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System and Method for Supporting Pragmatic or Practical Clinical Trial

机译:支持务实或实际临床试验的系统和方法

摘要

The present invention relates to a practical clinical trial support system and method, the method according to the present invention for the patient screening criteria for clinical trials of the test drug, information on the control drug administered to the control and efficacy evaluation for the control drug administration Step of inputting clinical design conditions including clinical variable items, patient information of a trial group participating in a trial study to which a trial drug is administered, and a control group participating in a trial study to which a control drug is administered, determined to actually participate in the trial Step, extracting EMR control candidates satisfying the clinical trial design conditions from the EMR database storing the electronic medical records, and covariate distribution between the clinical trial control group and the clinical trial participation test group consisting of the EMR control candidate and the clinical trial participation control group And selecting a part of the EMR control candidates as a control patient through propensity score matching so that the similarity satisfies a predetermined criterion. The present invention reduces the target number of control patient recruitment required in a randomized clinical trial and reinforces the test result data collected in the actual situation to help in terms of validation, and in the case of rare diseases, it is very difficult to recruit control patients There is an advantage that it can serve as an easy reinforcement data in risk-benefit analysis for item approval by comparing and presenting the control group in.
机译:本发明涉及一种实用的临床试验支持系统和方法,根据本发明的方法,用于测试药物临床试验的患者筛选标准,给予对照药物的对照药物信息和对照药物功效评估给药确定包括以下各项的临床设计条件的步骤:确定临床试验条件,其中包括临床变量项,参加试验药物的试验组的患者信息和参加试验药物的对照组,该试验组参加了试验药物,该对照组参加了试验药物。实际参与试验步骤,从存储电子病历的EMR数据库中提取满足临床试验设计条件的EMR对照候选物,并在由EMR对照候选物和临床试验参与续rol group并且通过倾向得分匹配选择一部分EMR控制候选者作为对照患者,以使相似度满足预定标准。本发明减少了在随机临床试验中所需的对照患者招募的目标数量,并且增强了在实际情况下收集的测试结果数据以帮助进行验证,并且在罕见疾病的情况下,很难招募对照患者有一个优势,它可以通过比较并显示对照组来作为风险效益分析中的简单增强数据,以进行项目批准。

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