Analysis and reflections on construction of clinical research methodology support system by IITs: Demonstration examples from construction of MACRO in Shanghai Jiao Tong University School of Medicine
10.3760/cma.j.issn.1006-1924.2019.06.016
- VernacularTitle:研究者发起的临床研究方法学支撑体系建设思考——以上海交通大学医学院临床研究中心MACRO建设为例
- Author:
Zhe SUN
1
;
Li XIE
;
Tienan FENG
;
Wenwen LV
;
Biyun QIAN
Author Information
1. 上海交通大学医学院临床研究中心 200025
- Keywords:
Investigator initiated trials;
Support system;
Research management;
Methodology of clinical research
- From:
Chinese Journal of Medical Science Research Management
2019;32(6):469-473
- CountryChina
- Language:Chinese
-
Abstract:
Objective To improve clinical research capability and quality,this study aims to explore the methodological support system of Investigator Initiated Trials (IITs).Methods By comparing the clinical research supporting system between commercial and academic organization at home and abroad,this study summarized their characteristics and make systematic analysis combined with IITs.Results Compared with international level,there is an urgent need to improve of domestic,professional support for clinical research.Academic clinical research supporting academic system could better satisfy the requirement of IITs in China.Taking Shanghai Jiao Tong University School of Medicine as an example,this paper introduces the a collaborative construction model,namely Multiple-center Academic Clinical Research Organization (MACRO),based on two levels of clinical research institutes in university and affiliated hospitals.At universities level,we focused on development of clinical research,top-level study design,clinical research methodology,clinical research professionals and standardized clinical research platform.At hospitals level,project process management can be emphasized,and which will be the main implementation content to build an applied clinical research technology center in MACRO.Conclusions With the construction of MACRO,the functional module paradigms of academic clinical research centers in university can be effectively linked to affiliated hospitals.This will be conducive for establishing collaborative support system,which is centered on academic research and complementary functions with multiple centers,improving full-time technical team and further enhancing the scientific validity and research quality of IITs.
