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Statistical approaches for optimizing the design and analysis of clinical trials

优化临床试验设计和分析的统计方法

基本信息

批准号：
20K18900
负责人：
朝倉こう子
金额：
$ 1.91万
依托单位：
National Cardiovascular Center Research Institute
依托单位国家：
日本
项目类别：
Grant-in-Aid for Early-Career Scientists
财政年份：
2020
资助国家：
日本
起止时间：
2020-04-01 至 2024-03-31
项目状态：
已结题

来源：
https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-20K18900/
关键词：
臨床試験中間解析多重性小規模試験適応的デザイン

项目摘要

本研究は治療効果の臨床評価と意思決定に関し，各臨床試験の特徴や状況にふさわしい戦略をどのような規準で選択し計画すべきかといった，新規治療法の臨床開発過程において現場が直面する課題に道筋を示すことを目標とし，臨床評価における適応的な試験計画の最適化に関する統計的方法を研究することを目的とする．令和４年度は，研究実施計画ならびに前年度の成果に基づき，発展的に検討を行った．具体的には(1)解析計画の最適化，(2)仮説の適応的選択に関し，これまでに得られた成果を国内の学会にて発表し，客観的な評価を得た．とくに(2)については，仮説の選択に関する意思決定の方針，試験の早期中止や被験者数の変更等の他のデザイン変更の可能性を考慮した場合の性能について，前年度の検討より明らかになった問題点へ対処する形で方法の改良を試みた．また(3)小規模試験の計画と意思決定に関し，デザイン変更の内容として試験の早期中止や解析計画の変更に焦点をあて，前年度に整理した統計的な問題点について詳細に調査するとともに，代替としての検定統計量に分布を仮定しない方法について検討を行った．これらの検討を進める中で，現地開催での国際学会発表を断念したことや，当初は予定していなかったより詳細な検討を追加することとなったため，次年度に継続的に研究を実施し，国際学会での成果発表およびそれらの結果を含めた研究論文の準備，公表を進めることとした．

In this study, the purpose of this study is to determine the meaning of the operation of the bed, and the special conditions of each bed are selected. The standard of the system is selected. The new rules and regulations show that the road tendons in the process of operation of the bed are in the face of the problem. The purpose of the study is to study the results of the previous year, the basis of the results of the previous year, and the performance of the exhibition. (1) the analysis of the plan is optimized, and (2) the selection of the program is selected. The results show that the domestic students learn to learn the table, and the customers get the results. (2) choose to determine the meaning of the party, the number of people who have been terminated early, the number of people who have been terminated early, the more likely they are, and the more likely they are. In the previous year, we did not know that there was a problem in the previous year. The method was improved. (3) A small scale model was used to determine the meaning of the plan. in the previous year, the content of the project was changed, the content was terminated early, the program was analyzed, the focus was changed, and the previous year was sorted out. Instead of using the method to determine the distribution of statistical data, we are now urging the International Society of International Studies to conclude that there is a gap in the distribution of statistics and statistics, and that we are now urging the International Society of International Studies to make a statement on the basis of the statistics on the distribution of statistical data. The results of the International Institute of International Studies include the preparation of the research papers, and the public table is in progress.