Deepen the transparency concept of clinical research and strengthen whole-process supervision and administration of research
10.3760/cma.j.issn.1006-1924.2019.02.015
- VernacularTitle:深化临床研究透明化理念 加强对研究全过程的监督及管理
- Author:
Chongya DONG
1
;
Li YANG
;
Hongbin HAN
;
Xiaoyan YAN
;
Chen YAO
Author Information
1. 北京大学第一医院医学统计室 100034
- Keywords:
Clinical research;
Transparency;
Source data;
Process supervision;
Traceability
- From:
Chinese Journal of Medical Science Research Management
2019;32(2):146-150
- CountryChina
- Language:Chinese
-
Abstract:
Objective To acquire specific suggestions for improving the transparency of clinical research.Methods Summarize main challenges for transparency in clinical research,propose possible solutions.Results Currently the common practice of clinical research transparency is to promote study registration in the beginning phase,and reporting guildlines,data sharing in the end phase of the study.The main challenges identified in clinical research transparency are (1) lacking awareness of transparency among investigators,(2) poor data integrity and traceability of research data resulted by the ignorance of transparency during study implementation process.To face the challenges,investigator should be more proactive and related research administration should be streamlined.Conclusions To improve the transparency of clinical research,better understandings of the concept of clinical research transparency for investigators and whole-process supervision from the administrative aspect should be strengthened.Furthermore,advanced information technology should be adopted to construct a hospital-based source data platform for complete clinical research process management,it helps in promoting research data quality and could become a suitable tool for clinical research administration in hospitals.Ultimately,full research transparency would be achieved.
