医療統計学専門家の治験審査への参加による審査の質の改善に関する検討

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At Kinki University Hospital, the Institutional Review Board (IRB) was established in 1989 at the time that Good Clinical Practice (GCP) was introduced and since then, it has screened the clinical trials and clinical studies conducted by physicians and the number of persons in the screening committee has been increased. In April, 2005, a medical statistician was assigned to the board and preliminary screening was started for clinical studies, which has reinforced the screening process. In the present study, we determined how the content of IRB screening has changed in accordance with responses made to recommendations made by the IRB, finding that the number of recommendations by the IRB had increased 1.88-fold for clinical trials and 4.62-fold for clinical studies. The fact that they covered everything from ethical to scientific aspects indicated the highly significant role they had played. Upon classifying IRB recommendations into three categories : ethical recommendations, scientific recommendations, reliability-related and other recommendations, we found that there had been a sharp increase in scientific recommendations and that there was room for improvement in statistical screening for clinical studies conducted by physicians. The above findings demonstrate the effectiveness of the participation of a medical statistician in the IRB. We would also like to point out the importance of the person responsible for the preparation of IRB minutes (usually a pharmacist) having a knowledge of the scientific aspects of protocols, statistical aspects in particular.
日本医療薬学会の論文
2008-06-10

医療統計学専門家の治験審査への参加による審査の質の改善に関する検討

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