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 clinical outcome assessment (COA) submitted for certification, and encouraged the use of certified COA. This paper searched all COA and approval decisions on 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.
Citation：
MA Yucong, JI Zhaochen, ZHANG Chenyao, WU Xiaolei, SHI Menglong, DU Liang, LIU Binglin, CAO Lujia, ZHANG Junhua. Clinical outcome assessment (COA) accreditation methods and progress. Chinese Journal of Evidence-Based Medicine, 2024, 24(8): 974-979. doi: 10.7507/1672-2531.202311163
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Copyright © the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
| 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. |
|
| 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. |
|
| 14. |
|
| 15. |
|
| 16. |
|
| 17. |
齐欣. 以患者为中心贯穿药研全周期. 医药经济报, 2023.
|
| 18. |
|
| 19. |
|
| 20. |
|
- 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.
- 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.
- 14.
- 15.
- 16.
- 17. 齐欣. 以患者为中心贯穿药研全周期. 医药经济报, 2023.
- 18.
- 19.
- 20.
Journal type citation(8)
| 1. | 石娜，安亮，卢国珍，刘建峰，李小军. 高频重复经颅磁刺激治疗卒中后抑郁的临床观察. 临床医药实践. 2022(04): 261-264 .  Baidu Scholar | |
| 2. | 秦雅鑫，张恒，闵白媛，许冬华，花志娟. rTMS对急性缺血性PSD患者5-HIAA、氨基酸类神经递质及5-HT的影响. 分子诊断与治疗杂志. 2022(10): 1741-1744 . Baidu Scholar | |
| 3. | 何流，欧阳建彬. 病灶对侧头电针结合经颅磁刺激对脑出血患者的心理影响. 湖南中医杂志. 2021(03): 75-77 . Baidu Scholar | |
| 4. | 赵静，闫莹莹. rTMS对卒中后吞咽障碍合并焦虑抑郁患者的效果. 国际精神病学杂志. 2021(02): 296-297+305 . Baidu Scholar | |
| 5. | 李红妮，贾建真，万小雪，洪登攀. 低频rTMS联合开窍醒神汤治疗急性脑损伤植物状态患者的效果. 临床医学研究与实践. 2020(09): 119-120 . Baidu Scholar | |
| 6. | 覃燕燕，李美娟，付萍萍，张玉娥. 重复经颅磁刺激在精神分裂症长期住院患者中的应用. 中国当代医药. 2020(09): 64-67 . Baidu Scholar | |
| 7. | 王晓勇，吕东岭，崔春丽，梁森. 自拟柴胡龙骨解郁汤合并rTMS治疗肝气郁结型卒中后抑郁症40例. 江西中医药. 2020(12): 50-52 . Baidu Scholar | |
| 8. | 周锦霞，潘春联. 低频重复经颅磁刺激联合尼麦角林治疗脑卒中后抑郁患者的临床疗效. 实用心脑肺血管病杂志. 2019(05): 89-92 . Baidu Scholar | |
Other types of references(7)
| 1. | 刘思芸. 重复经颅磁刺激对卒中后抑郁患者的疗效及白质纤维束弥散张量成像改变的临床研究[D]. 锦州医科大学. 2024. Baidu Scholar | |
| 2. | 周乐. 重复经颅磁刺激联合腹部推拿治疗脑卒中后抑郁的临床疗效观察[D]. 南昌大学. 2023. Baidu Scholar | |
| 3. | 武军祥. 草酸艾司西酞普兰联合重复经颅磁刺激治疗卒中后抑郁的临床研究[D]. 延安大学. 2020. Baidu Scholar | |
| 4. | 王长德. 逍遥解郁散对PSD大鼠VTA-NAc通路中BDNF的影响及其在临床中的应用研究[D]. 上海中医药大学. 2019. Baidu Scholar | |
| 5. | 刘海燕. 基于组学的卒中后抑郁发病机制及重复经颅磁刺激干预研究[D]. 重庆医科大学. 2023. Baidu Scholar | |
| 6. | 田伟平. 秦氏整体针法治疗肝郁脾虚型中风后抑郁的临床研究[D]. 广州中医药大学. 2019. Baidu Scholar | |
| 7. | 黄霞. “健脾调气法”针灸治疗肝郁脾虚型中风后轻中度抑郁症临床观察[D]. 广西中医药大学. 2019. Baidu Scholar | |
