熊本大学における多施設共同医師主導治験の業務委託契約に関する対応

抄録

The purpose of this paper is to describe problems encountered in the course of conducting a government-funded inaugural investigator-initiated clinical trial in the Department of Otolaryngology-Head and Neck Surgery at Kumamoto University Hospital. A principal area of difficulty involved the process of executing contracts between the hospital and various clinical research organizations (CRO). As government funds were disbursed year by year, the budget office of the university hospital required annual budgets, rather than allowing for a single budget encompassing the 3 years of the trail, which would have enabled us to make multi-year contracts with each CRO. While the function of each CRO was clearly established, it was exceedingly difficult to estimate exact timing of services rendered by a given CRO in order to calculate the percentage of work to be accomplished in a given year. As one function of some CROs was to provide data, it was possible for a fiscal year to close without any visible product. The university hospital had difficulty understanding the reality of the situation. In addition, as the government required an open bidding process for contracts with CRO's, this annual process resulted in excessive expenditure of resources. Being the first clinical trial performed by our department, as well as at the university hospital, significant time and energy had to be devoted to developing protocol and establishing a working framework for the trials to take place. Staff members of the university contract office were generally unaware of standard procedures for clinical trials, requiring considerable explanation.