3．Roles and Responsibilities of Trial Statisticians / 薬剤疫学

ABSTRACT

The fundamental issues which underlie research misconduct of Diovan case are 1）lack of data-quality control system managed by a competent data manager, 2）absence of trial statistician with sufficient knowledge of methodology (from all the aspects such as scientific, ethical and operating), 3）lack of standard operating procedures (SOPs) to secure blinding of assessors and independence of interim data analysis, which eventually allowed the investigators and statisticians to improperly check and edit crucial data in the midst of the trial. The Biometric Society of Japan, the community of Japanese biostatisticians, issued “The Biometric Society of Japan statement for clinical trials” , established “Statisticians standard of conducts” , and started the Accreditation for Trial Statistician from 2017. Many clinical trials sponsored by universities or research institutes (excluding investigator-initiated TIKEN) are not equipped with SOPs, adequate logistics, and clear responsibility. Moreover, a fair number of so-called “trial statisticians” only provide sample-size calculation and technical aspects of data analysis as statistical consultation. Academia should learn from Diovan case and pursue its role of educating creditable trial statisticians who bear social responsibility and establishing their social status.