Clinical outcome assessment (COA) accreditation methods and progress_Chinese Journal of Evidence-Based Medicine

Authors：

MA Yucong ¹ , JI Zhaochen ¹ , ZHANG Chenyao ¹ , WU Xiaolei ¹ , SHI Menglong ¹ , DU Liang ² , LIU Binglin ³ ,  CAO Lujia ¹ ,  ZHANG Junhua ¹

1. Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, P. R. China;
2. Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University, Chengdu 610041, P. R. China;
3. Center for Drug Evaluation, China Food and Drug Administration, Beijing 10002, P. R. China;

Corresponding author：

CAO Lujia, Email: caolujia0825@163.com; ZHANG Junhua, Email: zjhtcm@foxmail.com

Keywords：

Patient-focused; Qualification certification; Clinical outcome assessments

DOI：

10.7507/1672-2531.202311163

Video：

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In order to ensure the scientific and recognized evaluation of patient-centered clinical research outcomes, the drug development tool qualification certification website of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have disclosed the information of COA submitted for certification, and encouraged the use of certified COA. This paper searched all COA and approval decisions in the website, analyzed the submitted information and certification status of COA, and interpreted the certification technology and process of COA, so as to provide references and suggestions for the development of patient-centered clinical research outcome evaluation.

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1. FDA. Patient-focused drug development: collecting comprehensive and representative input guidance for industry, Food and Drug Administration staff, and other stakeholders. 2020.
2. FDA. Patient-focused drug development: methods to identify what is important to patients guidance for industry, Food and Drug Administration staff, and other stakeholders. 2022.
3. FDA. Patient-focused drug development: selecting, developing, or modifying fit-for-purpose clinical outcome assessments. 2022.
4. FDA. Patient-focused drug development: incorporating clinical outcome assessments into endpoints for regulatory decision-making. 2023.
5. FDA. Qualified clinical outcome assessments (COA). 2021.
6. FDA. Clinical Outcome Assessment (COA) qualification program. 2020.
7. FDA. Division of clinical outcome assessment (DCOA). 2023.
8. 张新宇, 周孟, 张清, 等. 关于以患者为中心药物开发的见解—现有药物评价体系的重要补充. 中国食品药品监管, 2021(4): 44-51.
9. 国家药品监督管理局药品审评中心. 《以患者为中心的临床试验设计技术指导原则(征求意见稿)》. 2022.
10. 国家药品监督管理局药品审评中心. 《以患者为中心的临床试验获益-风险评估技术指导原则(征求意见稿)》. 2022.
11. 国家药品监督管理局药品审评中心. 《以患者为中心的临床试验实施技术指导原则(征求意见稿)》. 2022.
12. 国家药监局药审中心. 关于发布《以患者为中心的药物临床试验设计技术指导原则(试行)》《以患者为中心的药物临床试验实施技术指导原则(试行)》《以患者为中心的药物获益-风险评估技术指导原则(试行)》的通告(2023年第44号). 2023.
13. 陶继华, 杨明莹, 刘玉芹, 等. 基于CiteSpace国内患者报告结局可视化分析. 全科护理, 2023, 21(27): 3751-3754.
14. 陈一飞, 董文彬, 孙搏, 等. 去中心化药物临床试验实施模式和合规关注点讨论. 中国新药与临床杂志, 2023, 42(8): 507-513.
15. 周跃华. “以患者为中心”的中药新药药学研究与评价的思考与实践. 中草药, 2022, 53(13): 3889-3896.
16. 范大超. 入组率的分析方法以及受试者的依从性. 中国处方药, 2010(3): 70-71.
17. 齐欣. 以患者为中心贯穿药研全周期. 医药经济报, 2023.
18. 崔鸿雁, 吕兰青, 邵明义, 等. 以患者为中心进行中医药临床研究的思考与探讨. 中华中医药杂志, 2022, 37(12): 7224-7227.
19. 吴晓蕾, 史梦龙, 张晨瑶, 等. 以患者为中心药物研发相关概念介绍. 中国循证医学杂志, 2023, 23(12): 1472-1477.
20. 庄铭, 安佳丽, 钟梦媛, 等. 中医药临床疗效评价方法研究进展. 中国中药杂志, 2023, 48(12): 3263-3268.

Chinese Journal of Evidence-Based Medicine

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