Abstract
The new GCP rule created an impact on clinical trials in Japan. Medical institutes conducting clinical trials claim management costs to pharmaceutical companies under formal guidelines. The present study evaluated the actual expenses and claimed costs in a clinical trial carried out under the new GCP rule in 1999 at Tokyo Women's Medical University Hospital. The model clinical trial was of a large scale (45 cases) and was carried out with research coordinators (CRC). The claim was based on the formal guidelines and the institutional guidelines for the CRC cost. The claimed costs exceeded the actual expenses when evaluated for the model. However, when hypothetical calculation was performed on the model of a downscaled trial (5 cases, a typical scale for clinical trials in Japan), the calculated actual expenses exceeded the costs to be claimed by the guidelines. The results indicate that further consideration for the cost of clinical trials may be an economical factor in facilitating clinical trials in Japan.
