薬理と治療

Abstract

Objectives In spring 2010, revised package inserts with updated safety information of interferon（IFN）and ribavirin（RIB）provided for physicians including clinical investigators. This study investigated the way of providing information of revised package insert for clinical investigators. Methods We investigated the clinical trials with IFN and RIB in Hiroshima University Hospital from January to April in 2010. The Process for conveying information of revised package inserts of IFN and RIB were investigated by using the documents form sponsor to investigator. Results Ongoing clinical trials with IFN and RIB were 15 trials in January. In this study, 3 out of 15 clinical trials were revised Clinical Trial Consent Form by using Periodic Safety Update Report as precautions into the revised package insert. Three clinical trials was administering investigational agent during the implementation period. Clinical investigators had revised Clinical Trial Consent Form without using revised package insert information. Conclusions These results indicated that Clinical investigators should explain the reasons of the Clinical Trial Consent Form need amendment.