关键词: 研究者发起的临床研究, 立项评估, 德尔菲法, 层次分析法

Abstract:

Objective： To explore the establishment of a scientific and reasonable evaluation system for investigator-initiated trials， so as to make the decision-making of scientific research management departments more scientific.Methods： The framework of evaluation system was developed through literature review and focus group discussion. Delphi method was used to build an evaluation system Analytic Hierarchy Process （AHP） was used to determine the weights of each indicator.Results： Ten experts were invited and two rounds of expert consultation was carried out. According to the weight， 5 indicators in the first level were the project basis （0.398 1）， research foundation （0.212 7）， research content （0.204 1）， research plan （0.105 7） and expected output and effect （0.079 4）. Among indicators in the second level， the top three were as follows， whether the research background was discussed clearly （0.229 3）， whether the research status was comprehensive （0.128 4） and whether the preliminary research foundation was solid （0.110 0）.Conclusion： The evaluation system of investigator-initiated trials was established by Delphi method and Analytic Hierarchy Process with favorable scientific and rational senses， can provide a reference for management department.

Key words: Investigator initiated trial； , Project evaluation； , Delphi method； , Analytic hierarchy process