適正な治験実施のための薬剤師治験コーディネーターの役割 : スクリーニング支援と治験中止例への対応

概要

論文の詳細を見る
To ensure that clinical trials are conducted in accordance with the new GCP guidelines, our pharmacists started acting as clinical research coordinators (CRC) in November, 1999. In the present study, we examined the CRC's support of the enrollment and withdrawal of patients for clinical trials. Between November, 1999 and April, 2003, a total of 138 patients had originally been enrolled for trials but on the basis of closer examination by CRCs, 31 of these patients (22.5%) were considered to be in contravention of the inclusion criteria. For 64.5% of them (20/31), there were problems with drugs in their prescriptions from other hospitals or our own hospital, involving contraindicated drugs or drugs given to treat complications. Regarding withdrawal from trials, 28.6% (6/21 patients) stopped participating voluntarily suggesting that a large number of patients had feelings of anxiety concerning the effects of the new drugs and their adverse reactions. We felt that the efforts of CRCs in checking prescriptions for problem-causing drugs prior to obtaining patient consent to participate in trials and continuous follow-up of subjects during trials were very useful, and that pharmacists can make an important contribution to ensuring that clinical trials are conducted properly.
日本医療薬学会の論文
2004-10-10