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 100022, 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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Abstract Full text Figures/Tables Video References Cited by

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 Copy

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Chinese Journal of Evidence-Based Medicine

Clinical outcome assessment (COA) accreditation methods and progress

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