マイルストーン方式による治験費用の支払いの実施と検証

抄録

We have introduced the original milestone payment system in the cost management of clinical trials since September 2015. The milestone payment system is the installed payment in each study period, not the lump-sum payment at the start of the study. As there is no standard method for a milestone payment system, each institution set up an original payment system method. In our milestone payment system, the study periods are basically divided into three divisions: First period; beginning of dosage, 50％ payment, Second period; arriving at 1/3 dosage period, 25％ payment, and Third period; arriving at 2/3, 25％ payment.

The purpose of this study was to verify that the introduction of the milestone payment system optimizes clinical trial costs. The number of analysis cases was 136 in 42 pharmaceutical clinical trials, excluding those for medical devices and cellular and tissue-based products and dropout cases of the observational period. The number of cases that did not reach the final period was 27, costing 27.61 million yen by the milestone payment system, and 47.00 million yen by the lump-sum payment system. By the milestone payment system, the clinical trial cost was reduced by 41％. Therefore, the introduction of our original milestone payment system contributed to the optimization of clinical trial cost management.