多施設共同治験における倫理審査集約化の現状と課題

抄録

We conducted a survey on centralization of research ethics review for multicenter clinical trials under the Pharmaceuticals and Medical Devises Law and calculated the “deinstitutionalization (referred to review not conducted by local IRB)” rate for each type of clinical trial. We confirmed a trend of increase in overall deinstitutionalization rate from FY2008 to FY2013. The rate was 64.5% for phase III clinical trials in FY2013. However, the rate was extremely low in oncology trials, and was only 6.5%. Using our summarized data, we estimated that the resource spent on initial reviews for multicenter clinical trials amounted to 2 billion yen in 5 years. In the whole clinical trial arena, we need to consider carefully the balance between safeguarding research ethics and ensuring efficiency of the resource spent for this purpose.