<b>Methods of Providing Valid Information for Improvement of Recruitment Based on an Analysis of Voluntary Clinical Trial Participants in a University Hospital </b>

Abstract

Clinical trials should be accelerated to deliver the newly developed medicine and equipment to patients. Therefore, it is important to increase the number of candidates for clinical trials. Since February 2011, we have made original posters for recruiting clinical trial candidates and released information of ongoing clinical trials on the internet website. We have also distributed clinical trial information to the general public during the annual clinical trial educational seminar(seminar). To evaluate the effectiveness of these measures, we reviewed medical record during fiscal years 2009-2014 to identify subjects who participated in clinical trials by their own initiative. The results were compared between the period 2009-2010 before the measures were implemented(control)and for the period 2011-2014 after the measures were implemented. Although the number of participants increased apparently for 2011-2014, the difference was not significant(p＝0.054). For 2009-2014, 13 participants(57％)were referred by primary care doctors. The subjects who participated through posters and internet were significantly younger than those who participated through referral by primary care doctors(mean age：37.8 years vs. 54.7 years；p＝0.007). Although participants of the seminar responded that the image of clinical trial was improved, no person participated in clinical trial through clinical trial information distributed in the seminar. From these results, one of the best methods to recruit trial subjects may be dissemination of clinical trial information to primary care doctors for the elderly. On the other hand, the guardians who accompanied children to attend the new childrenʼs seminar in February 8, 2015 were 30 to 40 years of age(99％). These parents may be the new targets for clinical trial candidate recruitment.