基于德尔菲法构建中药注射剂上市后再评价指标体系

目的:拟建立中药注射剂上市后再评价指标体系,完善中药注射剂上市后再评价的基本框架,为推动中药上市后再评价工作提供参考依据.方法:应用德尔菲法,选择与中药注射剂上市后再评价研究相关的来自政府机构、医院、企业、学校及科研机构等行业的专家共40名,进行2轮调查,对上市后再评价指标进行筛选.结果:经两轮调查后专家权威系数平均值...

Constructing post-marketing re-evaluation indicator system for traditional Chinese medicine injection by Delphi method

OBJECTIVE To establish and optimize post-marketing re-evaluation indicator system of traditional Chinese medicine injection(TCMI)and provide references for promoting post-marketing evaluations of TCMI.METHODS A two-round Delphi consultation was held for evaluating the index of TCMI post-marketing in establishing the related re-evaluation index system.A total of 40 experts familiar with TCMI post-marketing re-evaluations were assembled from government departments,hospitals,enterprises,universities and research institutions.RESULTS The experts’authority coefficient was 0.87 after two rounds of consultation and the recovery rate of each round was 87.5%and 84.3%respectively.It indicated a high positive degree of experts.The coordination coefficient of experts was 0.615(P<0.01)in first-level indicators and 0.293(P<0.01)in second-level ones,indicating an excellent coordination on overall evaluations of expert opinions.The final evaluation system was comprised of 8 indices in first-level indicators and 35 indices in second-level ones.CONCLUSION All selected experts assume high authority and representativeness and their suggestions have an excellent consistency.The integrated application of Delphi method is both effective and reliable for post-marketing re-evaluation indicator system of TCMI.It is worthy of wider promotions.