薬理と治療

Abstract

Background Importance of Academic Research Organization in the area of clinical research has been increasing with the advance of building up of clinical study infrastructure in Japan. However, some studies could be terminated due to the insufficiency of subject recruitment. Objectives To find factors associated with the study failure due to insufficiency of subject recruitment by review of study management and interviews with staff. Methods A set of two studies of chemotherapy for multiple myeloma patients was analyzed. Review of studies was conducted based on the record of the studies. Four management staffs were interviewed. Results Review of studies and interview revealed five factors associated with study failure including principal investigator, role of management staff, co－investigator, protocol and trial design, and project management. Conclusions Factors associated with study failure were found by review of studies and interview. It is important to consider these factors at the planning of clinical study.