薬理と治療

Abstract

Background This is the first attempt to conduct a large－scale phaseⅢ oncology trial usingthe Evaluation System of Investigational Medical Care（ESIMeC）.Methods The study design is a randomized phaseⅡ ／ Ⅲ trial comparing administrationroutes of carboplatin either intravenously（IV）or intraperitoneally（IP）in combination withweekly administration of paclitaxel for ovarian cancer patients. Target accrual is 746. Both IPcarboplatin and weekly paclitaxel have not been approved for national insurance coverage inJapan.Results Because of the expensive drug cost, it was first assumed impossible to conduct thetrial if the study chair is responsible for purchasing the investigational drugs from the limitedresearch grant or the patients have to pay for the investigational drugs without insurancecoverage. Therefore, we negotiated with the pharmaceutical companies including genericmakers to supply the investigational drugs with free of charge. The duration from initial consultationto the Ministry of Health, Labor, and Welfare to the finial approval to conduct thetrial using ESIMeC was 8 months.Conclusion The ESIMeC appears to be an efficient system as the official evaluation processof investigator－initiated, non－indication directed clinical trials, which manifestly requirequality control of the trials. However, cost coverage for the investigational medicine or techniqueremains as an important issue to be resolved in the future, especially in large phaseⅢoncology trials.（Jpn Pharmacol Ther 2010；38 suppl 1：S59－64）