Common review comments on investigator initiated study (IIS) design and considerations / 中华医学科研管理杂志

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 followsinappropriate 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.