| 王瑀琦,张若明,武志昂.生物等效性试验健康受试者依从性风险管理研究[J].中国药事,2020,34(3):315-324 |
| 生物等效性试验健康受试者依从性风险管理研究 |
| On Compliance Risk Management of Healthy Subjects in Bioequivalence Test |
| 投稿时间：2019-03-28 |
| DOI：10.16153/j.1002-7777.2020.03.011 |
| 中文关键词: 生物等效性试验 健康受试者依从性 风险管理 层次分析法 |
| 英文关键词: bioequivalence test compliance of healthy subjects risk management analytic hierarchy process |
| 基金项目: |
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| 摘要点击次数: 1230 |
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| 中文摘要: |
| 目的： 对生物等效性试验中影响健康受试者依从性的风险指标进行识别与评估，从而提高健康受试者的依从性，保障试验质量。方法： 以风险管理理论为指导，通过文献研究和专家访谈对影响健康受试者依从性的风险进行识别，构建风险指标体系，通过问卷调查和层次分析法对风险指标进行评估，计算各风险指标的权重。结果与结论： 影响健康受试者依从性风险因素的重要性排序依次是试验药物、受试者、研究人员、药物临床试验机构。可通过充分讲解、预防且妥善处理药物不良反应，优先选择诚信度良好的受试者，合理设计试验方案和采血点，加强受试者对试验药物及试验要求的理解，研究人员监管到位等方式，提高健康受试者依从性，从而保障试验质量。 |
| 英文摘要: |
| Objective: To identify and evaluate the risk indicators affecting compliance of healthy subjects in bioequivalence test, so as to provide references for improving compliance of healthy subjects and ensure the test quality. Methods: Under the guidance of risk management theory, the risk index system was established through literature review and expert interview, and the risk indicators were evaluated by questionnaire and analytic hierarchy process (AHP) to calculate the weight of each risk indicator. Results and Conclusion: The importance sequence of risk factors affecting the compliance of healthy subjects ranging from high to low is as follows:the experimental drugs, subjects, researchers and drug clinical trial institutions. The compliance of healthy subjects can be improved to ensure the test quality by the following actions, such as fully explaining, preventing and properly dealing with adverse drug reactions, giving priority to subjects with good integrity, reasonably designing test plans and blood collection points, strengthening the understanding of experimental drugs and requirements for subjects, and supervising researchers. |
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