治験モニターの治験実施医療機関への訪問実態　―治験効率化に向けた一考察―

抄録

Clinical trial sponsors have been requested to improve the on-site visit activities of clinical research associates (CRA) in Japan, because their activities are less efficient compared with those in the European Union and the United States. Although the sponsors have taken various measures in attempts to improve on-site visit activities, it is unknown whether or not the measures are effective to improve current activities at trial sites in Japan. We therefore surveyed the on-site visit activities of CRA at the University of Tsukuba Hospital. The mean number of on-site visits made by CRA decreased from 14.4 to 10.0/year per clinical trial from 2006 to 2012. The change in number of on-site visits differed depending on the objective of visit: the number of visits for transfer of documents and meetings for explanation of clinical trial information tended to decrease, while the number of visits for source data verification (SDV) as well as delivery and return of investigational products tended to increase. Outsourcing the delivery of investigational products to general transportation companies was started from 2009 (constituting 44% of all deliveries in 2012), and the frequencies of delivery and return of investigational products had increased using interactive voice response system or interactive web response system. These findings suggest that improvement in SDV as well as delivery and return of investigational products may have improved the on-site visit activities of CRA.