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基于PMC指数模型的我国临床研究政策量化评价

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目的 分析我国临床研究的政策环境,为相关政策的制定和完善提供参考.方法 以我国国家层面出台的与临床研究相关的政策为研究对象,采用文本挖掘的方法筛选出政策文本中的高频词,通过构建政策建模一致性(policy modeling consistency,PMC)指数模型,从内部一致性、有效性、影响范围等多个维度,对我国临床研究的相关政策进行量化评价.结果 我国22项临床研究政策PMC指数的平均值为6.87,其中10项政策总体评价为优秀,12项政策总体评价为合格,说明国家层面临床研究政策整体质量良好,但仍有较大提升空间.结论 我国临床研究相关政策已处于高速发展阶段,相关政策基本完善,但政策之间较为独立,法治程度不足.
Quantitative evaluation of China's clinical research policies based on the PMC index model
Objective To analyze the policy environment of clinical research in China,providing valuable insights for the formulation and enhancement of policies.Methods At the national level in our country,policies related to clinical research were selected as the research subject.The method of text mining was employed to extract high-frequency words from policy texts.By constructing the policy modeling consistency(PMC)index model,evaluations of the relevant policies regarding clinical research in our country were quantified from multiple dimensions including internal consistency,effectiveness,and scope of influence.Results The average PMC index of 22 clinical research policies in our country was 6.87.Among them,10 policies demonstrated an excellent performance,while 12 policies were considered qualified.This suggested that the overall quality of clinical research policies at the national level was good,yet there was still considerable room for improvement.Conclusion Policies regarding clinical research have entered a high-speed development stage and exhibit basic completeness in China.However,these policies appear somewhat independent of each other and inadequate rule of law.

Clinical researchPMC index modelQuantitative studyPolicy evaluation

曹玥、朱培嘉、黄鹏、陈英、陈蕾

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四川大学华西医院科技部(成都 610041)

厦门大学公共卫生学院(福建厦门 361102)

四川大学华西医院临床研究管理部(成都 610041)

四川大学华西医院院长办公室(成都 610041)

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临床研究 PMC指数模型 量化研究 政策评价

四川省科技计划软科学项目四川省科技计划重点研发项目

2021JDR03762023YFS0047

2024

中国循证医学杂志
四川大学

中国循证医学杂志

CSTPCD北大核心
影响因子:1.761
ISSN:1672-2531
年,卷(期):2024.24(6)