Clinical Research Management
Deepen the transparency concept of clinical research and strengthen whole-process supervision and administration of research
Dong Chongya, Yang Li, Han Hongbin, Yan Xiaoyan, Yao Chen
Published 2019-04-21
Cite as Chin J Med Sci Res Manage, 2019, 32(2): 146-150. DOI: 10.3760/cma.j.issn.1006-1924.2019.02.015
Abstract
ObjectiveTo acquire specific suggestions for improving the transparency of clinical research.
MethodsSummarize main challenges for transparency in clinical research, propose possible solutions.
ResultsCurrently 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.
ConclusionsTo 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.
Key words:
Clinical research; Transparency; Source data; Process supervision; Traceability
Contributor Information
Dong Chongya
Department of biostatistics, Peking University First Hospital, Beijing 100034, China
Yang Li
Department of nephrology, Peking University First Hospital, Beijing 100034, China
Han Hongbin
Office of scientific research, Peking University Health Science Center, Beijing 100191, China
Yan Xiaoyan
Peking University Clinical Research Institute, Beijing 100191, China
Yao Chen
Department of biostatistics, Peking University First Hospital, Beijing 100034, China
Peking University Clinical Research Institute, Beijing 100191, China
