，China
7. Evidence- based Medicine Center，Tianjin University of Traditional Chinese Medicine，Tianjin 301617，China
8. China International Association for Promotion of Science and Technology，Beijing 100029，China
9. Dept. of Pharmacy，Peking University Third Hospital，Beijing 100083，China
10. Health Development Research Center，National Health Commission，Beijing 100044，China
11. The First Affiliated Hospital of Soochow University，Jiangsu Suzhou 215006，China
- Publication Type:Journal Article
- Keywords:
clinical comprehensive evaluation of drugs;
workflow;
guideline;
group standard;
evidence-based medicine
- From:
China Pharmacy
2025;36(19):2353-2365
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs， and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization （WHO）， strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States， and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions； research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center， and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions， including topic selection， evaluation implementation， evidence evaluation， and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs， which can effectively guide the high-quality and high-efficient development of this work， enhance the standardized output and transformation application value of evaluation evidence， and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
