Common review comments on investigator initiated study (IIS) design and considerations
10.3760/cma.j.issn.1006-1924.2017.06.018
- VernacularTitle:学术性临床研究项目评审中常见设计问题及思考
- Author:
Ping JI
1
;
Haibo WANG
;
Aifa TANG
;
Huijuan LI
;
Ping XIAO
;
Yangfeng WU
Author Information
1. 北京大学香港科技大学医学中心
- Keywords:
Investigator-initiated study;
Review;
Study design
- From:
Chinese Journal of Medical Science Research Management
2017;30(6):477-480
- CountryChina
- Language:Chinese
-
Abstract:
Objective More and more investigator initiated studies have been funded in China.Both institutions and investigators should take the responsibility for meeting the scientific validity,ethical requirement,feasibility and interdisciplinary management requirements during the clinial research project design and initiation.This article hereby analyzed and summarized the most common review comments on clinical research applications.Methods Summarize the problems identified during the review of Shenzhen Second People's Hospital Clinical Research Program applications.Results The most common findings in turn as follows:inappropriate sample size calculation,study design,parameters,unclear study aims,insufficient study rational.Conclusions To fund clinical research programs with significant scientific values and appropriate design,it is vital for the research management department to provide more supervision and technology support.
